Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 65
Updated:3/28/2019
Start Date:August 2003
End Date:June 2020

Use our guide to learn which trials are right for you!

A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer

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.

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.

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
We found this trial at
140
sites
?
mi
from
Burlington, VT
Click here to add this to my saved trials
8600 Old Georgetown Road
Bethesda, Maryland 20814
301-896-3100
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
2600 6th Street Southwest
Canton, Ohio 44710
330-452-9911
Aultman Cancer Center at Aultman Hospital Serving Stark and surrounding counties since 1892, Aultman Hospital...
?
mi
from
Canton, OH
Click here to add this to my saved trials
2500 Metrohealth Dr # C2100
Cleveland, Ohio 44109
(216) 778-5802
MetroHealth Cancer Care Center at MetroHealth Medical Center At the MetroHealth Cancer Care Center, we...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
?
mi
from
Danville, PA
Click here to add this to my saved trials
11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
?
mi
from
Greenville, SC
Click here to add this to my saved trials
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
985950 Nebraska Medical Center
Omaha, Nebraska 68198
402-559-4090
UNMC Eppley Cancer Center at the University of Nebraska Medical Center The Fred & Pamela...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Antigo, Wisconsin 54409
?
mi
from
Antigo, WI
Click here to add this to my saved trials
364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
?
mi
from
Asheboro, NC
Click here to add this to my saved trials
Asheville, North Carolina 28816
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
130 Fisher Road
Berlin, Vermont 05602
(802) 225-5400
Mountainview Medical Our medical oncologists, hematologist, and oncology advanced practice nurse, along with other dedicated...
?
mi
from
Berlin, VT
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Burbank, CA
Click here to add this to my saved trials
Burlington, Wisconsin 53105
?
mi
from
Burlington, WI
Click here to add this to my saved trials
201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
?
mi
from
Burnsville, MN
Click here to add this to my saved trials
Campbelltown, New South Wales 2560
?
mi
from
Campbelltown,
Click here to add this to my saved trials
505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Chanute, KS
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60631
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Coeur d'Alene, Idaho 83814
?
mi
from
Coeur d'Alene, ID
Click here to add this to my saved trials
Concord, Massachusetts 01742
?
mi
from
Concord, MA
Click here to add this to my saved trials
11850 Blackfoot St. NW Suite 130
Coon Rapids, Minnesota 55433
763-236-0808
Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
?
mi
from
Coon Rapids, MN
Click here to add this to my saved trials
2300 N. Edward Street
Decatur, Illinois 62526
217-876-8121
Decatur Memorial Hospital Cancer Care Institute An American flag bearing only 48 stars waved above...
?
mi
from
Decatur, IL
Click here to add this to my saved trials
2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
?
mi
from
Dodge City, KS
Click here to add this to my saved trials
6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
?
mi
from
Edina, MN
Click here to add this to my saved trials
Edwards, Colorado 81632
?
mi
from
Edwards, CO
Click here to add this to my saved trials
700 West Central
El Dorado, Kansas 67042
(316) 889-0099
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
?
mi
from
El Dorado, KS
Click here to add this to my saved trials
600 East Blvd
Elkhart, Indiana 46515
(574) 294-2621
Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
?
mi
from
Elkhart, IN
Click here to add this to my saved trials
303 S Nappanee St
Elkhart, Indiana 46514
(574) 296-3200
Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
?
mi
from
Elkhart, IN
Click here to add this to my saved trials
2650 Ridge Ave.
Evanston, Illinois 60201
847.570.2000
Evanston Hospital Evanston Hospital, opened in 1891, is the nucleus of the NorthShore University HealthSystem....
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Farmington, CT
Click here to add this to my saved trials
2315 E Harmony Rd #110
Fort Collins, Colorado 80528
(970) 212-7600
Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
Franklin, Wisconsin 53132
?
mi
from
Franklin, WI
Click here to add this to my saved trials
?
mi
from
Frederick, MD
Click here to add this to my saved trials
550 Osborne Road
Fridley, Minnesota 55432
763-236-5000
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
?
mi
from
Fridley, MN
Click here to add this to my saved trials
743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
Glendale, Wisconsin 53212
?
mi
from
Glendale, WI
Click here to add this to my saved trials
298 Washington St
Gloucester, Massachusetts 01930
(978) 283-4000
Addison Gilbert Hospital Addison Gilbert Hospital is a full service, 58-bed medical/surgical acute care facility....
?
mi
from
Gloucester, MA
Click here to add this to my saved trials
?
mi
from
Grand Island, NE
Click here to add this to my saved trials
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
