Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00915018

Run by

Puma Biotechnology, Inc.

People needed

479

Starts

2009-08-21

Expected to finish

2018-06-28

Last updated by the study team

2018-08-22

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Dublin Hematology and Oncology Care — Dublin, Georgia, United States
• Clintell — Skokie, Illinois, United States
• Presence Hematology and Oncology — Skokie, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• CHRISTUS St. Frances Cabrini Hospital — Alexandria, Louisiana, United States
• Hematology Oncology Services — Metairie, Louisiana, United States
• Park Nicollet Institute — Saint Louis Park, Minnesota, United States
• Missouri Cancer Associates — Columbia, Missouri, United States
• St. John's Medical Research Institute — Springfield, Missouri, United States
• Washington University School of Medicine Siteman Cancer Center — St Louis, Missouri, United States
• The Valley Hospital, Luckow Pavilion Office of Oncology Clinical Trials — Paramus, New Jersey, United States
• Gaston Hematology and Oncology Associates — Gastonia, North Carolina, United States
• Summa Health System Hospitals — Akron, Ohio, United States
• Warren Cancer Research Foundation — Tulsa, Oklahoma, United States
• Samaritan Hematology and Oncology Consultants — Corvallis, Oregon, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States

Full record on ClinicalTrials.gov

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