Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

Details

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. Patients will be randomized in a 1:1 ratio to one of the following treatment arms:

  • Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m2 daily, 750 mg/m2 twice daily [BID])

  • Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m2 daily, 1000 mg/m2 BID)

Patients will receive either neratinib plus capecitabine combination or lapatinib plus capecitabine combination until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.

Keywords

HER2+ Metastatic Breast Cancer (MBC) Neratinib Nerlynx Breast Neoplasms Capecitabine Lapatinib neratinib plus capecitabine lapatinib plus capecitabine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Aged ≥18 years at signing of informed consent.
  • Histologically confirmed MBC, current stage IV.
  • Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+,with confirmatory fluorescence in situ hybridization (FISH) +.
  • Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.

You CAN'T join if...

  • Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Locations

  • University of California San Diego Medical Center
    La Jolla California 92037 United States
  • University of California San Diego
    La Jolla California 92093-0698 United States
  • University of California San Diego Medical Center
    San Diego California 92103 United States
  • Sharp Memorial Hospital
    San Diego California 92123 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Puma Biotechnology, Inc.
ID
NCT01808573
Phase
Phase 3
Study Type
Interventional
Last Updated