High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It
      is not yet known whether standard therapy is more effective than high dose chemotherapy for
      breast cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy
      plus peripheral stem cell transplantation with that of standard therapy in treating women
      with metastatic or recurrent breast cancer that has responded to previous chemotherapy.
    

Detailed description: 
      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.
    

Intervention name(s): filgrastim; cisplatin; cyclophosphamide; mitoxantrone hydrochloride; tamoxifen citrate
Intervention type(s): Biological; Drug; Drug; Drug; Drug
Intervention MeSH terms: Tamoxifen; Cyclophosphamide; Mitoxantrone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer