High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00003032
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 224
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
🇨🇦Quebec City, Quebec, Canada
William Osler Health Centre
🇨🇦Brampton, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Queen Elizabeth Hospital, PEI
🇨🇦Charlottetown, Prince Edward Island, Canada
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
L'Hotel Dieu de Levis
🇨🇦Levis, Quebec, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
McGill University Department of Oncology
🇨🇦Montreal, Quebec, Canada
Hotel Dieu Hospital - St. Catharines
🇨🇦St. Catharines, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Hotel Dieu de Montreal
🇨🇦Montreal, Quebec, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Ottawa Regional Cancer Centre - General Campus
🇨🇦Ottawa, Ontario, Canada