Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer

OBJECTIVES: I. Compare engraftment rates using G-CSF primed autologous bone marrow vs PBCP as
hematopoietic support following high dose CTCb for patients with poor prognosis breast
cancer. II. Compare the complications of these two methods of hematopoietic progenitor cell
collections. III. Compare Stage IV patients with bone or bone marrow involvement (assigned to
PBPC collections) with Stage IV patients randomized to PBPC collections relative to the
number of leukaphereses needed to collect the required number of progenitor cells as well as
assess engraftment rates between these two groups. IV. Assess the response to high dose CTCb
in this group of patients.

OUTLINE: All patients will receive G-CSF priming therapy for 5 consecutive days. Patients
will then be randomized into two treatment arms: Arm 1 consists of autologous PBPC collection
Arm 2 consists of autologous bone marrow collection Within 2 weeks after progenitor cell
collection, all patients will receive high dose CTCb therapy by continuous infusion for 5
days, followed by autologous hematopoietic progenitor cell infusion at least three days
later. G-CSF will also be given after infusion until ANC count is over 5,000 or over 1,000
for 3 consecutive days.

PROJECTED ACCRUAL: 66 patients will be accrued at a rate of 24 per year.

DISEASE CHARACTERISTICS: Histologically confirmed Stage IIIB and IV adenocarcinoma of the
breast Stage II-IIIA adenocarcinoma of the breast with poor risk features (including poorly
differentiated histology, high mitotic rate, hormone receptor negative, high S phase) with
at least three involved axillary lymph nodes, estimated five year relapse free survival
rate less than 50%, and does not qualify for higher priority protocol treatments No central
nervous system involvement

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Karnofsky 80-100% Life
expectancy: Greater than 2 months Hematopoietic: Platelet count greater than 75,000/mm3
Neutrophils greater than 1500/mm3 Hepatic: Serum bilirubin, alkaline phosphatase, and SGOT
or SGPT less than 3 times upper limit of normal, unless due to disease Renal: Serum
creatinine less than 1.5 times upper limit of normal Creatinine clearance at least 60
mL.min Cardiovascular: Ventricular ejection fraction at least 45% No uncontrolled or severe
cardiovascular disease, including recent myocardial infarction, congestive heart failure,
angina, life threatening arrhythmia, or hypertension Pulmonary: DLCO and spirometry at
least 50% of predicted Other: Not HIV positive Not HBsAG positive Not pregnant Must have
functioning central venous catheter No active infection No uncontrolled diabetes mellitus
No other prior malignancy except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the
patient is currently in complete remission, or any other cancer from which the patient has
been disease free for at least 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior hematopoietic progenitor cell support
Chemotherapy: No prior dose intensive therapy Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified