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


Phase 3
N/A
N/A
Open (Enrolling)
Female
Estrogen Receptor-positive Breast Cancer, Progesterone Receptor-positive Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer

Thank you

Trial Information

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


OBJECTIVES:

I. 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.

II. Compare the quality of life, including late side effects of early menopause, of patients
treated with these regimens.

III. Compare the sites of first treatment failure in patients treated with these regimens.

IV. 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 approximately 6-8 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 approximately 6-8 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.


Inclusion Criteria:



- 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 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

- Female

- 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

- No systemic hepatic disease that would preclude prolonged follow-up

- No systemic renal disease that would preclude prolonged follow-up

- 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

- No systemic pulmonary disease that would preclude prolonged follow-up

- 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, non-breast carcinoma in situ, contralateral or ipsilateral
carcinoma in situ of the breast, or other non recurrent invasive non-breast
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 or concurrent neoadjuvant or adjuvant trastuzumab allowed

- No prior neoadjuvant or adjuvant chemotherapy

- 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)

- 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 prior ovarian radiotherapy

- No other concurrent investigational agents

- No prior bilateral oophorectomy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival (DFS)

Outcome Description:

Using two-sided stratified logrank tests to determine if the treatment groups are different, with an alpha level of 0.05. Kaplan-Meier estimates of the DFS distributions will be calculated for each of the two arms. Cox proportional hazards regression models will be used to investigate whether the treatment comparison is modified by adjustments for various covariates.

Outcome Time Frame:

From randomization to local, regional or distant relapse, contralateral breast cancer, appearance of a second (non-breast) primary tumor, or death from any cause, whichever occurs first, assessed up to 6 years

Safety Issue:

No

Principal Investigator

Barbara Walley

Investigator Role:

Principal Investigator

Investigator Affiliation:

International Breast Cancer Study Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-01087

NCT ID:

NCT00066703

Start Date:

August 2003

Completion Date:

Related Keywords:

  • Estrogen Receptor-positive Breast Cancer
  • Progesterone Receptor-positive Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Breast Neoplasms

