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Protocol of a Randomized Trial for the Management of Small Well-Differentiated and Special Type Carcinomas of the Breast

Phase 3
70 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Protocol of a Randomized Trial for the Management of Small Well-Differentiated and Special Type Carcinomas of the Breast

OBJECTIVES: I. Compare the effectiveness of wide local excision alone versus wide local
excision followed by radiotherapy with or without tamoxifen versus wide local excision plus
tamoxifen in women with stage I breast cancer. II. Assess local occurrence in the treated
breast, regional recurrence, distant recurrence, death from breast cancer, and occurrence of
cancer in the opposite breast in these patients when treated with one of these regimens.

OUTLINE: This is a randomized study. Patients are randomized to one of four treatment arms.
All patients undergo wide local excision of the tumor and axillary node dissection. Arm I:
Patients undergo surgery only. Arm II: Patients undergo surgery followed by 25-35
radiotherapy treatments. Arm III: Patients undergo surgery plus oral tamoxifen daily for 5
years. Arm IV: Patients undergo surgery followed by 25-35 radiotherapy treatments and oral
tamoxifen daily for five years. Patients are followed every 3 months for 2 years, and then
every 6 months thereafter.

PROJECTED ACCRUAL: A total of 1200 patients (300 per treatment arm) will be accrued for this

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed unilateral stage I invasive breast
cancer No more than 1 tumor and no greater than 2 cm Grade 1 tumor of any histological
type OR No special type OR Mixed type allowed No lymph node involvement No in situ
carcinoma only or ductal carcinoma in situ with microinvasion No vascular invasion No
Paget's disease of the nipple Well differentiated special type of primary mammary
carcinoma including: Tubular Tubular/cribriform Cribriform Papillary Mucoid No lobular,
medullary, or other rarer types of mammary carcinomas including: Adenoid cystic Carcinoid
Secretory Spindle cell Apocrine No distant metastases Hormone receptor status: Not

PATIENT CHARACTERISTICS: Age: Under 70 Sex: Female Menopausal status: Not specified
Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not
specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No
other systemic disease that may preclude study No other prior malignancy except adequately
treated basal cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: No other concurrent adjuvant systemic therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

R.W. Blamey

Investigator Role:

Study Chair

Investigator Affiliation:

Nottingham City Hospital


United States: Federal Government

Study ID:




Start Date:

January 1992

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • Breast Neoplasms