Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006030
First received: July 5, 2000
Last updated: August 6, 2013
Last verified: December 2006
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining radiation therapy and tamoxifen with surgery may kill more tumor cells. It is not yet known which treatment regimen is most effective for stage I breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of four different treatment regimens in treating women who have stage I breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: tamoxifen citrate
Procedure: conventional surgery
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Protocol of a Randomized Trial for the Management of Small Well-Differentiated and Special Type Carcinomas of the Breast

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 1992
Detailed Description:

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 study.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 specified

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00006030

Locations
United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Sponsors and Collaborators
British Association of Surgical Oncology: Breast Group
Investigators
Study Chair: R.W. Blamey Nottingham City Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006030     History of Changes
Other Study ID Numbers: BASO-BREAST-BASO-II, CDR0000068043, EU-20019, ISRCTN47734678
Study First Received: July 5, 2000
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on July 20, 2014