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A Randomised Comparative Trial of Highly Intensive Chemotherapy With Stem Cell Support vs. Relatively Intensive Chemotherapy (CMF 8 Cycles) in Breast Cancer Patients Node Positive Surgery, Having Received Primary Medical Therapy With an Anthracycline Regimen (NCT00003680)

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 high-dose chemotherapy plus peripheral stem cell transplantation is more effective than standard chemotherapy for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of standard chemotherapy with that of high-dose chemotherapy plus peripheral stem cell transplantation in treating women who have advanced breast cancer or inflammatory breast cancer.
  • Drug: CMF regimen
    • Drug: cyclophosphamide
      • Drug: fluorouracil
        • Drug: methotrexate
          • Drug: tamoxifen citrate
            • Drug: thiotepa
              • Procedure: peripheral blood stem cell transplantation
                • Radiation: radiation therapy
                  Ages eligible for Study
                  18 Years to 60 Years
                  Genders eligible for Study
                  Female
                  Accepts Healthy Volunteers
                  No
                  OBJECTIVES: I. Compare the overall survival in locally advanced, inflammatory, or operable large primary breast cancer (greater than 3 cm) patients with positive axillary lymph nodes at surgery following primary chemotherapy, receiving either conventional chemotherapy or high dose chemotherapy as adjuvant therapy. II. Compare the relapse-free survival and quality of life in these patients receiving this therapy.

                  OUTLINE: This is a randomized, multicenter, open label study. Patients are stratified by study center and number of positive axillary lymph nodes at surgery. Patients are randomized to receive conventional or high dose adjuvant chemotherapy. Arm I: Patients receive conventional chemotherapy consisting of cyclophosphamide, methotrexate, and fluorouracil IV administered once every 3 weeks for 8 courses. Arm II: Patients receive high dose chemotherapy. Cyclophosphamide IV is administered on day 1. Patients undergo peripheral blood progenitor cell (PBPC) collection, then receive cyclophosphamide and thiotepa IV for 4 days, 13-28 days after PBPC collection. Peripheral blood progenitor cells are then reinfused. Patients undergo radiotherapy during or after chemotherapy and receive oral tamoxifen for 5 years, beginning at the same time as radiotherapy. Estrogen receptor negative patients may receive tamoxifen at the discretion of the treating physician. Quality of life is assessed before chemotherapy, then at 6, 12, and 24 months. Patients are followed at 12, 18, and 24 months, then annually for 5 years or until death.

                  PROJECTED ACCRUAL: This study will accrue approximately 300 patients.

                  1 locations

                  United Kingdom (1)
                  • C.R.C. Beatson Laboratories
                    Not specified
                    Glasgow, Scotland, United Kingdom, G61 1BD
                  Status:
                  unknown
                  Type:
                  Interventional
                  Phase:
                  Start:
                  31 October, 1998
                  Updated:
                  04 November, 2013
                  Participants:
                  300
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