A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Puma Biotechnology, Inc.
- Enrollment
- 479
- Locations
- 194
- Primary Endpoint
- Progression-Free Survival
Study Overview
Brief Summary
This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ErbB-2 positive locally recurrent or metastatic breast cancer
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •Measurable disease
- •Availability of tumor tissue for HER2 status confirmation
Exclusion Criteria
- •Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
- •Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
- •Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
- •History of heart disease
- •History of gastrointestinal disease
Arms & Interventions
neratinib plus paclitaxel
Intervention: Neratinib (Drug)
neratinib plus paclitaxel
Intervention: Paclitaxel (Drug)
trastuzumab plus paclitaxel
Intervention: Trastuzumab (Drug)
trastuzumab plus paclitaxel
Intervention: Paclitaxel (Drug)
Outcomes
Primary Outcomes
Progression-Free Survival
Time Frame: From randomization to disease progression or death, assessed up to 5.3 years
Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
Secondary Outcomes
- Objective Response Rate(From randomization to disease progression or last tumor assessment, assessed up to 5.3 years)
- Duration of Response(From first response to first PD or death, assessed up to 5.3 years after first subject randomized)
- Clinical Benefit Rate(From randomization to disease progression or death, assessed up to 5.3 years)
- Symptomatic or Progressive Central Nervous System (CNS) Lesions(From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years)