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Hormone Therapy and Chemotherapy in Treating Perimenopausal or Postmenopausal Women With Node-Positive Breast Cancer

NCT00002529 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2013-04-04

No results posted yet for this study

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the uptake of estrogen. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy during or after combination chemotherapy or hormone therapy alone in treating perimenopausal or postmenopausal women who have stage II or stage IIIA breast cancer.

Conditions

Interventions

DRUG

cyclophosphamide

cyclophosphamide 600 mg/m2 i.v. day 1) every 21 days

DRUG

doxorubicin hydrochloride

doxorubicin 60 mg/m2 i.v. day 1) every 21 days, intravenous.

DRUG

epirubicin hydrochloride

epirubicin 90 mg/m2 i.v. day 1) every 21 days, intravenous.

DRUG

tamoxifen citrate

Tamoxifen 20 mg daily.

DRUG

toremifene

Toremifene 60 mg daily.

Sponsors & Collaborators

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Edda Simoncini, MD · Spedali Civili di Brescia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-05-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Australia
  • Italy
  • New Zealand
  • Slovenia
  • South Africa
  • Sweden
  • 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 NCT00002529 on ClinicalTrials.gov