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S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

NCT00068601 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2019-12-30

Study results available
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Summary

RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer.

PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.

Conditions

Interventions

DRUG

cyclophosphamide

Part of planned chemotherapy regimen

DRUG

goserelin acetate

Given subcutaneously

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • ETOP IBCSG Partners Foundation

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Halle C Moore, MD · The Cleveland Clinic

  • Kathy S. Albain, MD · Loyola University

  • Silvana Martino, DO · Saint John's Cancer Institute

  • Ann H. Partridge, MD, MPH · Dana-Farber Cancer Institute

  • Lori J. Goldstein, MD · Fox Chase Cancer Center

  • Kelly-Anne Phillips · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2014-01-31
Completion
2016-09-30

Countries

  • Australia
  • Belgium
  • Hungary
  • Italy
  • New Zealand
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
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 NCT00068601 on ClinicalTrials.gov