Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed

NCT00002707 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2411

Last updated 2010-02-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cyclophosphamide

600 mg/m2 IV every 21 days for 4 cycles

DRUG

Docetaxel

100 mg/m2 IV every 21 days for 4 cycles

DRUG

Doxorubicin

60 mg/m2 IV every 21 days fo 4 cycles

DRUG

Tamoxifen

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • NSABP Foundation Inc

    lead NETWORK

Principal Investigators

  • Harry D. Bear, MD, PhD · Massey Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-12-31
Primary Completion
2002-06-30
Completion
2010-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT00002707 on ClinicalTrials.gov