CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,411 enrolled
Drug / intervention
Cyclophosphamide +3 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/NCT00002707
NCT00002707Phase 3Completed

A RANDOMIZED TRIAL COMPARING PREOPERATIVE DOXORUBICIN (ADRIAMYCIN)/CYCLOPHOSPHAMIDE (AC) TO PREOPERATIVE AC FOLLOWED BY PREOPERATIVE DOCETAXEL (TAXOTERE) AND TO PREOPERATIVE AC FOLLOWED BY POSTOPERATIVE DOCETAXEL IN PATIENTS WITH OPERABLE CARCINOMA OF THE BREAST

NSABP Foundation Inc·interventional·Posted May 21, 2004·Updated Feb 3, 2010

In Brief

A Phase 3 clinical trial evaluating Cyclophosphamide, Docetaxel, and 2 other interventions for Breast Cancer. Completed, enrolled 2,411 participants across 145 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if chemotherapy given before surgery is more effective with or without docetaxel given before or after surgery for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy using doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage II or stage III breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 21, 2004
Enrollment StartDec 1, 1995
Primary CompletionJun 1, 2002
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 22.1 years ago

Interventions

Cyclophosphamidedrug

600 mg/m2 IV every 21 days for 4 cycles

Docetaxeldrug

100 mg/m2 IV every 21 days for 4 cycles

Doxorubicindrug

60 mg/m2 IV every 21 days fo 4 cycles

Tamoxifendrug

20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle