PROTOCOL FOR THE SCOTTISH POSTMENOPAUSAL CHEMO-ENDOCRINE TRIAL
N/A
70 Years
Female
Breast Cancer
Trial Information
PROTOCOL FOR THE SCOTTISH POSTMENOPAUSAL CHEMO-ENDOCRINE TRIAL
OBJECTIVES: I. Compare the potential benefits of adjuvant tamoxifen with or without
cyclophosphamide, methotrexate, and fluorouracil (CMF) in postmenopausal women with stage
I-IIIA, unilateral, invasive breast cancer.
OUTLINE: This is a randomized study, multicenter study. Patients are stratified according to
nodal status (positive vs negative or unknown) and hospital region. Patients undergo
surgical resection with or without local radiotherapy, as appropriate. Radiotherapy begins
within 8 weeks of surgery for patients randomized to arm I and within 4 weeks after
completion of chemotherapy for patients randomized to arm II. Patients are randomized to 1
of 2 treatment arms, preferably within 2 weeks after surgery. Arm I: Beginning within 4
weeks after surgery, patients receive oral tamoxifen daily. Treatment continues for 5 years.
Arm II: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and
cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1 (CMF). Chemotherapy
continues every 3 weeks for 6 courses. Patients are followed every 6 months for 5 years and
then annually thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven unilateral, invasive breast cancer Stage
T0-3, N0-1, M0 No evidence of distant disease, including ipsilateral supraclavicular node
enlargement unless proven benign No carcinoma in situ alone, including Paget's disease of
the nipple without underlying invasion No evidence of distant disease, including
ipsilateral supraclavicular node enlargement unless proven benign No history of pure
carcinoma in situ in either breast Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Postmenopausal,
defined by 1 of the following criteria: Last menstrual period more than 1 year before
initial surgery Any age with prior bilateral oophorectomy (for nonmalignant reason) Age 50
and over with prior hysterectomy (for nonmalignant reason) without oophorectomy If at
variance with the above definitions, hormonal assays in postmenopausal range take
precedence Performance status: Not specified Life expectancy: Not specified Hematopoietic:
Not specified Hepatic: Not specified Renal: Not specified Other: No other serious illness
No other prior invasive malignancy except adequately treated basal cell or squamous cell
skin cancer
PRIOR CONCURRENT THERAPY: Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
W.D. George, MD, MS, FRCS
Investigator Role:
Study Chair
Investigator Affiliation:
University of Glasgow
Authority:
United States: Federal Government
Study ID:
CDR0000063696
NCT ID:
NCT00002581
Start Date:
June 1993
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
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