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Breast Cancer clinical trials at UCSD

64 in progress, 21 open to eligible people

Showing trials for
  • A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer

    open to eligible females ages 18 years and up

    This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and PK of IV administered DAN-222 followed by a dose-escalation of DAN-222 in combination with niraparib. There are two stages within this study: Stage 1: - Part A is dose escalation of single agent DAN-222 - Part B is dose escalation of DAN-222 in combination with niraparib Stage 2: Expansion of three separate HER2-negative mBC cohorts: one group for single agent DAN-222 in subjects with HRD-positive or HRD-negative tumors and 1 cohort each for DAN-222 combined with niraparib of HRD-positive tumors or HRD-negative tumors.

    La Jolla, California and other locations

  • A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer

    open to eligible people ages 18 years and up

    This is a Phase Ib/II, open-label, multicenter, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in patients with metastatic or inoperable locally advanced TNBC. The study will be performed in two stages. During Stage 1, two cohorts will be enrolled in parallel in this study: one cohort will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort), and one cohort will consist of participants who had disease progression during or following 1L treatment with chemotherapy (e.g., paclitaxel, nab-paclitaxel, carboplatin) and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). In addition, participants in the 2L CIT-naive cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.

    La Jolla, California and other locations

  • A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)

    open to eligible people ages 18 years and up

    This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.

    San Diego, California and other locations

  • Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

    open to eligible females ages 18 years and up

    This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

    La Jolla, California and other locations

  • Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

    open to eligible people ages 18 years and up

    This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.

    La Jolla, California and other locations

  • CMP-001 in Combination With IV PD-1-Blocking Antibody in Subjects With Certain Types of Advanced or Metastatic Cancer

    open to eligible people ages 18 years and up

    CMP-001-009 is a Phase 2 study of intratumoral CMP-001 in combination with an intravenous PD-1-blocking antibody administered to participants with certain types of advanced or metatastic cancer. The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with a programmed cell death protein (PD-1)-blocking antibody in subjects with certain types of advanced or metatastic cancer. The secondary objectives are to: - To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with a PD-1-blocking antibody in study subjects. - To evaluate the efficacy of CMP-001 in combination with a PD-1-blocking antibody in study subjects. Participants will continue to receive treatment of CMP-001 in combination with a PD-1-blocking antibody according to the treatment schedule until a reason for treatment discontinuation is reached.

    La Jolla, California and other locations

  • Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer

    open to eligible people ages 18 years and up

    This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

    La Jolla, California and other locations

  • FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

    open to eligible people ages 18 years and up

    FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in subjects with advanced solid tumors.

    San Diego, California and other locations

  • I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

    open to eligible people ages 18 years and up

    The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.

    La Jolla, California and other locations

  • Improving Cognition After Cancer

    open to eligible females ages 40 years and up

    This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.

    La Jolla, California

  • Phase 1/1b Study of Oral PMD-026 in Patients With Metastatic Breast Cancer and Metastatic Triple Negative Breast Cancer

    open to eligible people ages 18 years and up

    The purpose of this study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer and triple negative breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer and triple negative breast cancer.

    San Diego, California and other locations

  • Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

    open to eligible people ages 21 years and up

    A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of August, 2022, www.radcomp.org.

    San Diego, California and other locations

  • RISE - Reduce Sitting Time Among Breast Cancer Survivors

    open to eligible females ages 50 years and up

    This 3-month study will test whether a program to reduce sitting time, for breast cancer survivors experiencing some physical limitations, can improve their physical function and other important aspects of quality of life.

    La Jolla, California

  • Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

    open to eligible people ages 18 years and up

    This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: - Find the recommended dose of BT5528 that can be given safely to participants alone and in combination with nivolumab - Learn more about the side effects of BT5528 - Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. - Learn more about BT5528 therapy alone and in combination with nivolumab.

    La Jolla, California and other locations

  • Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC

    open to eligible people ages 18 years and up

    The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.

