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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 MedicineBronx, New York  10461
Suburban HospitalBethesda, Maryland  20814
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Washington University School of MedicineSaint Louis, Missouri  63110
University of Washington Medical CenterSeattle, Washington  98195-6043
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Fairview Ridges HospitalBurnsville, Minnesota  55337
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Madigan Army Medical CenterTacoma, Washington  98431-5048
William Beaumont HospitalRoyal Oak, Michigan  48073
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Via Christi Regional Medical CenterWichita, Kansas  67214
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Trinity Cancer Care CenterMinot, North Dakota  58701
Montefiore Medical CenterBronx, New York  10467-2490
Sibley Memorial HospitalWashington, District of Columbia  20016
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Medical X-Ray CenterSioux Falls, South Dakota  57105
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Elkhart General HospitalElkhart, Indiana  46515
South Bend ClinicSouth Bend, Indiana  46617
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Poudre Valley HospitalFort Collins, Colorado  80524
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Valley Cancer CenterSpring Valley, Illinois  61362
Doctor's Hospital of LaredoLaredo, Texas  78041
Mountainview MedicalBerlin, Vermont  05602
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Eureka HospitalEureka, Illinois  61530
Mercy HospitalCoon Rapids, Minnesota  55433
Graham Hospital AssociationCanton, Illinois  61520
Saint Joseph Medical CenterJoliet, Illinois  60435
Pekin HospitalPekin, Illinois  61554
Faulkner HospitalJamaica Plain, Massachusetts  02130
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Geisinger Medical GroupState College, Pennsylvania  16801
Northeast Georgia Medical CenterGainesville, Georgia  30501
Central Maine Medical CenterLewiston, Maine  04240
Randolph HospitalAsheboro, North Carolina  27203
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Baptist HospitalNashville, Tennessee  37236
Lowell General HospitalLowell, Massachusetts  01854
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Mayo Clinic in FloridaJacksonville, Florida  32224
Sutter Roseville Medical CenterRoseville, California  95661
Saint Francis Medical CenterGrand Island, Nebraska  68802
Newton-Wellesley HospitalNewton, Massachusetts  02462
Providence Medical CenterKansas City, Kansas  66112
Independence Regional Health CenterIndependence, Missouri  64050
Mercy General HospitalSacramento, California  95819
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Hennepin County Medical CenterMinneapolis, Minnesota  
Saint Louis University HospitalSt. Louis, Missouri  63110-0250
University of ConnecticutFarmington, Connecticut  06032
University of California at San DiegoLa Jolla, California  92093
Cancer Center of Kansas - McPhersonMcPherson, Kansas  67460
Mid Dakota ClinicBismarck, North Dakota  58501
University Of VermontBurlington,, Vermont  05403
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Addison Gilbert HospitalGloucester, Massachusetts  01930
Columbia Saint Mary's Hospital - OzaukeeMequon, Wisconsin  53097
Providence Holy Cross Medical CenterMission Hills, California  91345
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Tufts Medical CenterBoston, Massachusetts  02111
Decatur Memorial HospitalDecatur, Illinois  62526
Mercy Medical CenterBaltimore, Maryland  21202
Frederick Memorial HospitalFrederick, Maryland  21701
Desert Regional Medical CenterPalm Springs, California  92262
Boca Raton Comprehensive Cancer CenterBoca Raton, Florida  33486
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
University of Southern CaliforniaLos Angeles, California  90033
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Sutter General HospitalSacramento, California  95816
University of California San Francisco Medical Center-Mount ZionSan Francisco, California  94115
Saint Anthony Central HospitalDenver, Colorado  80204
Middlesex HospitalMiddletown, Connecticut  06457
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Saint Luke's Mountain States Tumor InstituteBoise, Idaho  83712
John H Stroger Jr Hospital of Cook CountyChicago, Illinois  60612-3785
Resurrection HealthcareChicago, Illinois  60631
Evanston CCOP-NorthShore University HealthSystemEvanston, Illinois  60201
Intercommunity Cancer CenterGalesburg, Illinois  61401
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
Community Cancer Center FoundationNormal, Illinois  61761
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Sarah Culbertson Memorial HospitalRushville, Illinois  62681
Edward H Kaplan MD and AssociatesSkokie, Illinois  60076
Saint Margaret's HospitalSpring Valley, Illinois  61362
Fort Wayne Medical Oncology and Hematology Inc - State BoulevardFort Wayne, Indiana  46845
Hematology Oncology Associates-Quad CitiesBettendorf, Iowa  52722
Memorial Hospital of Arkansas CityArkansas City, Kansas  67005
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Radiation Oncology Practice Corporation SouthwestOverland Park, Kansas  66210
