Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes

PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 31, 2000

Primary Completion Date

June 30, 2006

Study Completion Date

September 30, 2012

Conditions
Breast Cancer
Interventions
BIOLOGICAL

filgrastim

Neupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC \> 10,000/uL x1 day after the nadir cycles 1-3.

DRUG

cyclophosphamide

cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3

DRUG

doxorubicin hydrochloride

Patients then receive doxorubicin IV on day 1.

DRUG

paclitaxel

Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3

DRUG

tamoxifen citrate

tamoxifen at a dose of 20 mg daily for 5 years after chemotherapy is completed

PROCEDURE

adjuvant therapy

Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.

RADIATION

radiation therapy

Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.

Trial Locations (3)

44060

UH-LUICC, Mentor

44122

UH-Chagrin Highlands, Orange

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

NCT00007904 - Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes | Biotech Hunter | Biotech Hunter