IBCSG 13-93 - Adjuvant therapy for premenopausal patients with node positive breast cancer who are not suitable for endocrine therapy alone

Phase 3

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12607000035426
• 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: 900

Inclusion Criteria

• Premenopausal women (aged 18 or over) 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 of inflammatory breast cancer, or with distant metastases.• Bilateral malignancies, or mass in opposite breast, unless mass has been proven by biopsy to be benign• Patients in whom margins of resected specimen contained tumour cells• Previous or concomitant other malignancy except basal or squamous cell carcinoma of skin or in situ carcinoma of cervix• Prior therapy for breast cancer including prior radiation, chemotherapy or endocrine therapy• Non-malignant systemic diseases preventing treatment options or follow-up• Psychiatric or addictive disorders preventing informed consent• Bone scan showing hot spots which cannot be confirmed as benign disease• Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival[Patients are assessed by clinicians for progression of disease 3 monthly during years 1 – 2, 6 monthly during years 3-5 and then annually until death.]

Secondary Outcome Measures

Name	Time	Method
Overall survival[Patients are assessed by clinicians for the secondary endpoints 3 monthly during years 1 – 2, 6 monthly during years 3-5 and then annually until death.];Sites of relapse[Patients are assessed by clinicians for the secondary endpoints 3 monthly during years 1 – 2, 6 monthly during years 3-5 and then annually until death.];Treatment related side effects[Patients are assessed by clinicians for the secondary endpoints 3 monthly during years 1 – 2, 6 monthly during years 3-5 and then annually until death.];Quality of life[Measured 3 monthly during the first year, 6 monthly during year 2 and annually thereafter until year 6.]