CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 452 enrolled
Drug / intervention
cyclophosphamide +4 moredrug
Likely dose
cyclophosphamide 600 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00002529
NCT00002529Phase 3Completed

Adjuvant Therapy for Post/Perimenopausal Patients With Node Positive Breast Cancer Who Are Suitable for Endocrine Therapy Alone.

ETOP IBCSG Partners Foundation·interventional·Posted Jul 29, 2004·Updated Apr 4, 2013

In Brief

A Phase 3 clinical trial evaluating cyclophosphamide, doxorubicin hydrochloride, and 3 other interventions for Breast Cancer. Completed, enrolled 452 participants across 20 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Italy, New Zealand, Slovenia, South Africa, Sweden, Switzerland
Collaborators--

Timeline

Phase 3CompletedFinished
19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2004
Enrollment StartMay 1, 1993
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 17.3 yearsPosted 21.9 years ago

Interventions

cyclophosphamidedrug

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

doxorubicin hydrochloridedrug

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

epirubicin hydrochloridedrug

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

tamoxifen citratedrug

Tamoxifen 20 mg daily.

toremifenedrug

Toremifene 60 mg daily.