High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00003032
First received: November 1, 1999
Last updated: November 7, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: filgrastim
Drug: cisplatin
Drug: cyclophosphamide
Drug: mitoxantrone hydrochloride
Drug: tamoxifen citrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Trial of High-Dose Chemotherapy and Autologous Stem Cell Therapy Versus Standard Therapy in Women With Metastatic Breast Cancer Who Have Responded to Anthracycline or Taxane-Based Induction Chemotherapy

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Estimated Enrollment: 192
Study Start Date: April 1997
Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Metastatic disease and/or axillary node or chest wall recurrence following mastectomy diagnosed at least 3 months since prior adjuvant chemotherapy Radiologic scans required No inflammatory carcinoma of the breast without metastases (i.e. T4d M0) No previously untreated inflammatory carcinoma of the breast (T4d) No recurrent breast cancer diagnosed less than 3 months since prior adjuvant chemotherapy No history or evidence of CNS (brain or leptomeningeal) metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 16 to 60 Sex: Female Performance status: ECOG 0-2 Menopausal status: Not specified Life expectancy: Not specified Hematopoietic: Hemoglobin at least 100 g/L Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and/or ALT no greater than 3 times upper limit of normal OR AST and/or ALT no greater than 5 times upper limit of normal, if liver metastases Bilirubin no greater than 1.5 times upper limit of normal Renal: Serum creatinine no greater than 2 times upper limit of normal Cardiovascular: No history of congestive heart failure OR At least 1 year since prior myocardial infarction LVEF at least 45% or normal (ECHO or MUGA are acceptable) Other: No prior or concurrent malignancies allowed, except adequately treated squamous or basal cell carcinoma of the skin or in situ carcinoma of the cervix, or cancer treated more than 5 years ago and presumed cured Not HIV positive No clinical evidence of AIDS Not pregnant or nursing Effective contraception required of fertile patients No major medical illness precluding safe administration of planned treatment or required follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifier therapy Chemotherapy: No prior chemotherapy for metastatic or recurrent breast cancer Induction chemotherapy required Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: Concurrent radiotherapy allowed for pain control or to solitary bone or soft tissue sites Surgery: Prior oophorectomy allowed See Disease Characteristics

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003032

Locations
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6ZB
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
William Osler Health Centre
Brampton, Ontario, Canada, L6W 2Z8
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Hotel Dieu Hospital - St. Catharines
St. Catharines, Ontario, Canada, L2R 5K3
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Humber River Regional Hospital
Weston, Ontario, Canada, M9N 1N8
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Prince Edward Island
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
L'Hotel Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Hotel Dieu de Montreal
Montreal, Quebec, Canada, H2W 1T8
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Michael R. Crump, MD, FRCPC Princess Margaret Hospital, Canada
  More Information

Additional Information:
Publications:
Dancey J, Crump M, Gluck S, et al.: Quality of life (QOL) analysis of a randomized trial of high-dose chemotherapy (HDCT) with peripheral stem cell transplant (PSCT) versus standard chemotherapy (SCT) in women with metastatic breast cancer (MBC): National Cancer Institute of Canada Clinical Trials Group study (NCIC CTG) MA-16 . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-3010, 749, 2003.

ClinicalTrials.gov Identifier: NCT00003032     History of Changes
Other Study ID Numbers: MA16, CAN-NCIC-MA16, CDR0000065634
Study First Received: November 1, 1999
Last Updated: November 7, 2010
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Mitoxantrone
Tamoxifen
Alkylating Agents
Analgesics
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Bone Density Conservation Agents
Central Nervous System Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Sensory System Agents

ClinicalTrials.gov processed this record on October 21, 2014