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Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected 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 Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer Clinical research trials and Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected 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 Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer. Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected 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 Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected 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 > "S" Clinical Trials Conditions > Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer  Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer
Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer
For Condition: stage 3A breast cancer,stage 2 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. Suppression of ovarian function combined with hormone therapy may fight breast cancer by reducing the production of estrogen. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether suppression of ovarian function and hormone therapy are more effective with or without chemotherapy in treating breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of ovarian-function suppression and hormone therapy with or without chemotherapy in treating premenopausal women who have resected breast cancer.
Details: OBJECTIVES: - Compare ovarian function suppression and tamoxifen or exemestane with vs without adjuvant chemotherapy in premenopausal women with endocrine-responsive resected breast cancer. - Compare the disease-free and overall survival of patients treated with these regimens. - Compare sites of first treatment failure in patients treated with these regimens. - Compare the incidence of second nonbreast malignancies in patients treated with these regimens. - Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more), method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation), chemotherapy if randomized to arm II (not containing vs containing an anthracycline or taxane), and endocrine agent (tamoxifen vs exemestane vs selected by subsequent randomization in the TEXT trial). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive ovarian function suppression comprising triptorelin intramuscularly on day 1 every 28 days for 5 years, oophorectomy, or ovarian irradiation. Beginning when ovarian function has been suppressed, patients also receive oral tamoxifen or exemestane once daily for 5 years in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive ovarian function suppression as in arm I and concurrent chemotherapy for at least 2 months (if an anthracycline is included) or at least 4 months (if no anthracycline is included). Beginning after the completion of chemotherapy or when ovarian function has been suppressed, patients also receive oral tamoxifen or exemestane as in arm I. 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 1,750 patients will be accrued for this study within 7 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer confined to the breast and axillary nodes - No distant metastatic disease - Tumor detected in the internal mammary chain by sentinel node procedure allowed - Must have undergone 1 of the following procedures for primary breast cancer within the past 12 weeks and have no known clinical residual locoregional disease: - Total mastectomy with or without adjuvant radiotherapy - Breast-conserving surgery (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins clear of invasive cancer and ductal carcinoma in situ) followed by radiotherapy - Prior axillary lymph node dissection or negative axillary sentinel node biopsy required - Patients with microscopically positive axillary sentinel nodes allowed provided they were evaluated on a clinical trial evaluating microscopically positive lymph nodes - No locally advanced, inoperable breast cancer, including any of the following characteristics: - 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 receptor and/or progesterone receptor positive - At least 10% of tumor cells positive by immunohistochemistry PATIENT CHARACTERISTICS: Age - Premenopausal Sex - Female Menopausal status - Premenopausal - Estradiol in the premenopausal range after 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 prior deep venous thrombosis and/or embolism unless patient is medically suitable - No systemic cardiovascular disease that would preclude prolonged follow-up Pulmonary - No systemic pulmonary disease that would preclude prolonged follow-up Other - Not pregnant or nursing - Fertile patients must use effective nonhormonal contraception - No other 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 other nonmalignant systemic disease that would preclude prolonged follow-up - No history of noncompliance with medical regimens - No psychiatric, addictive, or other disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior neoadjuvant or adjuvant chemotherapy Endocrine therapy - No prior neoadjuvant or adjuvant endocrine therapy after breast cancer diagnosis - No prior tamoxifen or other selective estrogen-receptor modulator (e.g., raloxifene) within 1 year before the breast cancer diagnosis - No other concurrent oral or transdermal hormonal therapy, including any of the following: - Estrogen - Progesterone - Androgens - Aromatase inhibitors - Hormone replacement therapy - Oral or other hormonal contraceptives, including implant and depot injections - Raloxifene or other selective estrogen-receptor modulators Radiotherapy - See Disease Characteristics - No prior ovarian irradiation Surgery - See Disease Characteristics - No prior bilateral oophorectomy Other - No other prior neoadjuvant therapy - No other concurrent investigational agents - No concurrent bisphosphonates unless bone density has been documented at least 1.5 standard deviations below the young adult normal mean or the patient is participating in a randomized clinical trial setting testing bisphosphonates in the adjuvant breast cancer setting
