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ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer Clinical research trials and ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer healthcare trials take place in a lot of 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 assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer. ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer  ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer
ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer
For Condition: stage 2 breast cancer,stage 1 breast cancer
Status: Completed
Sponsor(s): EORTC Breast Cancer Cooperative Group , Breast International Group
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases. PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.
Details: OBJECTIVES: - Determine the inhibitory effect of ICI 182780 on the development of metastasis, as measured by disease-free survival and overall survival, in women with operable stage I or II primary breast cancer. - Determine toxicity of this regimen in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and menopausal status (premenopausal vs postmenopausal). Patients are randomized to receive either ICI 182780 IM or placebo IM over 2 minutes on day 1. Patients undergo surgery between days 8 and 29. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 3,656 patients (1,828 per arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage I or II primary operable breast cancer - Surgery planned within next 1-4 weeks - Hormone receptor status: - Estrogen receptor positive or unknown - No known estrogen receptor negative tumor - Unknown progesterone receptor status eligible PATIENT CHARACTERISTICS: Age: - Any age Sex: - Female Menopausal status: - Premenopausal or postmenopausal Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - No bleeding diathesis not compatible with an IM depot injection Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective non-hormonal contraception during and for 2-3 months after study - No other prior or concurrent malignancy except adequately treated basal cell carcinoma of the skin or cancer of the uterine cervix - No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - At least 2 months since prior ICI 182780 Radiotherapy: - No prior radiotherapy to primary tumor Surgery: - See Disease Characteristics Other: - No other concurrent preoperative therapy for breast cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnthonyHowell, Study Chair, Christie Hospital N.H.S. Trust
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Additional Information:
Study ID Numbers: CDR0000068451; EORTC-10963,BIG-EORTC-10963
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010153
Other Stage 1 Breast Cancer Studies:
1. Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer
2. Trastuzumab in Treating Women With Breast Cancer
3. Epirubicin Combined With Docetaxel Before Surgery in Treating Women With Early Breast Cancer
4. Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy
5. Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other England Clinical Trials
Other Manchester Clinical Trials
ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer
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