High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Locally Recurrent or Metastatic 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 to kill more tumor cells. It
      is not yet known if high dose chemotherapy plus peripheral stem cell transplantation is more
      effective than standard therapy 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 who
      have locally recurrent or metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the effect on 3-year survival of intensive chemotherapy with
      cyclophosphamide/thiotepa with peripheral blood stem cell rescue in women with locally
      recurrent or metastatic breast cancer who respond to induction therapy with
      epirubicin/fluorouracil/cyclophosphamide. II. Evaluate the effects of this intensive
      treatment on patient quality of life. III. Evaluate tumor response and progression-free
      survival after intensification.

      OUTLINE: This is a randomized study. Patients are stratified by clinical/therapeutic hormone
      sensitivity and participating institution. All patients receive induction therapy with
      epirubicin, fluorouracil, and cyclophosphamide (FEC 100) every 3 weeks for up to 4 courses,
      with response evaluated after at least 2 courses. Patients with a complete response or at
      least a 50% partial response are randomized either to no further therapy or to receive
      intensification chemotherapy. Patients randomized to intensification undergo peripheral blood
      stem cell (PBSC) harvest with G-CSF mobilization after the third or fourth induction course.
      Three to 6 weeks after induction, patients receive intensification chemotherapy with
      cyclophosphamide/thiotepa followed by PBSC. Post-transplant G-CSF is given for hematopoietic
      support. No concurrent hormonal therapy is permitted during induction; local irradiation of
      multifocal tumors is allowed provided response is still evaluable. Local therapy (excision of
      single metastasis, radiotherapy to metastatic site) is permitted after completion of protocol
      therapy. Treatment of relapsed disease is at the discretion of the investigator. Patients are
      followed every 3 months for 3 years or until relapse, then every 6 months.

      PROJECTED ACCRUAL: A total of 180 patients will be accrued over 3 years in this multicenter
      study.
    

Intervention name(s): filgrastim; cyclophosphamide; epirubicin hydrochloride; fluorouracil; thiotepa; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cyclophosphamide; Thiotepa; Fluorouracil; Epirubicin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer