At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 5,351 enrolled

Drug / intervention

cyclophosphamide +2 moredrug

Likely dose

Arm 1 (AC-T): Doxorubicin 60 mg/m² IV q21d × 4 cycles, then Docetaxel 100 mg/m² IV q21d × 4 cycles, with Cyclophosphamide 600 mg/m² IV q21d × 4 cycles; Arm 2 (AT): Doxorubicin 50 mg/m² IV q21d × 4 cycles + Docetaxel 75 mg/m² IV q21d × 4 cycles; Arm 3 (ATC): Doxorubicin 50 mg/m² IV q21d × 4 cycles + Docetaxel 75 mg/m² IV q21d × 4 cycles + Cyclophosphamide 500 mg/m² IV q21d × 4 cyclesAI-extracted

Key inclusion· 8

✓Histologically confirmed invasive adenocarcinoma of the breast, Stage I–IIIA (cT1–3, N0–1, M0)
✓At least one axillary lymph node positive for tumor on histologic examination
✓Prior total mastectomy with axillary dissection OR lumpectomy with axillary dissection and clear margins
✓Age ≥18 years, female

Key exclusion· 10

✕Metastatic disease (skeletal pain allowed if bone scan negative)
✕Bilateral breast malignancy or contralateral breast mass unless histologically proven benign
✕Suspicious palpable nodes in contralateral axilla or palpable supraclavicular/infraclavicular nodes unless biopsy proves no tumor involvement
✕N2 disease (fixed ipsilateral lymph nodes) or positive nonaxillary lymph nodes

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

Search/NCT00003782

NCT00003782Phase 3Completed

Compare CT.gov

A Three-Arm Randomized Trial to Compare Adjuvant Adriamycin and Cyclophosphamide Followed by Taxotere (AC-T); Adriamycin and Taxotere (AT); and Adriamycin, Taxotere, and Cyclophosphamide (ATC) in Breast Cancer Patients With Positive Axillary Lymph Nodes

NSABP Foundation Inc·interventional·Posted Jan 27, 2003·Updated Mar 21, 2024

In Brief

A Phase 3 clinical trial evaluating cyclophosphamide, docetaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 5,351 participants across 157 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. Giving combination chemotherapy after surgery may kill any tumor cells remaining following surgery. It is not yet known which regimen of combination chemotherapy is more effective in treating breast cancer with positive axillary lymph nodes. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating women who have undergone surgery for stage I, stage II, or stage IIIA breast cancer with positive axillary lymph nodes.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer

CountriesCanada, United States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished

19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 1999

First PostedJan 2003

Primary CompletionDec 2008

Study CompletionDec 2012

TodayJul 2026

First PostedJan 27, 2003

Enrollment StartMar 1, 1999

Primary CompletionDec 1, 2008

Study CompletionDec 1, 2012

TodayJul 1, 2026

Enrollment to primary: 9.8 yearsPosted 23.4 years ago

Interventions

cyclophosphamidedrug

Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles

docetaxeldrug

Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles

doxorubicindrug

Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles