IBCSG 14-93 - Adjuvant therapy for post/peri menopausal patients with node positive breast cancer who are not suitable for endocrine therapy alone

Phase 3

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12607000034437
• Lead Sponsor: International Breast Cancer Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1994-05-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 760

Inclusion Criteria

• Post/perimenopausal women with histologically proven primary breast cancer• Positive lymph nodes (metastases detected in one or more of at least 8 ipsilateral axillary nodes examined). Primary tumour must be classified as T1a,b,c ,T2 or T3, pN1, M0.• Patients must be judged not suitable for treatment with endocrine therapy alone. Estrogen receptor status must be known before randomisation• Patients must have had:a) Either total mastectomy or breast conserving procedureb) Axillary clearance with at least 8 lymph nodes available for pathological examinationc) Primary breast cancer surgical procedure must be within 6 weeks prior to randomisation• Tumour must be confined to breast without detected metastases other than those within lymph nodes• Adequate marrow function (WBC > 4.0 x 10^9/l and platelet count > 100 x 10^9/l)• Adequate renal function (serum creatinine < 120umol/l) and hepatic function (serum bilirubin < 20 umol/l, AST (SGOT) < 60 i.u./l)• Informed consent• Geographically accessible for follow-up

Exclusion Criteria

• Patients without axillary node involvement• Malignant tumours other than carcinoma• T4 carcinoma with ulceration of skin, infiltration of skin, peau d'orange or inflammatory breast cancer or with distant metastases• Bilateral malignancies, or with mass in opposite breast• Patients in whom the margins of the resected specimen contained tumour cells• Previous or concomitant other malignancy except basal or squamous cell carcinoma of skin or adequately treated in situ carcinoma of cervix• Patients who have received prior therapy for breast cancer including irradiation, chemotherapy or endocrine therapy• Patients with non-malignant systemic diseases preventing them from undergoing any of the treatment options or prolonged follow-up• Patients with psychiatric or addictive disorders preventing them from giving them informed consent• Bone scan showing hot spots which cannot be confirmed as benign disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified