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Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer Clinical research trials and Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer. Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer  Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
For Condition: stage 2 breast cancer,stage 3A breast cancer,stage 1 breast cancer
Status: Recruiting
Sponsor(s): International Breast Cancer Study Group , National Cancer Institute (NCI),Breast International Group
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of ovarian suppression plus either tamoxifen or exemestane with that of tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.
Details: OBJECTIVES: - Compare ovarian function suppression (by triptorelin, oophorectomy, or ovarian irradiation) in combination with tamoxifen vs ovarian function suppression in combination with exemestane vs tamoxifen alone in patients with endocrine-responsive breast cancer. - Compare the disease-free and overall survival of patients treated with these regimens. - Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens. - Compare the incidence of second (nonbreast) malignancies in patients treated with these regimens. - Compare the sites of first treatment failure in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior adjuvant/neoadjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more). Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive oral tamoxifen daily. - Patients receive tamoxifen as in arm I and ovarian function suppression by 1 of the following treatments: - Triptorelin intramuscularly once every 28 days - Surgical oophorectomy - Ovarian irradiation once daily for 4 or 5 days - Arm III: Patients receive oral exemestane daily and ovarian function suppression as in arm II. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 3,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Completely resected disease - No clinically detectable residual loco-regional axillary disease - Prior surgery for primary breast cancer of 1 of the following types: - Total mastectomy with or without adjuvant radiotherapy - Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins clear of invasive disease and ductal carcinoma in situ) with radiotherapy - No more than 12 weeks since prior surgery if no adjuvant chemotherapy - No more than 6 months since prior adjuvant chemotherapy - Tumor confined to the breast and axillary nodes - Tumor detected in internal mammary chain nodes that are not enlarged is allowed - Prior neoadjuvant therapy allowed provided disease was operable prior to neoadjuvant therapy - Axillary lymph node dissection or a negative axillary sentinel node biopsy required - Patients with microscopically positive axillary sentinel nodes are eligible if they are randomized in a clinical study evaluating those lymph nodes - No distant metastases - No locally advanced inoperable breast cancer, including any of the following: - Inflammatory breast cancer - Supraclavicular node involvement - Enlarged internal mammary nodes (unless pathologically negative) - No bilateral invasive breast cancer - No prior ipsilateral or contralateral invasive breast cancer - Hormone receptor status: - Estrogen and/or progesterone receptor positive - At least 10% of the tumor cells positive by immunohistochemistry PATIENT CHARACTERISTICS: Age - Premenopausal Sex - Female Menopausal status - Premenopausal - Estradiol in the premenopausal range - Temporary chemotherapy-induced amenorrhea allowed provided premenopausal status is regained within 6 months of the final dose of chemotherapy Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - No systemic hepatic disease that would preclude prolonged follow-up Renal - No systemic renal disease that would preclude prolonged follow-up Cardiovascular - No systemic cardiovascular disease that would preclude prolonged follow-up - No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is medically suitable Pulmonary - No systemic pulmonary disease that would preclude prolonged follow-up Other - Not pregnant or nursing - Fertile patients must use effective nonhormonal contraception - No history of noncompliance to medical regimens - No other nonmalignant systemic disease that would preclude prolonged follow-up - No prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or bladder, or contralateral or ipsilateral carcinoma in situ of the breast - No psychiatric, addictive, or other disorder that would preclude ability to provide informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - More than 1 year since prior selective estrogen-receptor modulators (SERMs) before the breast cancer diagnosis - More than 1 year since prior hormone replacement therapy before the breast cancer diagnosis - No prior endocrine therapy, including adjuvant or neoadjuvant therapy, for more than 6 months after breast cancer diagnosis - No prior gonadotropin-releasing hormone analogues for breast cancer - No concurrent oral or transdermal hormonal therapy - No other concurrent estrogen, progesterone, or androgens - No other concurrent aromatase inhibitors - No concurrent hormone replacement therapy - No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections) - No other concurrent SERMs (e.g., raloxifene) Radiotherapy - See Disease Characteristics - No prior ovarian radiotherapy Surgery - See Disease Characteristics - No prior oophorectomy - No concurrent oophorectomy unless performed as part of this study Other - No concurrent bisphosphonates, except in the following cases: - Bone density is at least 1.5 standard deviations below the young adult normal mean - Participation in a randomized clinical study testing bisphosphonates in the adjuvant breast cancer setting - No other concurrent investigational agent
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PrudenceFrancis, Study Chair, Peter MacCallum Cancer Centre
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Karen Wendling 773-834-7424
Peter MacCallum Cancer Centre *Recruiting*
Melbourne, Victoria, 8006
Australia
Recruiting Prudence Francis 61-39-656-1701
Additional Information:
Study ID Numbers: CDR0000316456; IBCSG-24-02,NABCI-IBCSG-24-02,BIG-2-02
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066690
Other Stage 2 Breast Cancer Studies:
1. Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
2. Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
3. Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
4. MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
5. Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
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Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
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