Study on Tamoxifen, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy for Treating Invasive RxPONDER Breast Cancer

Program Overview

This study is testing whether hormone therapies such as tamoxifen, anastrozole, letrozole, or exemestane, with or without chemotherapy, are effective in treating invasive breast cancer that has spread to nearby tissues. Estrogen can help breast cancer cells grow, so these hormone therapies work by blocking or reducing estrogen in the body. Chemotherapy drugs work by killing cancer cells or stopping them from growing and spreading. The study aims to determine if combining these hormone therapies with chemotherapy is more effective than hormone therapy alone.

Description

The main goal of this study is to see if chemotherapy helps patients with node-positive breast cancer who have low recurrence scores, as determined by the Oncotype DX test. Secondary goals include comparing survival rates, side effects, and quality of life between those who receive chemotherapy and those who do not. The study also looks at the cost-effectiveness of using the Oncotype DX test to guide treatment decisions.

Participants are divided into two groups:

• Group 1: Receives chemotherapy followed by hormone therapy (tamoxifen or an aromatase inhibitor) for 5-10 years, unless the cancer progresses or side effects are too severe.
• Group 2: Receives hormone therapy alone for 5-10 years, unless the cancer progresses or side effects are too severe.

After treatment, participants will have follow-up visits every 3 months for the first year, every 6 months for the next 4 years, and then annually for 15 years.

Eligibility Criteria

Locations