IBCSG VIII - Adjuvant therapy in pre- and peri-menopausal patients with node negative breast cancer

Phase 3

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12607000037404
• 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: 1200

Inclusion Criteria

• Node negative disease• Patients must have had:a) Either total mastectomy or breast-conserving procedureb) Axillary clearance with at least 8 lymph nodes for pathological examinationc) The surgical procedure within 6 weeks prior to randomisation• At least 8 lymph nodes histo-pathologically examined• Tumour confirmed to breast with no detected metastases• Adequate marrow function• Documented evidence of adequate renal and hepatic function• Informed consent• Pre- and perimenopausal patients: a) > 52 years, and have had LNMP (last normal menstrual period) within 1 year; orb) < or equal to 52 years, and have had the LNMP within 3 years, or are currently menstruating; orc) < or equal to 55 years and have had hysterectomy without bilateral oophorectomy; ord) Biochemical confirmation of continuing ovarian function

Exclusion Criteria

• Axillary node involvement• Malignant breast tumours other than carcinoma• T4 tumours with ulceration or infiltration of the skin, peau d'orange, or metastatic disease• Bilateral malignancies, or mass in opposite breast, unless mass is proven by biopsy to be non-malignant• Patients who have had less than total mastectomy procedure in which margins of resection contained tumour cells, after which they did not subsequently undergo a total mastectomy • Pregnant at diagnosis or lactating patients (including those who have stopped lactating within past 6 months)• Previous or concurrent malignancy, except patients with squamous or basal cell carcinoma of skin, or adequately treated in-situ carcinoma of cervix• Prior therapy for breast cancer, including irradiation, surgery or chemo- and/or hormonal therapy• Other non-malignant systemic diseases preventing treatment options or prolonged follow-up• Psychiatric or addictive disorders preventing informed consent or treatment options• Bone scan showing hot spots which cannot be confirmed as benign disease or skeletal pain of unknown cause• Older than 45 years who have had a hysterectomy, unless there is chemical proof of ovarian function by all of the following tests: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH), Oestradiol (E2) (Addendum 1 – 1/11/1991)• Estrogen receptor negative tumours or who are estrogen receptor status unknown (Addendum 7 - 1/08/1998)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint for evaluation of therapeutic effect will be disease-free survival (DFS) where all relapses, second primary tumours and death without recurrence are counted as failures.[Patients are followed up and assessed in clinic after every CMF and LH-RH (lutenising hormone-releasing hormone) analogue administration. Follow-up is required ever third month during the first two years, every six months for the next three years and yearly thereafter for life.]