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A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy Clinical research trials and A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy. A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy clinical trial. Subjects frequently get the best healthcare possible for their A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy  A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy
A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy
For Condition: Breast Cancer
Status: Suspended
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: This clinical trial will assess whether BMS-275291 can be administered safely in combination with standard adjuvant therapy for early breast cancer and whether plasma concentrations at trough exceed a target minimum.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. Histologically confirmed pathologic stage 1c-IIIA adenocarcinoma of the breast which has been completely resected. 2. Systemic therapy is planned according to one of the following three regimens: - Tamoxifen (20mg) given orally once per day - Adriamycin (60 mg/m2 IV on Day 1) plus cyclophosphamide (600mg/m2 IV on Day 1), repeated every 21 days for four courses (to begin within 8 weeks after definitive surgery) - Adriamycin (60mg/m2 IV on Day 1) plus cyclophosphamide (600mg/m2 IV on Day 1), repeated every 21 days for four courses, followed by Taxol (175mg/m2 IV on Day 85) repeated every 21 days for four courses (to begin within 8 weeks after definitive surgery). 3. ECOG performance status 0 or 1. 4. Adequate organ function as evidenced by: - ANC > 1500/mm3 - Platelets > 100,000/mm3 - Serum Creatine < 1.5 ULN - Total bilirubin < 1.5 x ULN - AST < 2 x ULN 5. Patients to receive adriamycin must have LVEF > 50% or acceptable function per the institutional practice as assessed by MUGA. 6. Signed informed consent. 7. Women age =/> 18 years 8. Patients must have recovered from reversible adverse events of prior surgery and any radiation therapy. 9. Women of childbearing potential must have a serum or urine pregnancy test within 72 hours prior to the start of study medication. Exclusion Criteria: 1. Patients in whom breast cancer is present at the margin or surgical resection are not eligible in this study. Patients suspicious for residual disease following resection are not eligible. 2. Prior chemotherapy or immunotherapy for breast cancer. 3. Documented metastatic breast cancer. 4. Other malignancy (except carcinoma in situ of the cervix or surgically treated non-melanoma skin cancer) within 5 years of study entry. 5. Pregnant or breastfeeding females. 6. Women of child bearing potential not employing adequate contraception. 7. History of autoimmune diseases such as systemic lupus, rheumatoid arthritis, scleroderma. 8. Any serious underlying medical conditions which would impair the ability ot the patient to receive the planned treatment or which may interfere with the completion of this trial. 9. Planned chemotherapy, hormonal therapy or biological therapy other than those described above. Patients should not be enrolled in any other clinical trials. Use of other investigational agents is not permitted. 10. Any condition that does not permit compliance with the protocol.
Total Enrollment:
Location and Contact Information:
Local Institution
Vancouver, Washington,
United States
Local Institution
Indianapolis, Indiana,
United States
Local Institution
Portland, Oregon,
United States
Local Institution
Cincinnati, Ohio,
United States
Local Institution
Burlington, Vermont,
United States
Local Institution
Green Bay, Wisconsin,
United States
Local Institution
Chicago, Illinois,
United States
Local Institution
Baltimore, Maryland,
United States
Local Institution
Bronx, New York,
United States
Additional Information:
Study ID Numbers: CA161-006;
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036621
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4. Vinorelbine and XR9576 to Treat Cancer
5. LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer
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A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy
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