Trial Information

A Randomized Trial of High-Dose Chemotherapy and Autologous Stem Cell Therapy Versus Standard Therapy in Women With Metastatic Breast Cancer Who Have Responded to Anthracycline or Taxane-Based Induction Chemotherapy

OBJECTIVES: I. Compare the overall survival of women with metastatic breast cancer receiving
either high dose chemotherapy and autologous peripheral blood stem cell therapy or standard
therapy following response to anthracycline or taxane based chemotherapy. II. Evaluate the
final response rates between the two treatment arms. III. Compare the two treatment arms
with respect to toxic effects. IV. Assess health related quality of life in both groups of
patients.

OUTLINE: This is a multicenter, nonblinded, randomized study. Patients are stratified by
type of induction chemotherapy, response status, presence of visceral disease, receptor
status and tamoxifen therapy (ER negative; ER positive, no prior tamoxifen; ER positive,
failed tamoxifen; receptor status unknown). A quality of life questionnaire is given to each
patient before and during treatment, then every 3 months thereafter. Patients are assessed
following 4 courses of induction chemotherapy. Those achieving complete remission, partial
remission, or who have no evaluable disease are randomized to either treatment arm I or arm
II. For treatment arm I, stem cells are mobilized by chemotherapy (courses 5 and 6) plus
filgrastim (G-CSF) or with G-CSF alone. Following course 6, patients receive daily doses of
IV cyclophosphamide, mitoxantrone, and carboplatin on days -6 to -3, followed by stem cell
infusion on day 0 and G-CSF from day 5. In arm II, patients receive two further courses of
standard induction chemotherapy, followed by maintenance chemotherapy at the discretion of
the treating physician. All patients with positive receptor status or unknown receptor
status who have not previously failed tamoxifen therapy, receive tamoxifen at the completion
of post peripheral stem cell transplant (arm I) or induction chemotherapy (arm II).
Following hematologic recovery from high dose chemotherapy patients in arm I with limited
disease receive consolidated radiation and may also receive surgical treatment for limited
disease. In arm II, patients who completed courses 5 and 6 of induction chemotherapy receive
involved field radiation at the physician's discretion. Patients from arm II may also
receive surgical treatment following protocol therapy at the physician's discretion.
Patients are followed every 3 months until death.

PROJECTED ACCRUAL: This study will accrue approximately 50 patients per year for a total of
192 patients in 3.8 years.