Name

Location

Albert Einstein College of Medicine Bronx, New York  10461
Suburban Hospital Bethesda, Maryland  20814
Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Rochester, Minnesota  55905
Washington University School of Medicine Saint Louis, Missouri  63110
University of Washington Medical Center Seattle, Washington  98195-6043
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Fairview Ridges Hospital Burnsville, Minnesota  55337
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Madigan Army Medical Center Tacoma, Washington  98431-5048
William Beaumont Hospital Royal Oak, Michigan  48073
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Via Christi Regional Medical Center Wichita, Kansas  67214
Group Health Cooperative Seattle, Washington  98112
Great Falls Clinic Great Falls, Montana  59405
Trinity Cancer Care Center Minot, North Dakota  58701
Montefiore Medical Center Bronx, New York  10467-2490
Sibley Memorial Hospital Washington, District of Columbia  20016
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Medical X-Ray Center Sioux Falls, South Dakota  57105
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Elkhart General Hospital Elkhart, Indiana  46515
South Bend Clinic South Bend, Indiana  46617
Front Range Cancer Specialists Fort Collins, Colorado  80528
Poudre Valley Hospital Fort Collins, Colorado  80524
Memorial Hospital Carthage, Illinois  62321
Galesburg Cottage Hospital Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Proctor Hospital Peoria, Illinois  61614
Perry Memorial Hospital Princeton, Illinois  61356
Valley Cancer Center Spring Valley, Illinois  61362
Doctor's Hospital of Laredo Laredo, Texas  78041
Mountainview Medical Berlin, Vermont  05602
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Eureka Hospital Eureka, Illinois  61530
Mercy Hospital Coon Rapids, Minnesota  55433
Graham Hospital Association Canton, Illinois  61520
Saint Joseph Medical Center Joliet, Illinois  60435
Pekin Hospital Pekin, Illinois  61554
Faulkner Hospital Jamaica Plain, Massachusetts  02130
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Regions Hospital Saint Paul, Minnesota  55101
Geisinger Medical Group State College, Pennsylvania  16801
Northeast Georgia Medical Center Gainesville, Georgia  30501
Central Maine Medical Center Lewiston, Maine  04240
Randolph Hospital Asheboro, North Carolina  27203
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Menorah Medical Center Overland Park, Kansas  66209
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
North Kansas City Hospital Kansas City, Missouri  64116
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Baptist Hospital Nashville, Tennessee  37236
Lowell General Hospital Lowell, Massachusetts  01854
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Mayo Clinic in Florida Jacksonville, Florida  32224
Sutter Roseville Medical Center Roseville, California  95661
Saint Francis Medical Center Grand Island, Nebraska  68802
Newton-Wellesley Hospital Newton, Massachusetts  02462
Providence Medical Center Kansas City, Kansas  66112
Independence Regional Health Center Independence, Missouri  64050
Mercy General Hospital Sacramento, California  95819
Contra Costa Regional Medical Center Martinez, California  94553-3156
Hennepin County Medical Center Minneapolis, Minnesota  
Saint Louis University Hospital St. Louis, Missouri  63110-0250
University of Connecticut Farmington, Connecticut  06032
University of California at San Diego La Jolla, California  92093
Cancer Center of Kansas - McPherson McPherson, Kansas  67460
Mid Dakota Clinic Bismarck, North Dakota  58501
University Of Vermont Burlington,, Vermont  05403
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
Addison Gilbert Hospital Gloucester, Massachusetts  01930
Columbia Saint Mary's Hospital - Ozaukee Mequon, Wisconsin  53097
Providence Holy Cross Medical Center Mission Hills, California  91345
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Tufts Medical Center Boston, Massachusetts  02111
Decatur Memorial Hospital Decatur, Illinois  62526
Mercy Medical Center Baltimore, Maryland  21202
Frederick Memorial Hospital Frederick, Maryland  21701
Desert Regional Medical Center Palm Springs, California  92262
Boca Raton Comprehensive Cancer Center Boca Raton, Florida  33486
Providence Saint Joseph Medical Center Burbank, California  91505-4866
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
University of Southern California Los Angeles, California  90033
Northern Indiana Cancer Research Consortium South Bend, Indiana  
OSF Saint Francis Medical Center Peoria, Illinois  61637
Sutter General Hospital Sacramento, California  95816
University of California San Francisco Medical Center-Mount Zion San Francisco, California  94115
Saint Anthony Central Hospital Denver, Colorado  80204
Middlesex Hospital Middletown, Connecticut  06457
The Hospital of Central Connecticut New Britain, Connecticut  06050
Saint Luke's Mountain States Tumor Institute Boise, Idaho  83712
John H Stroger Jr Hospital of Cook County Chicago, Illinois  60612-3785
Resurrection Healthcare Chicago, Illinois  60631
Evanston CCOP-NorthShore University HealthSystem Evanston, Illinois  60201
Intercommunity Cancer Center Galesburg, Illinois  61401
Hopedale Medical Complex - Hospital Hopedale, Illinois  61747
Community Cancer Center Foundation Normal, Illinois  61761
Ottawa Regional Hospital and Healthcare Center Ottawa, Illinois  61350
Pekin Cancer Treatment Center Pekin, Illinois  61554
Illinois Oncology Research Association CCOP Peoria, Illinois  61615
Illinois CancerCare-Peoria Peoria, Illinois  61615
Illinois Valley Hospital Peru, Illinois  61354
Sarah Culbertson Memorial Hospital Rushville, Illinois  62681
Edward H Kaplan MD and Associates Skokie, Illinois  60076
Saint Margaret's Hospital Spring Valley, Illinois  61362
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard Fort Wayne, Indiana  46845
