Know Cancer

forgot password


Phase 3
Not Enrolling
Breast Cancer

Thank you

Trial Information


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:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Melody A. Cobleigh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rush University Medical Center


United States: Federal Government

Study ID:




Start Date:

October 1995

Completion Date:

Related Keywords:

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



Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
MBCCOP - University of South Alabama Mobile, Alabama  36688
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Beckman Research Institute, City of Hope Los Angeles, California  91010
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Madigan Army Medical Center Tacoma, Washington  98431-5048
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences University Portland, Oregon  97201-3098
Great Falls Clinic Great Falls, Montana  59405
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209