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

Completed · Phase 2

Conditions studied: Advanced Breast Cancer, Breast Cancer

In brief

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.

Key facts

Study ID

NCT00777101

Run by

Puma Biotechnology, Inc.

People needed

233

Starts

2009-02-04

Expected to finish

2018-06-03

Last updated by the study team

2018-08-09

Who can join

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

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Southwest Cancer Care — Murrieta, California, United States
• UC Irvine Medical Center — Orange, California, United States
• Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center — Palm Springs, California, United States
• Redwood Regional Medical Group, Inc. — Santa Rosa, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Hematology Oncology Associates, P.C. — Stamford, Connecticut, United States
• Palm Beach Institute of Hematology & Oncology — Boynton Beach, Florida, United States
• Robert R. Carroll, MD, PA — Gainesville, Florida, United States
• University of Florida — Jacksonville, Florida, United States
• Hematology Oncology Associates — Loxahatchee Groves, Florida, United States
• Mercy Research Institute — Miami, Florida, United States
• Cancer Centers of Florida — Orlando, Florida, United States
• Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
• Cancer Care Specialists Of Central Illinois — Decatur, Illinois, United States
• Oncology Specialists, SC — Park Ridge, Illinois, United States
• Midwestern Regional Medical Center — Zion, Illinois, United States
• Central Indiana Cancer Centers — Fishers, Indiana, United States
• Hematology Oncology of Indiana — Indianapolis, Indiana, United States
• Floyd Memorial Cancer Center of Indiana — New Albany, Indiana, United States
• Ashland-Bellefonte Cancer Center — Ashland, Kentucky, United States
• Owsley Brown Frazier Cancer Center (OBFCC) — Louisville, Kentucky, United States
• Purchase Cancer Group — Paducah, Kentucky, United States
• Missouri Cancer Associates — Columbia, Missouri, United States
• Capitol Comprehensive Cancer Care Clinic — Jefferson City, Missouri, United States
• Arizona Oncology Associates HOPE — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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