Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

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.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
      peripheral stem cell transplantation in treating women who have metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Assess the toxicity and response rates to induction therapy with docetaxel and
      doxorubicin in women with chemotherapy naive metastatic breast cancer. II. Assess the
      toxicity and response rates to sequential high dose chemotherapy following induction
      chemotherapy in women with metastatic breast cancer. III. Determine the hematopoietic
      recovery rate following CD34+ selected peripheral blood stem cell support in this patient
      population. IV. Assess the toxicity of noncytotoxic maintenance therapy following high dose
      chemotherapy in this patient population.

      OUTLINE: This is a multicenter study. Patients with no prior chemotherapy for metastatic
      disease receive induction chemotherapy consisting of doxorubicin IV immediately followed by
      docetaxel IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) subcutaneously (SQ)
      beginning on day 2 and continuing until day 11-15. Induction therapy repeats every 3 weeks
      for 4 courses. Within 4 weeks of the last course of induction chemotherapy, patients receive
      mobilization chemotherapy consisting of cyclophosphamide IV for 2 days, and etoposide IV and
      cisplatin IV for 3 days. At 24 hours following completion of chemotherapy, patients receive
      G-CSF SQ twice daily until the target number of peripheral blood stem cells (PBSC) are
      reached. Within 5 weeks following completion of mobilization chemotherapy, patients receive
      cyclophosphamide IV, thiotepa IV, and carboplatin IV continuously on days -7 through -4.
      Patients receive CD34+ selected PBSC on day 0 followed 4 hours later by G-CSF SQ daily and
      continuing until blood counts recover. Within 30 days of blood count recovery or immediately
      following completion of post transplantation radiotherapy, patients receive maintenance
      therapy consisting of oral anastrozole daily until disease progression. Patients with bone
      involvement also receive pamidronate IV over 2 hours monthly for 1 year. Patients are
      followed monthly for 6 months, every 3 months for 1 year, every 4-6 months for 5 years, and
      then annually thereafter.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 12 months.
    

Intervention name(s): filgrastim; anastrozole; carboplatin; cisplatin; cyclophosphamide; docetaxel; doxorubicin hydrochloride; etoposide; pamidronate disodium; thiotepa; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Pamidronate; Cyclophosphamide; Thiotepa; Carboplatin; Docetaxel; Doxorubicin; Liposomal doxorubicin; Etoposide; Anastrozole
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer