IBCSG 11-93 - Adjuvant therapy for premenopausal patients with node positive breast cancer who are suitable for endocrine therapy alone

Phase 3

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12606000534583
• 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: 1994-11-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

• Premenopausal women with histologically proven primary breast cancer• Positive lymph nodes (metastases detected in 1 or more of at least 8 ipsilateral axillary nodes examined). The primary tumour must be classified as T1a,b,c T2 or T3, pN1, M0 (UICC 1987)• Patients must be judged suitable for treatment with endocrine therapy alone. As a minimum, must have ER positive tumours (ER>= 10 fmol/mg cytosol protein) or PR positive tumours (PgR>= 10 fmol/my cytosol protein)• Patients must have had:a) Either total mastectomy or, optionally if the tumour is <=5cm, breast-conserving procedure (lumpectomy or quadrantectomy)b) Axillary clearance with at least eight lymph nodes available for pathological examinationc) The primary breast cancer surgical procedure must be within 6 weeks prior to randomisation• Minimum of 8 lymph nodes histopathologically examined with at least one found positive• Tumour must be confined to breast without detected metastases• Adequate marrow function (WBC >= 4.0 x 10^9/L and platelet count >= 100 x 10^9/L)• Adequate renal function (serum creatinine < 120 umol/L) and hepatic function (serum bilirubin < 20umol/L, AST (SGOT) < 60 i.u./L)• Informed consent• Geographically accessible for follow-up

Exclusion Criteria

• Patients without axillary node involvement• Malignant breast tumours other than carcinoma• T4 carcinoma with ulceration, infiltration of skin, peau d'orange or inflammatory breast cancer• Bilateral malignancies, or mass in opposite breast• Margins of resected specimen contained tumour cells• ER- and PR- tumours• Previous or concomitant other malignancy except basal or squamous cell carcinoma of skin or in situ carcinoma of cervix• Prior therapy for breast cancer• Non-malignant systemic diseases preventing treatment options or follow-up• Psychiatric or addictive disorders preventing informed consent• Bone scans showing hot spots which cannot be confirmed as benign disease• Pregnant or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival[Patients are followed at each chemotherapy cycle and 3 monthly in the first year, 6 monthly years 2-5 and yearly thereafter for life.];Disease-free and systemic disease-free survival[Patients are followed at each chemotherapy cycle and 3 monthly in the first year, 6 monthly years 2-5 and yearly thereafter for life.]

Secondary Outcome Measures

Name	Time	Method
Quality of life[Assessed 3 monthly in the first year, 6 monthly in year 2 and annually thereafter to year 6.];Toxicity[Assessed at the conclusion of each cycle of treatment up to 30 days after the last dose date.]