CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,894 enrolled
Drug / intervention
Cyclophosphamide +4 moredrug
Likely dose
Three regimens: (1) TAC: docetaxel 75 mg/m² IV + doxorubicin 50 mg/m² IV + cyclophosphamide 500 mg/m² IV every 21 days for 6 cycles; (2) Dose-dense AC→P: doxorubicin 60 mg/m² IV + cyclophosphamide 600 mg/m² IV every 14 days for 4 cycles, then paclitaxel 175 mg/m² IV every 14 days for 4 cycles; (3) Dose-dense AC→PG: doxorubicin 60 mg/m² IV + cyclophosphamide 600 mg/m² IV every 14 days for 4 cycles, then paclitaxel 175 mg/m² IV + gemcitabine 2000 mg/m² IV every 14 days for 4 cyclesAI-extracted
Key inclusion· 9
  • ✓Node-positive breast cancer: pathologic staging pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b (only if microscopic internal mammary node involvement by sentinel dissection with >3 positive axillary nodes)
  • ✓Invasive carcinoma of the breast on histologic examination
  • ✓Primary tumor T1-3 by clinical and pathologic evaluation
  • ✓Zubrod performance status 0 or 1 with life expectancy ≥10 years
Key exclusion· 10
  • ✕HER2-positive disease (IHC 3+ or FISH positive for gene amplification)
  • ✕Primary tumor staged as T4 for any reason
  • ✕Prior history of breast cancer, including DCIS (LCIS eligible)
  • ✕Prior therapy with anthracyclines or taxanes for any malignancy

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

Search/NCT00093795
NCT00093795Phase 3Completed
CompareCT.gov

A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed By DD Paclitaxel (DD AC→P); DD AC Followed By DD Paclitaxel Plus Gemcitabine (DD AC→PG)

NSABP Foundation Inc·interventional·Posted Oct 8, 2004·Updated Jan 11, 2018

In Brief

A Phase 3 clinical trial evaluating Cyclophosphamide, Docetaxel, and 3 other interventions for Breast Cancer. Completed, enrolled 4,894 participants across 12 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin , cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase III trial is studying three different combination chemotherapy regimens and comparing how well they work in treating women who have undergone surgery for node-positive breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2004
Enrollment StartOct 1, 2004
Primary CompletionMar 1, 2012
Study CompletionJun 1, 2016
TodayJul 1, 2026
Enrollment to primary: 7.4 yearsPosted 21.7 years ago

Interventions

Cyclophosphamidedrug

Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles

Docetaxeldrug

75 mg/m2 IV every 21 days for 6 cycles

Gemcitabinedrug

2000 mg/m2 IV every 14 days for 4 cycles

Paclitaxeldrug

175 mg/m2 IV every 14 days for 4 cycles

Doxorubicindrug

Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles