Summary

for people ages 18–69 (full criteria)
at La Jolla, California and other locations
study started

Description

Summary

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) 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.

Official Title

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

Details

This is a randomized double-blind placebo-controlled phase III trial of aspirin (300 mg daily) in early stage node-positive HER2 negative breast cancer patients. Patients will be randomized 1:1 within stratum defined by: Hormone Receptor status (HR positive vs HR negative), body mass index (<30 vs ≥ 30 kg/m2) and stage (Stage II vs III).

The primary objective of this trial is to compare the effect of aspirin versus placebo upon invasive disease free survival (iDFS).

Primary objective To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage node-positive HER2 negative breast cancer patients.

Secondary objectives

  1. To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon:
  2. Distant disease-free survival
  3. Overall survival
  4. Cardiovascular disease (see Section11.3)
  5. To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients.
  6. To assess adherence to aspirin and placebo among early stage node-positive HER2 negative breast cancer patients.
  7. To bank tumor and germline deoxyribonucleic acid (DNA), plasma and urine collected at baseline and sequential plasma and urine collected 2 years later for future measurement of inflammatory markers.
  8. To determine if there are subgroups of participants characterized by lifestyle factors associates with greater inflammation for whom there is greater benefit of aspirin versus placebo upon iDFS.

Patients are followed up to 10 years after study enrollment.

Keywords

Node Positive HER2 Negative Breast Cancer Breast Neoplasms Aspirin

Eligibility

For people ages 18–69

  • Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma and high risk node negative (defined as estrogen receptor [ER] and progesterone receptor [PR] negative and tumor size > 2 cm) within one year of diagnosis and free of recurrence; patients with pN1mic are eligible; if neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility; histologic documentation of node positivity is required; bilateral breast cancers are allowed, as long as both cancers are HER2 negative and at least one of the cancers meets eligibility
  • Any ER/progesterone receptor (PgR) status allowed
  • Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed; the last dose of chemotherapy or radiation therapy must be at least 30 days prior to study registration; concurrent hormonal therapy will be allowed
  • Regular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days prior to study entry and throughout the study period; participants will be encouraged to use acetaminophen for minor pain and fever
  • Patients must be enrolled within 1 year after diagnosis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention; for patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed
  • No history of gastrointestinal bleeding (GI) bleeding requiring a blood transfusion,endoscopic or operative intervention
  • No history of any prior stroke (hemorrhagic or ischemic)
  • No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel,oral direct thrombin inhibitors, or direct factor XA inhibitors
  • No history of atrial fibrillation or myocardial infarction
  • No history of grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis)
  • No chronic (duration > 30 days) daily use of oral steroids
  • No known allergy to aspirin
  • No prior malignancy of any type (including ductal breast carcinoma in situ [DCIS])within the past 5 years except for current diagnosis of breast cancer, and any prior diagnosis of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; patients with a prior history of breast cancer greater than 5 years from study screening may participate in this study
  • Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla, California, 92093, United States
  • Sharp Memorial Hospital accepting new patients
    San Diego, California, 92123, United States
  • Kaiser Permanente-San Diego Mission accepting new patients
    San Diego, California, 92108, United States
  • Kaiser Permanente-San Diego Zion accepting new patients
    San Diego, California, 92120, United States
  • Kaiser Permanente-San Marcos accepting new patients
    San Marcos, California, 92078, United States
  • Kaiser Permanente-Irvine accepting new patients
    Irvine, California, 92618, United States
  • UC Irvine Health Cancer Center-Newport accepting new patients
    Costa Mesa, California, 92627, United States
  • Saint Joseph Hospital - Orange accepting new patients
    Orange, California, 92868, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center accepting new patients
    Orange, California, 92868, United States
  • Kaiser Permanente-Anaheim accepting new patients
    Anaheim, California, 92807, United States
  • Kaiser Permanente-Riverside accepting new patients
    Riverside, California, 92505, United States
  • Eisenhower Medical Center accepting new patients
    Rancho Mirage, California, 92270, United States
  • Kaiser Permanente-Ontario accepting new patients
    Ontario, California, 91761, United States
  • Kaiser Permanente-Fontana accepting new patients
    Fontana, California, 92335, United States
  • Kaiser Permanente-Bellflower accepting new patients
    Bellflower, California, 90706, United States
  • Kaiser Permanente - Harbor City accepting new patients
    Harbor City, California, 90710, United States
  • Kaiser Permanente-Baldwin Park accepting new patients
    Baldwin Park, California, 91706, United States
  • Huntington Memorial Hospital accepting new patients
    Pasadena, California, 91105, United States
  • Kaiser Permanente-Cadillac accepting new patients
    Los Angeles, California, 90034, United States
  • Kaiser Permanente Los Angeles Medical Center accepting new patients
    Los Angeles, California, 90027, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center accepting new patients
    Burbank, California, 91505, United States
  • Kaiser Permanente - Panorama City accepting new patients
    Panorama City, California, 91402, United States
  • Kaiser Permanente-Woodland Hills accepting new patients
    Woodland Hills, California, 91367, United States
  • AIS Cancer Center at San Joaquin Community Hospital accepting new patients
    Bakersfield, California, 93301, United States
  • Hope Cancer Care of Nevada-Pahrump accepting new patients
    Pahrump, Nevada, 89048, United States
  • PCR Oncology accepting new patients
    Arroyo Grande, California, 93420, United States
  • Cancer and Blood Specialists-Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Comprehensive Cancer Centers of Nevada - Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Comprehensive Cancer Centers of Nevada-Horizon Ridge accepting new patients
    Henderson, Nevada, 89052, United States
  • Las Vegas Cancer Center-Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Nevada Cancer Specialists-Saint Rose accepting new patients
    Henderson, Nevada, 89052, United States
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin accepting new patients
    Las Vegas, Nevada, 89113, United States
  • Las Vegas Cancer Center-Medical Center accepting new patients
    Las Vegas, Nevada, 89148-2405, United States
  • 21st Century Oncology-Fort Apache accepting new patients
    Las Vegas, Nevada, 89148, United States
  • Comprehensive Cancer Centers of Nevada accepting new patients
    Las Vegas, Nevada, 89148, United States
  • Nevada Cancer Specialists-Fort Apache accepting new patients
    Las Vegas, Nevada, 89148, United States
  • 21st Century Oncology-Henderson accepting new patients
    Henderson, Nevada, 89074, United States
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson accepting new patients
    Henderson, Nevada, 89074, United States
  • Radiation Oncology Centers of Nevada Southeast accepting new patients
    Las Vegas, Nevada, 89119, United States
  • Comprehensive Cancer Centers of Nevada-Summerlin accepting new patients
    Las Vegas, Nevada, 89144, United States
  • Summerlin Hospital Medical Center accepting new patients
    Las Vegas, Nevada, 89144, United States
  • Desert West Surgery accepting new patients
    Las Vegas, Nevada, 89102, United States
  • Nevada Cancer Specialists?Oakey accepting new patients
    Las Vegas, Nevada, 89102, United States
  • University Medical Center of Southern Nevada accepting new patients
    Las Vegas, Nevada, 89102, United States
  • 21st Century Oncology accepting new patients
    Las Vegas, Nevada, 89109, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway accepting new patients
    Las Vegas, Nevada, 89109, United States
  • Sunrise Hospital and Medical Center in progress, not accepting new patients
    Las Vegas, Nevada, 89109, United States
  • Comprehensive Cancer Centers of Nevada - Central Valley accepting new patients
    Las Vegas, Nevada, 89169, United States
  • University Cancer Center accepting new patients
    Las Vegas, Nevada, 89169, United States
  • Cancer Therapy and Integrative Medicine accepting new patients
    Las Vegas, Nevada, 89121, United States
  • 21st Century Oncology-Vegas Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Ann M Wierman MD LTD accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Cancer and Blood Specialists-Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Comprehensive Cancer Centers of Nevada - Northwest accepting new patients
    Las Vegas, Nevada, 89128, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Nevada Cancer Specialists-Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Cancer and Blood Specialists-Shadow accepting new patients
    Las Vegas, Nevada, 89106, United States
  • Radiation Oncology Centers of Nevada Central accepting new patients
    Las Vegas, Nevada, 89106, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills accepting new patients
    Las Vegas, Nevada, 89149, United States
  • Arizona Center for Cancer Care-Surprise accepting new patients
    Surprise, Arizona, 85374, United States
  • Arizona Center for Cancer Care-Peoria accepting new patients
    Peoria, Arizona, 85381, United States
  • Virginia G Piper Cancer Care-Glendale accepting new patients
    Glendale, Arizona, 85306, United States

Details

Status
accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT02927249
Phase
Phase 3
Lead Scientist
Erin Roesch
Study Type
Interventional
Last Updated
May 4, 2018