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High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer Clinical research trials and High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer. High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer  High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer
High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/60 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelCrump, Study Chair, National Cancer Institute of Canada
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Quebec City, Quebec, G1R 2J6
Canada
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 1C4
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8
Canada
Hotel Dieu Hospital - St. Catharines
St. Catharines, Ontario, L2R 5K3
Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
L'Hotel Dieu de Levis
Levis, Quebec, G6V 3Z1
Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Additional Information:
Study ID Numbers: CDR0000065634; CAN-NCIC-MA16
Study Start Date: April 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003032
Other Stage 4 Breast Cancer Studies:
1. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
2. Tipifarnib and Fulvestrant as Second-Line Therapy in Treating Postmenopausal Women With Hormone Receptor-Positive Inoperable Locally Advanced or Metastatic Breast Cancer With Progressive Disease After Previous First-Line Endocrine Therapy
3. BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
4. Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer
5. Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Ontario Clinical Trials
Other Windsor Clinical Trials
High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer
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