    La Jolla, California and other locations

  • Study of CRX100 in Patients With Advanced Solid Tumors

    open to eligible people ages 18 years and up

    This clinical study is an open-label, phase 1, dose-escalation study to determine the safety, tolerability, and pharmacokinetic (PK) properties of CRX100 in adult subjects with advanced solid tumors. Patients will be screened and evaluated to determine whether or not they meet stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo generation of autologous cytokine induced killer (CIK) cells. Patients with triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, and gastric cancer will be considered.

    La Jolla, California and other locations

  • Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    open to eligible people ages 18 years and up

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

    La Jolla, California and other locations

  • Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC

    open to eligible people ages 18 years and up

    This is a Phase 2, Multi-Cohort, Open-Label, Multi-Center Study. Cohort 1 will be a single-arm study of intratumoral tavokinogene telseplasmid (tavo) plus electroporation (EP) in combination with pembrolizumab therapy. Cohort 2 will be a single-arm study of intratumoral tavo-EP plus pembrolizumab with nab-paclitaxel (Abraxane®) chemotherapy. Subjects with TNBC and EP accessible cutaneous / subcutaneous disease will be enrolled in this study.

    La Jolla, California and other locations

  • Women Informed to Screen Depending on Measures of Risk (Wisdom Study)

    open to eligible females ages 40-74

    Most physicians still use a one-size-fits-all approach to breast screening in which all women, regardless of their personal history, family history or genetics (except BRCA carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit women by detecting cancers early when they are easier to treat, but they are not perfect. Recent news stories have discussed some of the potential harms: large numbers of positive results that cause stressful recalls for additional mammograms and biopsies. With the current screening approach, half of the women who undergo annual screening for ten years will have at least one false positive biopsy. Potentially more important are cancer diagnoses for growths that might never come to clinical attention if left alone (called "overdiagnosis"). This can lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast cancers detected today may fall into the category of "overdiagnosis." This study compares annual screening with a risk-based breast cancer screening schedule, based upon each woman's personal risk of breast cancer. The investigators have designed the study to be inclusive of all, so that even women who might be nervous about being randomly assigned to receive a particular type of care (a procedure that is typical in clinical studies) will still be able to participate by choosing the type of care they receive. For participants in the risk-based screening arm, each woman will receive a personal risk assessment that includes her family and medical history, breast density measurement and tests for genes (mutations and variations) linked to the development of breast cancer. Women who have the highest personal risk of developing breast cancer will receive more frequent screening, while women with a lower personal risk would receive less frequent screening. No woman will be screened less than is recommended by the USPSTF breast cancer screening guidelines. If this study is successful, women will gain a realistic understanding of their personal risk of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe this study has the potential to transform breast cancer screening in America.

    San Diego, California and other locations

  • Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy

    open to eligible people ages 18 years and up

    Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study. The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

    San Diego, California and other locations

  • Predicting Chronic Pain Following Breast Surgery

    open to eligible people ages 18 years and up

    Breast surgery, which includes mastectomy, breast reconstructive surgery, or lumpectomies with sentinel node biopsies, may lead to the development of chronic pain and long-term opioid use. In the era of an opioid crisis, it is important to risk-stratify this surgical population for risk of these outcomes in an effort to personalize pain management. The opioid epidemic in the United States resulted in more than 40,000 deaths in 2016, 40% of which involved prescription opioids. Furthermore, it is estimated that 2 million patients become opioid-dependent after elective, outpatient surgery each year. After major breast surgery, chronic pain has been reported to develop anywhere between 35% - 62% of patients, while about 10% use long-term opioids. Precision medicine is a concept at which medical management is tailored to an individual patient based on a specific patient's characteristics, including social, demographic, medical, genetic, and molecular/cellular data. With a plethora of data specific to millions of patients, the use of artificial intelligence (AI) modalities to analyze big data in order to implement precision medicine is crucial. We propose to prospectively collect rich data from patients undergoing various breast surgeries in order to develop predictive models using AI modalities to predict patients at-risk for chronic pain and opioid use.

    La Jolla, California

  • A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549

    Sorry, in progress, not accepting new patients

    This dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in subjects with advanced solid tumors.

