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Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

NCT00310180 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10273

Last updated 2026-04-24

Study results available
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Summary

This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or 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. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

Conditions

  • Breast Adenocarcinoma
  • Hormone Receptor Positive
  • Stage IA Breast Cancer AJCC v7
  • Stage IB Breast Cancer AJCC v7
  • Stage IIA Breast Cancer AJCC v6 and v7
  • Stage IIB Breast Cancer AJCC v6 and v7
  • Stage IIIB Breast Cancer AJCC v7

Interventions

RADIATION

Radiation Therapy

Undergo radiation therapy or partial breast irradiation

DRUG

Tamoxifen Citrate

Given PO

DRUG

Exemestane

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Letrozole

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Anastrozole

Given PO

Sponsors & Collaborators

  • American College of Surgeons

    collaborator OTHER

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • NSABP Foundation Inc

    collaborator NETWORK

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    collaborator NETWORK

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Joseph A Sparano · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-07
Primary Completion
2018-03-02
Completion
2030-09-30

Countries

  • United States
  • Australia
  • Canada
  • Ireland
  • New Zealand
  • Peru
  • Puerto Rico
  • United Kingdom

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 NCT00310180 on ClinicalTrials.gov