Phase III Randomized Study of Adjuvant Therapy With Tamoxifen vs Endocrine Ablation vs Tamoxifen Plus Endocrine Ablation vs No Adjuvant Therapy in Patients Under Age 50 With Operable Breast Cancer
N/A
49 Years
Female
Breast Cancer
Trial Information
Phase III Randomized Study of Adjuvant Therapy With Tamoxifen vs Endocrine Ablation vs Tamoxifen Plus Endocrine Ablation vs No Adjuvant Therapy in Patients Under Age 50 With Operable Breast Cancer
OBJECTIVES: I. Determine, in a prospective, randomized, controlled trial whether the
administration of a course of adjuvant tamoxifen or ablation of ovarian function results in
prolongation of time to recurrence or death in patients under 50 years of age with operable
carcinoma of the breast. II. Determine how hormone manipulation affects mood and sexual
functioning in these patients.
OUTLINE: This is a randomized study. Patients are stratified by clinician. All patients are
randomized following primary therapy, which, in addition to surgery, may include local
irradiation, perioperative cyclophosphamide, or up to 6 cycles of cyclophosphamide,
methotrexate, and fluorouracil (CMF) for high-risk patients. Clinicians may elect to
randomize patients to all groups or to only those groups including tamoxifen. The first
group receives no further therapy. Then second group receives tamoxifen daily for at least 2
years. The third group receives ovarian ablation with goserelin via monthly injection for at
least 2 years. The final group receives ovarian ablation with goserelin plus daily tamoxifen
for at least 2 years. All patients are followed every 3 months for 2 years, every 6 months
for 3 years, then annually.
PROJECTED ACCRUAL: 800 to 1,000 patients will be entered.
Inclusion Criteria
DISEASE CHARACTERISTICS: Operable, clinical Stage I/II breast cancer (T1-3, N0-1, M0) No
evidence of distant metastases on x-ray of chest, spine, and pelvis Bone scan evidence
alone of secondary mass allowed unless considered unequivocal evidence of metastasis No
primary carcinoma fixed to underlying muscle or chest wall No deeply fixed axillary nodes
No ulceration, skin infiltration, or peau d'orange involving more than 1/3 of breast No
bilateral tumors Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Under 50 Sex: Women only Menopausal status: Any status
Performance status: Not specified Life expectancy: No limits on life expectancy due to
intercurrent illness Hematopoietic: WBC at least 3,000 Platelets at least 90,000
Hemoglobin at least 10 g/dL Hepatic: Normal liver function required Renal: Normal kidney
function required Other: Fit for surgery No prior treatment for other malignancies except:
Nonmelanomatous skin cancer Cone-biopsied in situ carcinoma of the cervix English-speaking
patients eligible for quality-of-life assessments
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Chemotherapy for
high-risk patients allowed at the discretion of the clinician Endocrine therapy: At least
6 weeks since prior hormonal therapy No concomitant hormonal therapy including oral
contraceptives (patients must discontinue the pill for 2 years) Radiotherapy: Not
specified Surgery: Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Michael Baum, MD, ChM, FRCS
Investigator Role:
Study Chair
Investigator Affiliation:
University College London Hospitals
Authority:
United States: Federal Government
Study ID:
CDR0000075539
NCT ID:
NCT00002460
Start Date:
September 1987
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
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