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Chemotherapy Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

NCT00003953 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2013-01-28

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.

PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel followed by surgery in treating women who have stage II or stage III breast cancer.

Conditions

Interventions

BIOLOGICAL

filgrastim

Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each 2 week course.

DRUG

CMF regimen

Stratum I and II: receive cyclophosphamide, methotrexate, and fluorouracil (CMF) for 4 courses

DRUG

docetaxel

Docetaxel IV over 1 hour on days 43, 57, and 71.

DRUG

doxorubicin hydrochloride

Doxorubicin IV on days 1, 15, and 29.

DRUG

tamoxifen citrate

Patients with positive estrogen or progesterone receptors receive oral tamoxifen daily for 5 years.

PROCEDURE

autologous bone marrow transplantation

Stratum III:may receive high dose chemotherapy with stem cell support

PROCEDURE

surgical procedure

Fourteen to 21 days following preoperative chemotherapy, patients undergo a radical, modified radical, or breast sparing surgery plus axillary lymph node dissection.

RADIATION

radiation therapy

Radiotherapy is administered 5 days a week for 5.5 weeks.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Brenda W. Cooper, MD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-02-28
Primary Completion
2001-11-30
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00003953 on ClinicalTrials.gov