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

NCT01272037 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5018

Last updated 2026-05-04

Study results available
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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.

Conditions

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

Interventions

DRUG

Anastrozole

Given PO

DRUG

Exemestane

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Letrozole

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies (closed as of 12/1/12)

DRUG

Systemic Chemotherapy

Given IV

DRUG

Tamoxifen Citrate

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kevin M Kalinsky · SWOG Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2023-02-01
Completion
2027-01-08

Countries

  • United States
  • Canada
  • Colombia
  • France
  • Ireland
  • Mexico
  • Puerto Rico
  • Saudi Arabia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01272037 on ClinicalTrials.gov