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Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer Clinical research trials and Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer. Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer  Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Triptorelin Compared With Either Exemestane or Tamoxifen 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 cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the uptake of estrogen. It is not yet known whether triptorelin is more effective when combined with exemestane or tamoxifen in treating hormone-responsive breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of combining triptorelin with either exemestane or tamoxifen in treating premenopausal women who have hormone-responsive breast cancer.
Details: OBJECTIVES: - Compare the disease-free and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen. - Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens. - Compare the sites of first treatment failure in patients treated with these regimens. - Compare the incidence of second (non-breast) malignancies in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, concurrent adjuvant 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 2 treatment arms. - Arm I: Patients receive triptorelin intramuscularly on day 1 every 28 days. Patients in the adjuvant chemotherapy stratum receive chemotherapy concurrently with triptorelin for at least 2 months (if anthracycline is included) or at least 4 months (if no anthracycline is included). Beginning after the completion of chemotherapy or at least 6 weeks after the initiation of triptorelin, patients receive oral tamoxifen daily. - Arm II: Patients receive triptorelin as in arm I. Beginning after the completion of adjuvant chemotherapy or at least 6 weeks after the initiation of triptorelin, patients also receive oral exemestane 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, every 6 months for 2 years, and annually for 3 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 1,845 patients will be accrued for this study within 4.5 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 negative for invasive disease and ductal carcinoma in situ) with planned radiotherapy - Tumor confined to the breast and axillary nodes - Tumor detected in internal mammary chain nodes by sentinel node procedure and is not enlarged is allowed - 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 after prior surgery 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 - No prior neoadjuvant or adjuvant chemotherapy Endocrine therapy - No prior tamoxifen, other selective estrogen-receptor modulators (SERMs) (e.g., raloxifene), or hormone replacement therapy for more than 1 year before breast cancer diagnosis - No prior neoadjuvant or adjuvant endocrine therapy since diagnosis of 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 concurrent SERMs (e.g., raloxifene) Radiotherapy - See Disease Characteristics - No prior ovarian radiotherapy Surgery - See Disease Characteristics - No prior bilateral oophorectomy 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 agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraWalley, Study Chair, Tom Baker Cancer Center - Calgary
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Barbara Walley 403-670-1013
Ospedale Beata Vergine *Recruiting*
Mendrisio, , CH-6850
Switzerland
Recruiting Olivia Pagani 41-91-811-3467
Additional Information:
Study ID Numbers: CDR0000316458; NABCI-IBCSG-25-02,BIG-3-02,IBCSG-25-02
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066703
Other Stage 3a Breast Cancer Studies:
1. Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
2. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
3. Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
4. MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
5. Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
Related Studies:
Other stage 3A breast cancer Clinical Trials
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Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
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