S9630, Medroxyprogesterone in Treating Women With Breast Cancer

NCT00002920 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2012-10-31

No results posted yet for this study

Summary

RATIONALE: It is not yet known whether medroxyprogesterone is effective in preventing endometrial disorder in patients with breast cancer who are taking tamoxifen.

PURPOSE: Randomized phase III trial to study the effectiveness of medroxyprogesterone in preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ, lobular carcinoma in situ, Paget's disease of the nipple, stage I breast cancer, or stage II breast cancer and who are taking tamoxifen.

Conditions

Interventions

DRUG

medroxyprogesterone

DRUG

tamoxifen citrate

PROCEDURE

adjuvant therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Cancer and Leukemia Group B

    collaborator NETWORK
  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Ronald K. Potkul, MD · Loyola University

  • Barbara L. Smith, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-03-31
Primary Completion
2006-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT00002920 on ClinicalTrials.gov