DRUG
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Status
Completed
Phase
Phase 3
Enrollment
2,672
Locations
228
Results
Posted
Publications
12
Study summary
What the protocol is testing.
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 detailed 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.
Interventions
Treatment arms and agents.
DRUG
tamoxifen
DRUG
triptorelin
Timeline
From registration to results.
First posted
Aug 7, 2003
Study start
Nov 3, 2003
Primary completion
Mar 11, 2011
Study completion
Oct 23, 2024
Results posted
Apr 5, 2016
Registry updated
Feb 6, 2026
Outcomes
What the study measures.
Primary outcomes
Disease-free Survival
Time frame · 5-year estimate reported at a median follow-up of 72 months
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.
Secondary outcomes
Breast Cancer-free Interval
Time frame · 5-year estimate reported at a median follow-up of 72 months
Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Distant Recurrence-free Interval
Time frame · 5-year estimates reported at a median follow-up of 72 months
Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up
Overall Survival
Time frame · 8-year estimates, reported at a median follow-up of 9 years
Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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
Study locations
228 registered sites.
Australia · Belgium · Brazil · Canada · Egypt · Germany · Hungary · India · Italy · New Zealand · Peru · Slovenia · South Africa · Sweden · Switzerland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Providence Holy Cross Cancer Center
Mission Hills, California, United States
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States
Sutter Cancer Center at Roseville Medical Center
Roseville, California, United States
Sutter Cancer Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
Whittier, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Shaw Regional Cancer Center
Edwards, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
Kootenai Cancer Center - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Resurrection Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Publications
Results and literature.
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