Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Key facts

Study ID

NCT00878709

Run by

Puma Biotechnology, Inc.

People needed

2840

Starts

2009-07-09

Expected to finish

2019-10-04

Last updated by the study team

2021-06-11

Who can join

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

You may qualify if…

• Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
• Been treated for early breast cancer with standard of care duration of trastuzumab.
• Could have been treated neoadjuvantly but have not reached pathologic complete response.

You may not qualify if…

• Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
• History of heart disease.
• Corrected QT (QTc) interval >0.45 seconds
• History of gastrointestinal disease with diarrhea as the major symptom.

Where it is running

• Birmingham Hematology and Oncology Associates, LLC — Birmingham, Alabama, United States
• Arizona Oncology Associates, PC - HAL — Phoenix, Arizona, United States
• Arizona Oncology Associates, PC - NAHOA — Sedona, Arizona, United States
• Arizona Oncology Associates — Tucson, Arizona, United States
• Arizona Cancer Center — Tucson, Arizona, United States
• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Cedars-Sinai Medical Group — Beverly Hills, California, United States
• Ronald Yanagihara, M.D. — Gilroy, California, United States
• Glendale Adventist Medical Center Cancer Services — Glendale, California, United States
• California Cancer Care — Greenbrae, California, United States
• Beaver Medical Group, L.P. — Highland, California, United States
• Breastlink Medical Group — Long Beach, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Facey Medical Group — Mission Hills, California, United States
• Gynecologic Oncology Associates — Newport Beach, California, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Desert Hematology Oncology Medical Group, Inc — Rancho Mirage, California, United States
• Helen Diller Family University of California San Francisco Comprehensive Cancer Center — San Francisco, California, United States
• San Francisco Oncology Associates — San Francisco, California, United States
• Redwood Regional Medical Group — Santa Rosa, California, United States
• The Cancer Prevention and Treatment Center — Soquel, California, United States
• Cancer Center of Central Connecticut — Southington, Connecticut, United States
• Hematology Oncology, PC — Stamford, Connecticut, United States
• Connecticut Oncology and Hematology — Torrington, Connecticut, United States
• Anniston Oncology — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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