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Hormone Therapy in Treating Postmenopausal Women With Receptor-Positive Breast Cancer

NCT00002646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2012-01-05

No results posted yet for this study

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining chemotherapy with hormone therapy may kill more tumor cells. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may be an effective way to prevent the recurrence of breast cancer. It is not yet known whether tamoxifen plus fenretinide is more effective than tamoxifen alone for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen plus fenretinide with tamoxifen alone in treating postmenopausal women who have stage II or stage III breast cancer that is estrogen receptor positive and/or progesterone receptor positive.

Conditions

Interventions

DRUG

fenretinide

DRUG

tamoxifen citrate

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Melody A. Cobleigh, MD · Rush University Medical Center

  • George Thomas Budd, MD · The Cleveland Clinic

  • Mark L. Graham, MD · UNC Lineberger Comprehensive Cancer Center

  • James N. Ingle, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-10-31
Primary Completion
2004-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00002646 on ClinicalTrials.gov