Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Puma Biotechnology

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Advanced Breast Cancer

Treatments: Drug: Neratinib; Drug: Capecitabine; Drug: Lapatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777101

3144A2-3003 / B1891003

Details and patient eligibility

About

This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

Enrollment: 233 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
• Prior use of Herceptin (trastuzumab), and a taxane
• Adequate cardiac and renal function

Exclusion criteria

• More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
• Bone as the only site of disease
• Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
• Significant gastrointestinal disorder with diarrhea as major symptom

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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233 participants in 2 patient groups

Neratinib

Experimental group

Treatment:

Drug: Neratinib

Lapatinib plus Capecitabine

Active Comparator group

Treatment:

Drug: Lapatinib

Drug: Capecitabine