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdithPerez, Study Chair, Mayo Clinic
Cancer Treatment Center at Pekin Hospital *Recruiting*
Pekin, Illinois, 61554
United States
Recruiting Contact Person 309-347-1151
Graham Hospital Association *Recruiting*
Canton, Illinois, 61520
United States
Recruiting Contact Person 309-647-5240
North Idaho Cancer Center *Recruiting*
Coeur D Alene, Idaho, 83814
United States
Recruiting Contact Person 208-666-3800
Galesburg Cottage Hospital *Recruiting*
Galesburg, Illinois, 61401
United States
Recruiting Contact Person 309-343-8131
Eureka Hospital *Recruiting*
Eureka, Illinois, 61530
United States
Recruiting Contact Person 309-467-2371
Community Hospital of Ottawa *Recruiting*
Ottawa, Illinois, 61350
United States
Recruiting Contact Person 815-433-3100
Oncology/Hematology Associates of Central Illinois, P.C. *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting Contact Person 309-672-5681
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Contact Person 712-252-0088
Proctor Hospital *Recruiting*
Peoria, Illinois, 61614
United States
Recruiting Contact Person 309-691-1000
BroMenn Regional Medical Center *Recruiting*
Normal, Illinois, 61761
United States
Recruiting Contact Person 309-454-1400
Perry Memorial Hospital *Recruiting*
Princeton, Illinois, 61356
United States
Recruiting Contact Person 815-875-2811
OSF St. Francis Medical Center *Recruiting*
Peoria, Illinois, 61637
United States
Recruiting Contact Person 309-655-2000
Stormont-Vail Healthcare *Recruiting*
Topeka, Kansas, 66606
United States
Recruiting Contact Person 913-354-5300
Wayne Memorial Hospital, Inc. *Recruiting*
Goldsboro, North Carolina, 27533
United States
Recruiting Contact Person 919-736-1110
St. Joseph Medical Center *Recruiting*
Bloomington, Illinois, 61701
United States
Recruiting Contact Person 309-662-3311
Montana Cancer Institute - Benefis Healthcare *Recruiting*
Great Falls, Montana, 59405
United States
Recruiting Contact Person 406-455-2056
Methodist Medical Center of Illinois *Recruiting*
Peoria, Illinois, 61636
United States
Recruiting Contact Person 309-672-5522
Valley Cancer Center *Recruiting*
Spring Valley, Illinois, 61362
United States
Recruiting Contact Person 815-664-4141
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center *Recruiting*
La Crosse, Wisconsin, 54601
United States
Recruiting Contact Person 608-782-7300
Sarah D. Culbertson Memorial Hospital *Recruiting*
Rushville, Illinois, 62681
United States
Recruiting Contact Person 217-322-4321
Community Cancer Center *Recruiting*
Normal, Illinois, 61761
United States
Recruiting Contact Person 309-451-2231
McDonough District Hospital *Recruiting*
Macomb, Illinois, 61455
United States
Recruiting Contact Person 309-833-4101
Intercommunity Cancer Center *Recruiting*
Lisle, Illinois, 60532
United States
Recruiting Contact Person 708-505-3192
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting Contact Person 309-636-3605
Galesburg Clinic *Recruiting*
Galesburg, Illinois, 61401
United States
Recruiting Contact Person 309-636-3605
Mason District Hospital *Recruiting*
Havana, Illinois, 62644
United States
Recruiting Contact Person 309-543-4431
Kewanee Hospital *Recruiting*
Kewanee, Illinois, 61443
United States
Recruiting Contact Person 309-853-3361
Memorial Hospital *Recruiting*
Carthage, Illinois, 62321
United States
Recruiting Contact Person 217-357-3131
Hopedale Medical Complex *Recruiting*
Hopedale, Illinois, 61747
United States
Recruiting Contact Person 309-449-3321
St. Margaret's Hospital *Recruiting*
Spring Valley, Illinois, 61362
United States
Recruiting Contact Person 815-664-5311
Illinois Valley Community Hospital *Recruiting*
Peru, Illinois, 61354
United States
Recruiting Contact Person 815-223-3000
Sioux Valley Hospital at University of South Dakota Medical Center *Recruiting*
Sioux Falls, South Dakota, 57117-5039
United States
Recruiting Contact Person 605-333-1000
Additional Information:
Study ID Numbers: CDR0000318832; IBCSG-26-02,BIG-4-02,NABCI-IBCSG-26-02
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066807
Other Stage 1 Breast Cancer Studies:
1. Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
2. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
3. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
4. EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
5. Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
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Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer
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