Know Cancer

or
forgot password

PHASE III DOUBLE-BLIND, PLACEBO-CONTROLLED, PROSPECTIVE RANDOMIZED COMPARISON OF ADJUVANT THERAPY WITH TAMOXIFEN VS. TAMOXIFEN AND FENRETINIDE IN POSTMENOPAUSAL WOMEN WITH INVOLVED AXILLARY LYMPH NODES AND POSITIVE RECEPTORS


Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

PHASE III DOUBLE-BLIND, PLACEBO-CONTROLLED, PROSPECTIVE RANDOMIZED COMPARISON OF ADJUVANT THERAPY WITH TAMOXIFEN VS. TAMOXIFEN AND FENRETINIDE IN POSTMENOPAUSAL WOMEN WITH INVOLVED AXILLARY LYMPH NODES AND POSITIVE RECEPTORS


OBJECTIVES: I. Compare disease free survival and overall survival of postmenopausal women
with stage II or IIIA breast cancer treated with tamoxifen (TMX) and fenretinide (HPR) vs
TMX and placebo. II. Gain wider experience in the use and toxicity of combined TMX/HPR in
these patients. III. Obtain tumor tissue samples, as feasible, from these patients for
future biologic studies.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified by participating institution, age (under 70 vs 70 and over), node dissection
(yes vs no), number of involved nodes (0 vs 1-3 vs 4 or more), and number of removed nodes
(1-5 vs 6 or more). All patients receive oral tamoxifen daily for at least 5 years,
beginning immediately after randomization. Patients also receive either oral fenretinide or
oral placebo daily for 5 years, beginning within 2 weeks after completion of any
radiotherapy, or within 2 weeks of randomization, if no radiation. Patients are followed
during and after treatment every 4 months for 2 years, every 6 months for 3 years, then
annually thereafter.

PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for this study over
approximately 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Pathologic
stage T1-3, N1-2, M0 No clinical or pathologic T4 disease No primary tumor fixed to chest
wall No axillary nodes fixed to chest wall or neurovascular bundle No preoperative arm
edema No clinical skin involvement (microscopic focal dermal invasion or dermal lymphatic
involvement eligible) No clinical N2 disease Modified radical mastectomy or lumpectomy
required prior to entry Sentinel node biopsy allowed Randomization required within 12
weeks from definitive surgery Surgery dated from mastectomy or axillary dissection for
lumpectomy No positive deep mastectomy margins Radiotherapy planned within 12 weeks
following axillary node dissection for lumpectomy patients Synchronous bilateral breast
cancer eligible If tumor is at least 2 cm, then nodes not involved If no tumor is at least
2 cm, then at least 1 node must be involved Both invasive primaries receptor-positive
Previously treated, noninvasive breast cancer eligible No prior invasive breast cancer No
adenoid cystic, squamous, or sarcomatous histology Hormone receptor status: Estrogen- or
progesterone-receptor positive, i.e.: At least 10 fmole/mg cytosol protein by
ligand-binding assay OR Receptor positive by immunocytochemistry

PATIENT CHARACTERISTICS: Age: 65 and over OR Postmenopausal and ineligible/inappropriate
for or declined other active node positive adjuvant studies Sex: Female Menopausal status:
Postmenopausal, defined as: At least 1 year since last menstrual period Hysterectomized
with bilateral oophorectomy Hysterectomized with 1 or both ovaries remaining and either:
Over 60 FSH in postmenopausal range Not surgically castrated, under 60, and on HRT FSH
elevated 2 weeks after HRT discontinued Performance status: Not specified Life expectancy:
At least 7 years except for breast cancer Hematopoietic: WBC greater than 3,000/mm3
Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no
greater than 1.5 mg/dL AST less than 2 times normal Renal: Creatinine no greater than 2.0
mg/dL BUN no greater than 25.0 mg/dL Other: No extensive macular degeneration on exam
within 1 year of entry, e.g.: No exudative or atrophic macular lesions that reduce
corrected vision to less than 20/40 Health adequate for protocol treatment No nutritional
supplementation except single daily multivitamin No other vitamin A supplements
Gynecologic exam within the past year required of women who retain a uterus No second
malignancy within the past 10 years except: Inactive nonmelanomatous skin cancer Carcinoma
in situ of the cervix Prior noninvasive contralateral breast cancer

PRIOR CONCURRENT THERAPY: No prior chemotherapy or hormonal therapy for breast cancer
except: Up to 1 month of tamoxifen if started by a non participating physician At least 2
weeks since hormone replacement therapy No concurrent megestrol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Melody A. Cobleigh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rush University Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000064156

NCT ID:

NCT00002646

Start Date:

October 1995

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
MBCCOP - University of South AlabamaMobile, Alabama  36688
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Beckman Research Institute, City of HopeLos Angeles, California  91010
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
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 - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
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
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Great Falls ClinicGreat Falls, Montana  59405
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209