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

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

February 28, 1999

Primary Completion Date

November 30, 2001

Study Completion Date

January 31, 2013

Conditions
Breast Cancer
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.

Trial Locations (2)

44109

Metro Health Medical Center, Cleveland

44106-5065

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER