Breast Cancer Clinical Trial
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.
PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
Full Description
OBJECTIVES:
Compare the disease-free survival, breast cancer-free interval, distant recurrence-free interval 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.
OUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.
Eligibility 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 NOTE: *If all other margins are clear a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed
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 negative or microscopically positive axillary sentinel nodes are eligible
Positive sentinel nodes must have either axillary dissection or radiation of axillary 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)
Bilateral synchronous invasive breast cancer allowed if disease meets all other eligibility criteria
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
If > 1 breast tumor, each tumor must be hormone receptor positive
PATIENT CHARACTERISTICS:
Age
Premenopausal
Sex
Female
Menopausal status
Premenopausal
Estradiol in the premenopausal range after prior surgery OR meets the following criteria:
Menstruating regularly for the past 6 months
Has not used any form of hormonal treatment (including hormonal contraception) within the past 6 months
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 other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of the following:
Stage I papillary thyroid cancer
Stage IA carcinoma of the cervix
Stage IA or B endometrioid endometrial cancer
Borderline or stage I ovarian cancer
No psychiatric, addictive, or other disorder that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
Prior or concurrent neoadjuvant or adjuvant trastuzumab allowed
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 oral or other hormonal contraceptives (i.e., implants or depot injections)
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
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There are 214 Locations for this study
Burbank California, 91505, United States
La Jolla California, 92093, United States
Mission Hills California, 91346, United States
Palm Springs California, 92262, United States
Roseville California, 95661, United States
Sacramento California, 95816, United States
Sacramento California, 95819, United States
San Francisco California, 94115, United States
Whittier California, 90602, United States
Aurora Colorado, 80045, United States
Edwards Colorado, 81632, United States
Fort Collins Colorado, 80524, United States
Fort Collins Colorado, 80528, United States
Farmington Connecticut, 06360, United States
Washington District of Columbia, 20016, United States
Washington District of Columbia, 20307, United States
Jacksonville Florida, 32224, United States
Gainesville Georgia, 30501, United States
Boise Idaho, 83712, United States
Coeur d'Alene Idaho, 83814, United States
Chicago Illinois, 60631, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Evanston Illinois, 60201, United States
Urbana Illinois, 61801, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46515, United States
Fort Wayne Indiana, 46845, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Mishawaka Indiana, 46545, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
Sioux City Iowa, 51101, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Newton Kansas, 67114, United States
Overland Park Kansas, 66209, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Shawnee Mission Kansas, 66204, United States
Topeka Kansas, 66606, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21202, United States
Bethesda Maryland, 20814, United States
Frederick Maryland, 21701, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Concord Massachusetts, 01742, United States
Gloucester Massachusetts, 01930, United States
Lowell Massachusetts, 01854, United States
Peabody Massachusetts, 01960, United States
Midland Michigan, 48670, United States
Royal Oak Michigan, 48073, United States
Saint Joseph Michigan, 49085, United States
Saint Joseph Michigan, 49085, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Kansas City Missouri, 64108, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64114, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64131, United States
Kansas City Missouri, 64132, United States
