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A Randomized Comparison Of Medroxyprogesterone Acetate (MA) And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen, Phase III


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Endometrial Cancer

Thank you

Trial Information

A Randomized Comparison Of Medroxyprogesterone Acetate (MA) And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen, Phase III


OBJECTIVES:

- Compare endometrial pathologic diagnoses (proliferative changes, simple or cystic
hyperplasia, complex adenomatous hyperplasia, hyperplasia with atypia, and carcinoma)
in postmenopausal women with breast carcinoma treated with adjuvant tamoxifen who are
randomly assigned to medroxyprogesterone acetate (MA) vs observation.

- Compare endometrial pathologic diagnoses (persistent endometrial hyperplasia, atypia,
or carcinoma) resulting in tamoxifen discontinuation and intermittent bleeding in
patients treated with these regimens.

- Characterize the incidence of spontaneous regression and progression of simple or
cystic hyperplasia in these patients.

- Characterize endometrial biopsy results using different endometrial stripe width
cut-off points, for cases in which the width is at least 5 mm by endovaginal ultrasound
in patients receiving tamoxifen.

- Compare changes over time in endometrial oncogene expression (e.g., c-fos, c-jun, p53,
IGF1) and receptor status in patients receiving tamoxifen with or without prior
chemotherapy who are randomly assigned to MA vs observation.

- Describe the associations among change in gene expression, receptor status, endometrial
abnormality, length of tamoxifen exposure, and prior chemotherapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
adjuvant chemotherapy (yes vs no), number of positive nodes (0-3 vs at least 4), and
endovaginal sonogram endometrial stripe (less than 5 mm vs at least 5 mm). Patients are
randomized to 1 of 2 arms.

All patients receive adjuvant oral tamoxifen daily for five years.

- Arm I: Patients undergo observation.

- Arm II: Patients receive oral medroxyprogesterone acetate on days 1-14. Treatment
repeats every 3 months for 5 years.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 330 patients (165 per arm) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- One of the following histologically proven diagnoses:

- Primary invasive adenocarcinoma of the unilateral or bilateral breast

- Stage I, IIA, or IIB (T1-3, N0-1, M0)

- No recurrent invasive breast cancer

- Ductal carcinoma in situ (DCIS)

- Lobular carcinoma in situ (LCIS) with microinvasion

- Paget's disease of the nipple

- No sarcoma, lymphoma, or apocrine, adenocystic, or squamous cell cancer of the breast

- Currently free of breast cancer (no evidence of disease)

- No evidence of distant disease on chest x-ray or chest CT scan and mammogram of
the opposite breast within the past year

- Prior definitive local treatment of primary lesion (mastectomy or breast-sparing
procedure with radiotherapy) and either axillary node or sentinel node biopsy

- Surgical margins clear of both infiltrating carcinoma (any type) and DCIS

- No gross or microscopically positive margins except:

- Invasive cancer or DCIS at the focal margin treated with definitive
radiotherapy

- Gross or LCIS at the final margin

- Biopsy requirement waived for DCIS or LCIS with minimal microinvasion

- Patients with breast-sparing procedure must have received or be planning to receive
radiotherapy at start of tamoxifen treatment

- No endometrial simple or cystic hyperplasia, proliferative changes, complex
(adenomatous) or atypical hyperplasia, or carcinoma

- Patients must be planning one of the following:

- Starting adjuvant tamoxifen for five years OR

- Started tamoxifen within 28 days prior to study and planning to receive adjuvant
tamoxifen for five years

- Hormone receptor status:

- Candidate for adjuvant tamoxifen therapy

PATIENT CHARACTERISTICS:

Age:

- Adult

Sex:

- Female

Menopausal status:

- Postmenopausal defined as:

- At least 1 year since last menstrual period

- At least 2 months since bilateral oophorectomy prior to breast cancer diagnosis

- 4-12 months since last menstrual period and FSH elevated to postmenopausal range

- Postmenopausal estrogen therapy and 55 years of age or older

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Fertile patients must use effective contraception during and for at least 2 months
after study

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer
currently in complete remission

- No concurrent nonmalignant-related illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Adjuvant chemotherapy allowed

- No concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

- No prior hormonal treatment for breast cancer (except tamoxifen)

- No concurrent postmenopausal estrogen therapy

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

- No prior or concurrent hysterectomy

Other:

- No prior or current participation in an adjuvant intergroup trial

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Endometrial pathologic diagnosis

Outcome Description:

Endometrial pathologic diagnosis at 2 years after registration

Outcome Time Frame:

2 years after registration

Safety Issue:

No

Principal Investigator

Ronald K. Potkul, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000065314

NCT ID:

NCT00002920

Start Date:

March 1997

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • Endometrial Cancer
  • endometrial cancer
  • stage I breast cancer
  • stage II breast cancer
  • ductal breast carcinoma in situ
  • lobular breast carcinoma in situ
  • Paget disease of the breast
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Adenoma

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
MBCCOP - HawaiiHonolulu, Hawaii  96813
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Puget Sound Oncology ConsortiumSeattle, Washington  98109
Naval Medical Center - San DiegoSan Diego, California  92134-3202
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Providence Alaska Medical CenterAnchorage, Alaska  99508
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
Broward General Medical CenterFort Lauderdale, Florida  33316
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Cooper University HospitalCamden, New Jersey  08103
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
St. Louis University Hospital Cancer CenterSaint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Veterans Affairs Medical Center - Little RockLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Loma Linda (Pettis)Loma Linda, California  92357
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
Providence Cancer Institute at Providence Hospital - SouthfieldSouthfield, Michigan  48075
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
NorthEast Oncology Associates - ConcordConcord, North Carolina  28025
Arthur G. James Cancer Hospital at Ohio State UniversityColumbus, Ohio  43210-1240
University of Tennessee Cancer Institute at Methodist Central HospitalMemphis, Tennessee  38104
Oncology and Hematology Associates of Southwest Virginia, Incorporated - RoanokeRoanoke, Virginia  24014