    San Diego, California and other locations

  • A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors

    Sorry, in progress, not accepting new patients

    This phase II trial studies cediranib maleate in combination with olaparib in treating patients with solid tumors that have spread to other parts of the body (advanced/metastatic) or cannot be removed by surgery (unresectable), including breast cancer, non-small cell lung cancer, small cell lung cancer, and pancreatic cancer. Cediranib maleate and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also block the flow of oxygen to the tumor, and may help make the tumor more sensitive to olaparib.

    La Jolla, California and other locations

  • A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

    Sorry, in progress, not accepting new patients

    The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.

    La Jolla, California and other locations

  • A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer

    Sorry, in progress, not accepting new patients

    This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer from recurring. Health Canada has not approved the sale or use of Metformin to treat breast cancer, although they have approved its use in this clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational.

    La Jolla, California and other locations

  • A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

    Sorry, in progress, not accepting new patients

    This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).

    La Jolla, California and other locations

  • A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.

    La Jolla, California and other locations

  • A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

    Sorry, in progress, not accepting new patients

    This study evaluates the safety of abemaciclib in combination therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus fulvestrant, pertuzumab plus trastuzumab with loperamide, or ongoing endocrine therapy) for breast cancer that has spread to other parts of the body.

    La Jolla, California and other locations

  • A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

    La Jolla, California and other locations

  • A Study of PY314 in Subjects With Advanced Solid Tumors

    Sorry, not currently recruiting here

    This is an open-label, multicenter, first in human, Phase 1a/1b study of PY314 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to standard of care (including pembrolizumab, if approved for that indication).

    San Diego, California and other locations

  • A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

    Sorry, not currently recruiting here

    This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors. The aims of the study are: - to assess the safety profile of TAK-500 when given alone and when given with pembrolizumab. - to assess the effects of TAK-500, when given alone and when given with pembrolizumab, on adults with locally advanced or metastatic solid tumors. Participants may receive TAK-500 for up to 1 year. Participants may continue with their treatment if they have continuing benefit and if this is approved by their study doctor. Participants who are receiving TAK-500 either alone or with pembrolizumab will continue with their treatment until their disease progresses or until they or their study doctor decide they should stop this treatment.

    La Jolla, California and other locations

  • A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

    Sorry, in progress, not accepting new patients

    This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

    San Diego, California and other locations

  • A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

    Sorry, in progress, not accepting new patients

    This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of XmAb22841 monotherapy and in combination with pembrolizumab in subjects with select advanced solid tumors.

    Encinitas, California and other locations

  • Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery

    Sorry, in progress, not accepting new patients

    This phase II trial studies how well accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not spread beyond the breast or the axillary lymph nodes (early-stage) after surgery. Radiation therapy uses a type of energy to kill cancer cells and shrink tumors. Brachytherapy is a type of internal radiation therapy that provides radiation inside the breast to any remaining tumor cells next to the space where the tumor was removed, and is given over a shorter amount of time than standard radiation therapy. Giving accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy may reduce the overall time that radiation is delivered to the tumor cells.

    La Jolla, California and other locations

  • Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) negative breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

    La Jolla, California and other locations

  • Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

    Sorry, not currently recruiting here

    This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

    La Jolla, California and other locations

  • Breast Cancer WEight Loss Study (BWEL Study)

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

    La Jolla, California and other locations

  • Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

    PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer

    La Jolla, California and other locations

  • Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.

    La Jolla, California and other locations

  • Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

    PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer.

    La Jolla, California and other locations

  • Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.

    La Jolla, California and other locations

  • Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery

    Sorry, in progress, not accepting new patients

    RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.

    PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.

    La Jolla, California and other locations

  • Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

    La Jolla, California and other locations

  • Intervening on Women's Health for Rural Young Breast Cancer Survivors

    Sorry, not currently recruiting here

    The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young breast cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young breast cancer survivors' engagement in goal-concordant oncofertility care.

    La Jolla, California and other locations

  • Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.

    PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.

    La Jolla, California and other locations

  • Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

    Sorry, in progress, not accepting new patients

    The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).

    La Jolla, California and other locations

  • PALbociclib CoLlaborative Adjuvant Study

    Sorry, in progress, not accepting new patients

    This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.

    La Jolla, California and other locations

  • S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.

    PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

    La Jolla, California and other locations

  • Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors

    Sorry, not currently recruiting here

    This is a Phase 1/2, open-label, multicenter, non-randomized study to investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid to subjects with previously treated, locally advanced or metastatic solid tumors which are HER2 amplified/overexpressed.

    La Jolla, California and other locations

  • Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

    La Jolla, California and other locations

  • Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer

    Sorry, in progress, not accepting new patients

    This is a pilot phase 1b study to investigate the safety and side effects of combining the ROR1-targeting monoclonal antibody, cirmtuzumab, with paclitaxel for patients with HER2 negative, metastatic breast cancer. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called receptor-tyrosine-kinase like orphan receptor 1 (ROR1) on the surface of breast cancer cells. Cirmtuzumab blocks the growth and survival of the breast cancer cells in laboratory tests. ROR1 is rarely expressed on healthy cells. Cirmtuzumab is considered experimental and is not approved by United States (U.S.) Food and Drug Administration (FDA).

    La Jolla, California

  • Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4). The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6. Approximately 270 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.

    San Diego, California and other locations

  • Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

    La Jolla, California and other locations

  • Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

    PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.

    San Diego, California and other locations

  • SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.

    San Diego, California and other locations

  • Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body and has estrogen receptors but not human epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in treating patients with breast cancer.

    La Jolla, California and other locations

  • Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.

    La Jolla, California and other locations

  • Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized phase II trial studies how well olaparib with or without atezolizumab work in treating patients with non-HER2-positive breast cancer that has spread from its original site of growth to nearby tissues or lymph nodes and is not amenable to surgical resection (locally advanced unresectable) or has spread to other places in the body (metastatic). Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. It is not known whether giving olaparib with or without atezolizumab will work better in patients with non-HER2-positive breast cancer.

    La Jolla, California and other locations

  • Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival

    Sorry, currently not accepting new patients, but might later

    This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

    La Jolla, California and other locations

  • The Active After Cancer Trial (AACT)

    Sorry, in progress, not accepting new patients

    This study is being done to determine whether a telephone-based counseling intervention can help survivors of breast and colorectal cancer increase their weekly physical activity. Observational evidence suggests that physical activity after breast and colorectal cancer diagnosis decreases recurrence rates. Unfortunately, many people become less active during cancer therapy, and a substantial proportion never return to pre-diagnosis levels of physical activity. This study looks to see if people who have recently finished chemotherapy for breast, colon or rectal cancer can be motivated to increase their exercise by talking to an exercise specialist over the phone. The study also looks at changes in mood, fatigue, fitness, fat distribution and weight.

    La Jolla, California and other locations

  • The Implementation and Sustainment of Digital MBC in Youth Mental Health Services

    Sorry, in progress, not accepting new patients

    This study will investigate the effects of an intervention called Leadership and Organizational Change for Implementation (LOCI), relative to implementation as usual (IAU), on clinician fidelity to, and youth service outcomes of, a well-established digital measurement-based care intervention called the Outcomes Questionnaire-Analyst in outpatient community mental health clinics.

    San Diego, California and other locations

  • TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery

    Sorry, not currently recruiting here

    This phase II trial studies how well TPIV100 and sargramostim work in treating patients with HER2 positive, stage II-III breast cancer that has residual disease after chemotherapy prior to surgery. It also studies why some HER2 positive breast cancer patients respond better to chemotherapy in combination with trastuzumab and pertuzumab. TPIV100 is a type of vaccine made from HER2 peptide that may help the body build an effective immune response to kill tumor cells that express HER2. Sargramostim increases the number of white blood cells in the body following chemotherapy for certain types of cancer and is used to alert the immune system. It is not yet known if TPIV100 and sargramostim will work better in treating patients with HER2 positive, stage II-III breast cancer.

    La Jolla, California and other locations

  • Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

    PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.

    La Jolla, California and other locations

  • Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

    Sorry, not accepting new patients

    Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

    San Diego, California and other locations

Our lead scientists for Breast Cancer research studies include .

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