Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00915018
- Lead Sponsor
- Puma Biotechnology, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 479
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description neratinib plus paclitaxel Neratinib - trastuzumab plus paclitaxel Trastuzumab - neratinib plus paclitaxel Paclitaxel - trastuzumab plus paclitaxel Paclitaxel -
- Primary Outcome Measures
Name Time Method Progression-Free Survival 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 Outcome Measures
Name Time Method Objective Response Rate From randomization to disease progression or last tumor assessment, assessed up to 5.3 years Defined as the percentage of subjects who achieved confirmed tumor response (complete or partial response) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-Progressive Disease for non-target lesions, and no new lesions.
Duration of Response From first response to first PD or death, assessed up to 5.3 years after first subject randomized Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, disease progression (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Clinical Benefit Rate From randomization to disease progression or death, assessed up to 5.3 years Defined as the proportion of patients who achieved overall tumor response (CR or PR) or SD for at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Symptomatic or Progressive Central Nervous System (CNS) Lesions From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years Defined as the time interval from the date of randomization until the first date of CNS symptoms, the imaging examination shows CNS progression or is censored at the last assessable evaluation on study or prior to new anti-cancer therapy, if applicable.
If median time to Symptomatic or Progressive CNS Lesions is not estimable, cumulative incidence will be reported instead.
Trial Locations
- Locations (194)
Ventura County Hematology-Oncology Specialists
🇺🇸Oxnard, California, United States
Redwood Regional Medical Group
🇺🇸Santa Rosa, California, United States
Cancer Center of Central Connecticut
🇺🇸Plainville, Connecticut, United States
Palm Beach Institute of Hematology and Oncology
🇺🇸Boynton Beach, Florida, United States
North Broward Medical Center Cancer Center
🇺🇸Deerfield Beach, Florida, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Mid Florida Cancer Centers
🇺🇸Orange City, Florida, United States
Florida Cancer Research Institute
🇺🇸Plantation, Florida, United States
Hematology Oncology Associates of Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Phoebe Cancer Center
🇺🇸Albany, Georgia, United States
Scroll for more (184 remaining)Ventura County Hematology-Oncology Specialists🇺🇸Oxnard, California, United States