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Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer

NCT00429403 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2016-05-09

Study results available
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Summary

Primary Objective:

* To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses.

Secondary Objectives:

* To determine the incidence of pregnancy and the effect for participants' quality of life (QOL) after chemotherapy.
* To determine the overall survival and disease-free survival times of study participants.

Conditions

Interventions

DRUG

Goserelin

3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Naoto Ueno, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
46 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States
  • Japan

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 NCT00429403 on ClinicalTrials.gov