OncRef

Clinical Trial: NCT01272037

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-01

Study Overview

Brief 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

Conditions

Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma, Synchronous Bilateral Breast Carcinoma

Intervention / Treatment

  • Drug: Anastrozole
  • Drug: Exemestane
  • Other: Laboratory Biomarker Analysis
  • Drug: Letrozole
  • Other: Quality-of-Life Assessment
  • Drug: Systemic Chemotherapy
  • Drug: Tamoxifen Citrate

Other Study ID Numbers

  • NCI-2011-02623
  • NCI-2011-02623
  • S12-03603
  • CDR0000692475
  • PS1007_A11PAMDREVW01
  • SWOG-S1007
  • S1007
  • S1007
  • U10CA032102
  • U10CA180830
  • U10CA180888

Start Date (Actual)

2011-02-28

Primary Completion Date (Actual)

2023-02-01

Study Completion Date (Estimated)

2027-01-08

Enrollment (Actual)

5018

Study Type

Interventional

Phase

Phase 3