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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 Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. 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 site dedicated 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 localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties 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 volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes 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. Human subjects often get the best healthcare available 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. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous 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
Other Breast Cancer Studies:
1. Phase I Study of SU006668 in Patients With Advanced Solid Tumors
2. Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
3. Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
4. Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
5. Decitabine in Treating Patients With Advanced Solid Tumors
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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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