Hematology Oncology Associates-Quad Cities Bettendorf, Iowa  52722
Memorial Hospital of Arkansas City Arkansas City, Kansas  67005
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Radiation Oncology Practice Corporation Southwest Overland Park, Kansas  66210
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Stormont-Vail Regional Health Center Topeka, Kansas  66604
Saint Francis Hospital and Medical Center - Topeka Topeka, Kansas  66606
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Beverly Hospital Beverly, Massachusetts  01915
North Shore Medical Center Cancer Center Peabody, Massachusetts  01960
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Mid-Michigan Medical Center - Midland Midland, Michigan  48670
Saint Mary's of Michigan Saginaw, Michigan  48601
Lakeland Hospital St. Joseph, Michigan  49085
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Unity Hospital Fridley, Minnesota  55432
Saint John's Hospital - Healtheast Maplewood, Minnesota  55109
North Memorial Medical Health Center Robbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota  55416
Radiation Oncology Practice Corporation - North Kansas City, Missouri  64154
Saint Luke's Cancer Institute Kansas City, Missouri  64111
Radiation Oncology Practice Corporation South Kansas City, Missouri  64114
Saint Luke's Hospital of Kansas City Kansas City, Missouri  64111
Saint Joseph Health Center Kansas City, Missouri  64114
Liberty Radiation Oncology Clinic Kansas City, Missouri  64116
Truman Medical Center Kansas City, Missouri  64108
Billings Clinic Billings, Montana  59107-7000
Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana  59405
Portsmouth Regional Hospital Portsmouth, New Hampshire  03802
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly, New Jersey  08060
South Jersey Healthcare Vineland, New Jersey  08360
Virtua West Jersey Hospital Voorhees Voorhees, New Jersey  08043
The North Division of Montefiore Medical Center Bronx, New York  10466
New York University Langone Medical Center New York, New York  10016
Mission Hospitals Inc Asheville, North Carolina  28801
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina  28791
Kinston Medical Specialists PA Kinston, North Carolina  28501
The Boardman Cancer Center Boardman, Ohio  44512
Aultman Health Foundation Canton, Ohio  44710
Saint Joseph Cancer Center Warren, Ohio  44484
Saint Elizabeth Hospital Medical Center Youngstown, Ohio  44501
Natalie W Bryant Cancer Center Tulsa, Oklahoma  74136
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Greenville CCOP Greenville, South Carolina  29615
Sanford Cancer Center-Oncology Clinic Sioux Falls, South Dakota  57104
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
West Virginia University Morgantown, West Virginia  26506
Langlade Hospital and Cancer Center Antigo, Wisconsin  54409
Aspirus Regional Cancer Center Wausau, Wisconsin  54401
University of California Medical Center At Irvine-Orange Campus Orange, California  92868
University of Maryland Greenebaum Cancer Center Baltimore, Maryland  21201
Cedar Valley Medical Specialists Waterloo, Iowa  50702
Emerson Hospital Concord, Massachusetts  01742
Elkhart Clinic Elkhart, Indiana  46515
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora, Colorado  80045
The Shaw Regional Cancer Center Edwards, Colorado  81632
Montrose Memorial Hospital Montrose, Colorado  81401
Kootenai Cancer Center Post Falls, Idaho  83854
Michiana Hematology Oncology PC-South Bend South Bend, Indiana  46601
Hackensack University Medical CCOP Hackensack, New Jersey  07601
Moses Cone Health System-Regional Cancer Center Greensboro, North Carolina  27403
Annie Penn Memorial Hospital Reidsville, North Carolina  27320
Erlanger Medical Center Chattanooga, Tennessee  37403
Aurora Advanced Healthcare Inc-Mequon Mequon, Wisconsin  53092
Hope, A Women's Cancer Center Asheville, North Carolina  28816
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida  33136
Saint Luke's South Hospital Overland Park, Kansas  66213
Heartland Hematology and Oncology Associates Incorporated Kansas City, Missouri  64118
Forsyth Memorial Hospital Winston-Salem, North Carolina  27103
Gundersen Lutheran La Crosse, Wisconsin  54601
Columbia Saint Mary's Water Tower Medical Commons Milwaukee, Wisconsin  53211
San Francisco General Hospital San Francisco, California  94110
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Carle Foundation - Carle Cancer Center Urbana, Illinois  61801
Marie Yeager Cancer Center Saint Joseph, Michigan  49085
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota  57117-5134
Sanford Bismarck Medical Center Bismarck, North Dakota  58501
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Veterans Administration-San Diego Medical Center San Diego, California  92161
Presbyterian Intercommunity Hospital Whittier, California  90602
Saint Anthony Hospital North Westminster, Colorado  80030
Illinois CancerCare Galesburg Galesburg, Illinois  61401
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center-Mishawaka Mishawaka, Indiana  46545-1470
Saint Joseph Regional Medical Center - Mishawaka Plymouth, Indiana  46544
Via Christi Hospital-Pittsburg Pittsburg, Kansas  66762
Benefis Healthcare-West Campus Great Falls, Montana  59405
Moorehead Memorial Hospital Eden, North Carolina  27288
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota  58103
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
Group Health Cooperative of Puget Sound Oncology Consortium Seattle, Washington  98109
Aurora Cancer Care-Burlington Burlington, Wisconsin  53105
Aurora Cancer Care-Franklin Franklin, Wisconsin  53132
Aurora Cancer Care-Glendale Glendale, Wisconsin  53212
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin  53142
Aurora Cancer Care-Milwaukee South Milwaukee, Wisconsin  53215
Aurora Cancer Care-Racine Racine, Wisconsin  53406-5661
Aurora Cancer Care-Waukesha Waukesha, Wisconsin  53188
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin  53226