Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer

Launched by INSTITUTE OF CANCER RESEARCH, UNITED KINGDOM · Jul 7, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Estimate overall and relapse-free survival of women with early-stage breast cancer receiving adjuvant tamoxifen with or without adjuvant chemotherapy and/or ovarian suppression.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and choice of randomization option.

Postmenopausal women are randomized to the first or second groups.

Randomization for pre- and perimenopausal women is based on the clinician's judgement of appropriate adjuvant therapy (chemotherapy and/or ovarian suppression). Patients may be randomized as foll...

Gender

FEMALE

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed invasive carcinoma of the breast for which adjuvant systemic therapy is appropriate
• • Stage I, II, or IIIA
• • Pathologically positive or negative nodes
• • Any size primary tumor
• • No edema, peau d'orange, infiltration of the skin, or direct extension to the chest wall
• * Hormone receptor status:
• • Not specified
• PATIENT CHARACTERISTICS:
• Age:
• • Not specified
• Sex:
• • Female
• Menopausal status:
• • Pre-, peri-, or postmenopausal
• Performance status:
• • Not specified
• Hematopoietic:
• • Not specified
• Hepatic:
• • Not specified
• Renal:
• • Not specified
• Other:
• * No prior malignancy except:
• • Basal cell carcinoma
• • Carcinoma in situ of the cervix
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • See Disease Characteristics
• Chemotherapy:
• • See Disease Characteristics
• Endocrine therapy:
• • See Disease Characteristics
• Radiotherapy:
• • Not specified
• Surgery:
• • Not specified
• Other:
• • No prior systemic treatment for breast cancer