Saint Joseph Missouri, 64506, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Grand Island Nebraska, 68803, United States
Omaha Nebraska, 68198, United States
Marlton New Jersey, 08053, United States
Vineland New Jersey, 08360, United States
Voorhees New Jersey, 08043, United States
Bronx New York, 10466, United States
Buffalo New York, 14263, United States
New York New York, 10016, United States
Asheboro North Carolina, 27203, United States
Asheville North Carolina, 28801, United States
Asheville North Carolina, 28816, United States
Greensboro North Carolina, 27403, United States
Hendersonville North Carolina, 28791, United States
Kinston North Carolina, 28501, United States
Reidsville North Carolina, 27320, United States
Canton Ohio, 44710, United States
Cleveland Ohio, 44109, United States
Danville Pennsylvania, 17822, United States
Hazleton Pennsylvania, 18201, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Greenville South Carolina, 29615, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Chattanooga Tennessee, 37403, United States
Jackson Tennessee, 38301, United States
Laredo Texas, 78041, United States
Berlin Vermont, 05602, United States
Burlington Vermont, 05401, United States
Tacoma Washington, 98431, United States
Morgantown West Virginia, 26506, United States
Antigo Wisconsin, 54409, United States
Burlington Wisconsin, 53105, United States
Franklin Wisconsin, 53132, United States
Glendale Wisconsin, 53212, United States
Kenosha Wisconsin, 53143, United States
Mequon Wisconsin, 53092, United States
Mequon Wisconsin, 53097, United States
Mequon Wisconsin, 53211, United States
Milwaukee Wisconsin, 53215, United States
Racine Wisconsin, 53406, United States
Waukesha Wisconsin, 53188, United States
Wausau Wisconsin, 54401, United States
Wauwatosa Wisconsin, 53226, United States
Campbelltown New South Wales, 2560, Australia
Coffs Harbour New South Wales, 2450, Australia
Lismore New South Wales, 2480, Australia
Liverpool New South Wales, 2170, Australia
Tamworth New South Wales, 2340, Australia
Taree New South Wales, 2430, Australia
Tweed Heads New South Wales, 2485, Australia
Waratah New South Wales, 2298, Australia
Brisbane Queensland, 4029, Australia
Bedford Park South Australia, 5042, Australia
Hobart Tasmania, 7000, Australia
Launceston Tasmania, 7250, Australia
Box Hill Victoria, 3128, Australia
East Melbourne Victoria, 3002, Australia
East Melbourne Victoria, 3002, Australia
Fitzroy Victoria, 3065, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3004, Australia
Ringwood East Victoria, 3135, Australia
Perth Western Australia, 6000, Australia
Brussels , 1000, Belgium
Huy , 4500, Belgium
Leuven , B-300, Belgium
Liege , B-400, Belgium
Verviers , B-480, Belgium
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Moncton New Brunswick, E1C 8, Canada
Hamilton Ontario, L8V 5, Canada
Toronto Ontario, M9C 1, Canada
Windsor Ontario, N8W 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Cairo , , Egypt
Cairo , , Egypt
Baden-Baden , 76532, Germany
Deggendorf , 94469, Germany
Erlangen , 91054, Germany
Frankfurt , D-605, Germany
Göttingen , D-370, Germany
Karlsruhe , D-761, Germany
Luebeck , D-235, Germany
Mainz , 55101, Germany
Mannheim , 68167, Germany
Mutlangen , D-735, Germany
Nuremberg , D-904, Germany
Regensburg , 93053, Germany
Rodewisch , 08228, Germany
Rosenheim , 83022, Germany
Tuttlingen , 78532, Germany
Budapest , 1122, Hungary
Mumbai , 40001, India
Aviano , 33081, Italy
Bergamo , 24100, Italy
Bolzano , 39100, Italy
Brescia , 25124, Italy
Carpi , 41012, Italy
Milan , 20141, Italy
Pavia , I-271, Italy
Prato , 59100, Italy
Rimini , 47900, Italy
Rozzano , 20089, Italy
Udine , 33100, Italy
Varese , 21100, Italy
Hamilton , 2020, New Zealand
Lima , 34, Peru
Ljubljana , Sl-10, Slovenia
Johannesburg , 2121, South Africa
Gothenburg , S-413, Sweden
Linkoping , S-581, Sweden
Skovde , 541 8, Sweden
Basel , CH-40, Switzerland
Bellinzona , CH-65, Switzerland
Bern , CH-30, Switzerland
Bern , CH-30, Switzerland
Chur , CH-70, Switzerland
Chur , CH-70, Switzerland
Lausanne , 1011, Switzerland
Locarno , 6600, Switzerland
Lugano , CH-69, Switzerland
Mendrisio , CH-68, Switzerland
St. Gallen , CH-90, Switzerland
Thun , 3600, Switzerland
Zurich , CH-80, Switzerland
Cambridge England, CB2 2, United Kingdom
Peterborough England, PE3 6, United Kingdom
South Shields England, NE34 , United Kingdom
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