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Stormont-Vail Regional Health CenterTopeka, Kansas  66604
Saint Francis Hospital and Medical Center - TopekaTopeka, Kansas  66606
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Beverly HospitalBeverly, Massachusetts  01915
North Shore Medical Center Cancer CenterPeabody, Massachusetts  01960
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Mid-Michigan Medical Center - MidlandMidland, Michigan  48670
Saint Mary's of MichiganSaginaw, Michigan  48601
Lakeland HospitalSt. Joseph, Michigan  49085
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Radiation Oncology Practice Corporation - NorthKansas City, Missouri  64154
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Radiation Oncology Practice Corporation SouthKansas City, Missouri  64114
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Saint Joseph Health CenterKansas City, Missouri  64114
Liberty Radiation Oncology ClinicKansas City, Missouri  64116
Truman Medical CenterKansas City, Missouri  64108
Billings ClinicBillings, Montana  59107-7000
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Portsmouth Regional HospitalPortsmouth, New Hampshire  03802
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington CountyMount Holly, New Jersey  08060
South Jersey HealthcareVineland, New Jersey  08360
Virtua West Jersey Hospital VoorheesVoorhees, New Jersey  08043
The North Division of Montefiore Medical CenterBronx, New York  10466
New York University Langone Medical CenterNew York, New York  10016
Mission Hospitals IncAsheville, North Carolina  28801
Margaret R Pardee Memorial HospitalHendersonville, North Carolina  28791
Kinston Medical Specialists PAKinston, North Carolina  28501
The Boardman Cancer CenterBoardman, Ohio  44512
Aultman Health FoundationCanton, Ohio  44710
Saint Joseph Cancer CenterWarren, Ohio  44484
Saint Elizabeth Hospital Medical CenterYoungstown, Ohio  44501
Natalie W Bryant Cancer CenterTulsa, Oklahoma  74136
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Greenville CCOPGreenville, South Carolina  29615
Sanford Cancer Center-Oncology ClinicSioux Falls, South Dakota  57104
Swedish Medical Center-First HillSeattle, Washington  98122-4307
West Virginia UniversityMorgantown, West Virginia  26506
Langlade Hospital and Cancer CenterAntigo, Wisconsin  54409
Aspirus Regional Cancer CenterWausau, Wisconsin  54401
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
Cedar Valley Medical SpecialistsWaterloo, Iowa  50702
Emerson HospitalConcord, Massachusetts  01742
Elkhart ClinicElkhart, Indiana  46515
University of Colorado Cancer Center - Anschutz Cancer PavilionAurora, Colorado  80045
The Shaw Regional Cancer CenterEdwards, Colorado  81632
Montrose Memorial HospitalMontrose, Colorado  81401
Kootenai Cancer CenterPost Falls, Idaho  83854
Michiana Hematology Oncology PC-South BendSouth Bend, Indiana  46601
Hackensack University Medical CCOPHackensack, New Jersey  07601
Moses Cone Health System-Regional Cancer CenterGreensboro, North Carolina  27403
Annie Penn Memorial HospitalReidsville, North Carolina  27320
Erlanger Medical CenterChattanooga, Tennessee  37403
Aurora Advanced Healthcare Inc-MequonMequon, Wisconsin  53092
Hope, A Women's Cancer CenterAsheville, North Carolina  28816
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida  33136
Saint Luke's South HospitalOverland Park, Kansas  66213
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Forsyth Memorial HospitalWinston-Salem, North Carolina  27103
Gundersen LutheranLa Crosse, Wisconsin  54601
Columbia Saint Mary's Water Tower Medical CommonsMilwaukee, Wisconsin  53211
San Francisco General HospitalSan Francisco, California  94110
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Sanford USD Medical Center - Sioux FallsSioux Falls, South Dakota  57117-5134
Sanford Bismarck Medical CenterBismarck, North Dakota  58501
Geisinger Medical Center-Cancer Center HazeltonHazleton, Pennsylvania  18201
Veterans Administration-San Diego Medical CenterSan Diego, California  92161
Presbyterian Intercommunity HospitalWhittier, California  90602
Saint Anthony Hospital NorthWestminster, Colorado  80030
Illinois CancerCare GalesburgGalesburg, Illinois  61401
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
Saint Joseph Regional Medical Center - MishawakaPlymouth, Indiana  46544
Via Christi Hospital-PittsburgPittsburg, Kansas  66762
Benefis Healthcare-West CampusGreat Falls, Montana  59405
Moorehead Memorial HospitalEden, North Carolina  27288
Essentia Health Cancer Center-South University ClinicFargo, North Dakota  58103
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Group Health Cooperative of Puget Sound Oncology ConsortiumSeattle, Washington  98109
Aurora Cancer Care-BurlingtonBurlington, Wisconsin  53105
Aurora Cancer Care-FranklinFranklin, Wisconsin  53132
Aurora Cancer Care-GlendaleGlendale, Wisconsin  53212
Aurora Cancer Care-Kenosha SouthKenosha, Wisconsin  53142
Aurora Cancer Care-Milwaukee SouthMilwaukee, Wisconsin  53215
Aurora Cancer Care-RacineRacine, Wisconsin  53406-5661
Aurora Cancer Care-WaukeshaWaukesha, Wisconsin  53188
Aurora Cancer Care-Milwaukee WestWauwatosa, Wisconsin  53226