Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at Costa Mesa, California and other locations
Dates
study started
completion around

Description

Summary

This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.

Official Title

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer

Details

Keywords

Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma, Synchronous Bilateral Breast Carcinoma, Carcinoma, Breast Neoplasms, Carcinoma in Situ, Ductal Carcinoma, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Tamoxifen, Letrozole, Anastrozole, Exemestane, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Systemic Chemotherapy, Tamoxifen Citrate, chemotherapy and endocrine therapy, endocrine therapy

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT01272037
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 5018 people participating
Last Updated