Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information
Hormone Therapy in Treating Postmenopausal Women With Receptor-Positive Breast Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Completed | postmenopausal | NCI | E-EB193 CLB-9443, NCCTG-953052, SWOG-9514, INT-0151, NCT00002646 |
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.
Entry 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
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
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
Expected Enrollment
1500A total of 1,500 patients will be accrued for this study over approximately 3 years.
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.Published Results
Rao RD, Cobleigh MA, Gray R, et al.: Phase III double-blind, placebo-controlled, prospective randomized trial of adjuvant tamoxifen vs. tamoxifen and fenretinide in postmenopausal women with positive receptors (EB193): an intergroup trial coordinated by the Eastern Cooperative Oncology Group. Med Oncol 28 (Suppl 1): S39-S47, 2011.
Cobleigh MA, Gray R, Graham M, et al.: Fenretinide (FEN) vs placebo in postmenopausal breast cancer patients receiving adjuvant tamoxifen (TAM), an Eastern Cooperative Oncology Group Phase III Intergroup Trial (EB193, INT-0151). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A328, 2000.
Trial Lead Organizations
Eastern Cooperative Oncology Group
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| Melody Cobleigh, MD, Protocol chair | |
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Southwest Oncology Group
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| George Thomas Budd, MD, Protocol chair | |
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Cancer and Leukemia Group B
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| Mark Graham, MD, Protocol chair (Contact information may not be current) | |
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North Central Cancer Treatment Group
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| James Ingle, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | 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 | |
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| Trial Start Date | 1995-10-04 | |
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| Trial Completion Date | 2004-02-25 | |
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| Registered in ClinicalTrials.gov | NCT00002646 | |
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| Date Submitted to PDQ | 1995-10-04 | |
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| Information Last Verified | 2010-10-06 | |
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| NCI Grant/Contract Number | CA21115, CA31946, CA32102 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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