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Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy 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 Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy Clinical research trials and Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy 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 Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy. Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy 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 Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy clinical trial. Test subjects typically receive the most effective healthcare possible for their Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy 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 > "C" Clinical Trials Conditions > Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy  Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy
Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy
For Condition: stage 1 breast cancer,stage 3A breast cancer,stage 2 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada , North Central Cancer Treatment Group,International Breast Cancer Study Group,Eastern Cooperative Oncology Group,Southwest Oncology Group,Cancer and Leukemia Group B,EORTC Breast Cancer Cooperative Group
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. PURPOSE: Randomized phase III trial to compare the effectiveness of letrozole with that of a placebo in treating women who have resected breast cancer after completion of treatment with tamoxifen.
Details: OBJECTIVES: - Compare the disease-free survival and overall survival of postmenopausal women with primary breast cancer who have completed at least five years of adjuvant tamoxifen treated with letrozole or placebo. - Compare the incidence of contralateral breast cancer in patients treated with these regimens. - Evaluate the long term clinical and laboratory safety of letrozole, in terms of lipid profile, cardiovascular morbidity and mortality, incidence of bone fractures, change in bone density, and common toxic effects, in this patient population. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to receptor status (positive vs unknown), lymph node status (negative vs positive vs unknown), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral letrozole once daily. - Arm II: Patients receive oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at 6 months, and then annually for 4.5 years. Patients are followed annually. PROJECTED ACCRUAL: Approximately 4,800 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis - No ductal carcinoma in situ - Axillary lymph node negative, positive, or unknown - No evidence of metastases - No localized or distant breast cancer recurrence - Not registered on protocol NCCTG-89-30-52, any other IBCSG protocol, or protocol SWOG-S9623 - Hormone receptor status: - Estrogen or progesterone receptor positive as defined by tumor receptor content at least 10 fmol/mg protein or receptor positive by ERICA or PgRICA - Unknown status allowed if effort to determine status has been made by immunocytochemistry PATIENT CHARACTERISTICS: Age: - Postmenopausal Sex: - Female Menopausal status: - Postmenopausal defined by one of the following: - Age 50 or over at start of adjuvant tamoxifen - Under age 50 and considered postmenopausal by treating physician at start of adjuvant tamoxifen - Under age 50 at start of adjuvant tamoxifen and had bilateral oophorectomy (surgical or radiation) - Under age 50 and premenopausal at start of adjuvant tamoxifen, but became amenorrheic during tamoxifen and remained amenorrheic for at least 1 year - Considered postmenopausal by physician with LH/FSH levels under the treatment center's postmenopausal limits Performance status: - ECOG 0-2 Life expectancy: - At least 5 years Hematopoietic: - WBC at least 3,000/mm3 OR - Granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - AST and/or ALT less than 2 times upper limit of normal (ULN) (unless imaging examinations have ruled out metastatic disease) - Alkaline phosphatase less than 2 times ULN (unless imaging examinations have ruled out metastatic disease) Renal: - Not specified Other: - No concurrent medical or psychiatric condition that would preclude study - No other prior or concurrent malignancy within the past 5 years except adequately treated superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix - Able to swallow study drug - Adequate oral intake PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Prior adjuvant chemotherapy allowed - No concurrent chemotherapy Endocrine therapy: - Completed at least 4.5 but no more than 6 years of adjuvant tamoxifen after resection - No more than 3 months since prior adjuvant tamoxifen - No concurrent hormone replacement therapy (e.g., megestrol) - No concurrent selective estrogen-receptor modulators (e.g., raloxifene or idoxifene) - Concurrent intermittent vaginal estrogens (e.g., Estring) allowed if other local measures for intractable vaginal atrophy are insufficient - No other concurrent aromatase inhibitors Radiotherapy: - Prior radiotherapy allowed Surgery: - See Disease Characteristics Other: - At least 1 month since prior investigational drugs - Prior treatment on a clinical trial for breast cancer allowed if permission has been obtained from the sponsors of the original study for their patient to participate on MA.17/JMA.17/BIG-97-01 - Concurrent thyroid medication, calcium, vitamin D, and bisphosphonates allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulGoss, Study Chair, Princess Margaret Hospital
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Centre Hospitalier des Valles de l'Outaouais
Gatineau, Quebec, J8P 7H2
Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
L'Hotel Dieu de Levis
Levis, Quebec, G6V 3Z1
Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, B3H 2Y9
Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Canada
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Canada
Algoma District Medical Group
Sault Sainte Marie, Ontario, P6B 1Y5
Canada
Markham Stouffville Hospital
Markham, Ontario, L3P 7T3
Canada
North York General Hospital, Ontario
North York, Ontario, M2K 1E1
Canada
Withington Hospital
Manchester, England, M20 8LR
United Kingdom
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Nanaimo Cancer Clinic
Nanaimo, British Columbia, V9S 2B7
Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2W 1T8
Canada
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, G1S 4L8
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Lethbridge Cancer Clinic
Lethbridge, Alberta, T1J 1W5
Canada
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8
Canada
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2
Canada
Additional Information:
Study ID Numbers: CDR0000065921; CAN-NCIC-MA17,CLB-JMA17,E-JMA17,EORTC-BIG97-01,IBCSG-BIG97-01,NCCTG-JMA.17,SWOG-JMA17,CLB-49805,EORTC-10983,JRF-Vor-Int-10,NCCTG-CAN-MA17,SWOG-CAN-MA17
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003140
Other Stage 1 Breast Cancer Studies:
1. Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
2. Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer
3. Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
4. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
5. Chemotherapy Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other British Columbia Clinical Trials
Other Surrey Clinical Trials
Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy
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