A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

Completed · Phase 3

Conditions studied: HER2+ Metastatic Breast Cancer (MBC)

In brief

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.

Key facts

Study ID

NCT01808573

Run by

Puma Biotechnology, Inc.

People needed

621

Starts

2013-03-29

Expected to finish

2019-12-09

Last updated by the study team

2021-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Ironwood Cancer and Research Centers — Gilbert, Arizona, United States
• Ironwood Cancer and Research Centers — Mesa, Arizona, United States
• Ironwood Cancer and Research Centers — Scottsdale, Arizona, United States
• UCLA Hematology Oncology — Alhambra, California, United States
• CBCC Global Research, Inc. at Comprehensive Blood and Caner Center — Bakersfield, California, United States
• Compassionate Cancer Care Medical Group Inc. — Fountain Valley, California, United States
• St. Jude Heritage Medical Group — Fullerton, California, United States
• St. Jude Heritage Medical Group — Fullerton, California, United States
• Marin Cancer Care, Inc. — Greenbrae, California, United States
• UCLA Hematology Oncology — Irvine, California, United States
• University of California San Diego Medical Center — La Jolla, California, United States
• University of California San Diego Moores Cancer Center — La Jolla, California, United States
• Breastlink Medical Group, Inc. — Orange, California, United States
• UCLA Hematology Oncology — Pasadena, California, United States
• UCLA Hematology Oncology — Porter Ranch, California, United States
• Emad Ibrahim, MD — Redlands, California, United States
• Cancer Care Associates Medical Group, Inc — Redondo Beach, California, United States
• Compassionate Cancer Care Medical Group — Riverside, California, United States
• University of California San Diego Medical Center - Hillcrest — San Diego, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Breastlink Medical Group, Inc. — Santa Ana, California, United States
• Cancer Center of Santa Barbara Sansum Clinic — Santa Barbara, California, United States
• Central Coast Medical Oncology — Santa Maria, California, United States
• UCLA Hematology Oncology — Santa Monica, California, United States
• Ironwood Cancer and Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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