MedTrace Logo

Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

NCT00311636 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2013-06-26

No results posted yet for this study

Summary

RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening.

PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early menopause in premenopausal women who are receiving chemotherapy for stage I, stage II, or stage III breast cancer that has been removed by surgery.

Conditions

Interventions

DRUG

cyclophosphamide

DRUG

docetaxel

DRUG

doxorubicin hydrochloride

DRUG

epirubicin hydrochloride

DRUG

fluorouracil

DRUG

methotrexate

DRUG

paclitaxel

DRUG

triptorelin

PROCEDURE

adjuvant therapy

Sponsors & Collaborators

  • Gruppo Italiano Mammella (GIM)

    lead OTHER

Principal Investigators

  • Lucia Del Mastro, MD · IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

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

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2008-01-31
Completion
2008-04-30

Countries

  • Italy

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 NCT00311636 on ClinicalTrials.gov