1740 E Broad St
Hazleton, Pennsylvania 18201
(570) 459-2901
Geisinger Hazleton Cancer Center At the Geisinger Cancer Institute, we strive to better understand cancer...
?
mi
from
Hazleton, PA
Click here to add this to my saved trials
800 N Justice St
Hendersonville, North Carolina 28791
(828) 696-1000
Pardee Memorial Hospital Pardee Hospital is a not-for-profit community hospital founded in 1953 and is...
?
mi
from
Hendersonville, NC
Click here to add this to my saved trials
800 W. Laurel
Independence, Kansas 67301
620-331-4099
Cancer Center of Kansas-Independence Dr. H.E. Hynes founded Cancer Center of Kansas, P. A. in...
?
mi
from
Independence, KS
Click here to add this to my saved trials
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Missouri 64131
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kansas City, Missouri 64114
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kansas City, Missouri 64108
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
2800 Clay Edwards Dr
Kansas City, Missouri 64116
(816) 691-2000
North Kansas City Hospital Generations of Northlanders have considered North Kansas City Hospital as their...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kenosha, Wisconsin 53143
?
mi
from
Kenosha, WI
Click here to add this to my saved trials
750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Kingman, KS
Click here to add this to my saved trials
Kokomo, Indiana 46904
?
mi
from
Kokomo, IN
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
1007 LINCOLNWAY
La Porte, Indiana 46350
219.326.1234
Center for Cancer Therapy at LaPorte Hospital and Health Services United in our mission, the...
?
mi
from
La Porte, IN
Click here to add this to my saved trials
Laredo, Texas 78041
?
mi
from
Laredo, TX
Click here to add this to my saved trials
325 Maine Street
Lawrence, Kansas 66044
(785) 505-5000
Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
?
mi
from
Lawrence, KS
Click here to add this to my saved trials
295 Varnum Ave
Lowell, Massachusetts 01854
(978) 937-6000
Lowell General Hospital Welcome to Lowell General Hospital! Our goal is to provide you with...
?
mi
from
Lowell, MA
Click here to add this to my saved trials
1575 Beam Avenue
Maplewood, Minnesota 55109
651-232-7970
HealthEast Cancer Care at St. John's Hospital From the moment patients and visitors walk into...
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
90 Brick Rd
Marlton, New Jersey 08053
(856) 355-6000
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Virtua collaborates with Fox...
?
mi
from
Marlton, NJ
Click here to add this to my saved trials
?
mi
from
Mequon, WI
Click here to add this to my saved trials
?
mi
from
Mequon, WI
Click here to add this to my saved trials
?
mi
from
Mequon, WI
Click here to add this to my saved trials
Midland, Michigan 48670
?
mi
from
Midland, MI
Click here to add this to my saved trials
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
701 Park Ave
Minneapolis, Minnesota 55415
(612) 873-3000
Hennepin County Medical Center - Minneapolis Hennepin Healthcare System, Inc. operates Hennepin County Medical Center...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
800 E 28th St
Minneapolis, Minnesota 55407
612-863-4000
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital As the largest hospital in the...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
5215 Holy Cross Parkway
Mishawaka, Indiana 46545
574-335-5000
Saint Joseph Regional Medical Center Saint Joseph Regional Medical Center is a not-for-profit, multi-hospital health...
?
mi
from
Mishawaka, IN
Click here to add this to my saved trials
Mission Hills, California 91346
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
160 E 34th St
New York, New York 10016
(212) 731-5001
NYU Cancer Institute at New York University Medical Center The Perlmutter Cancer Center takes a...
?
mi
from
New York, NY
Click here to add this to my saved trials
720 Medical Center Drive
Newton, Kansas 67114
(316) 282-0888
Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Newton, KS
Click here to add this to my saved trials
5721 W 119th St
Overland Park, Kansas 66209
(913) 498-6000
Menorah Medical Center Menorah Medical Center (MMC), a full-service, acute care hospital located on the...
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Palm Springs, CA
Click here to add this to my saved trials
1902 S. US Hwy 59
Parsons, Kansas 67357
(620) 421-2855
Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Parsons, KS
Click here to add this to my saved trials
Peabody, Massachusetts 01960
?
mi
from
Peabody, MA
Click here to add this to my saved trials
124 Commodore, Ste. A
Pratt, Kansas 67124
(620) 672-2478
Cancer Center of Kansas, PA - Pratt Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Pratt, KS
Click here to add this to my saved trials
Racine, Wisconsin 53406
?
mi
from
Racine, WI
Click here to add this to my saved trials
Reidsville, North Carolina 27320
?
mi
from
Reidsville, NC
Click here to add this to my saved trials
?
mi
from
Robbinsdale, MN
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Roseville, CA
Click here to add this to my saved trials
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Sacramento, California 95819
?
mi
from
Sacramento, CA
Click here to add this to my saved trials