None listed
Conditions
Brief summary
IBCSG VIII is a randomised clinical trial designed to test the therapeutic role of short duration ovarian function suppression (using Zoladex) in pre-/perimenopausal patients with node negative breast cancer.
Interventions
Arm B: Luteinising hormone- releasing hormone (LH-RH) analogue - Zoladex (3.6 mg subcutaneous injection every 28 days) x 24 months
Arm C: CMF x 6 months (Cyclophosphamide (100mg/m^2 orally days 1-14), Methotrexate (40mg/m^2 iv – days 1 & 8) and 5-Fluorouracil (600mg/m^2iv – days 1 & 8))
Arm D: CMF x 6 months (Cyclophosphamide (100mg/m^2 orally days 1-14), Methotrexate (40mg/m^2 iv – days 1 & 8) and 5-Fluorouracil (600mg/m^2 iv – days 1 & 8)) followed by LH-RH analogue (Zoladex – 3.6 mg subcutatn
Arm B: Luteinising hormone- releasing hormone (LH-RH) analogue - Zoladex (3.6 mg subcutaneous injection every 28 days) x 24 months Arm C: CMF x 6 months (Cyclophosphamide (100mg/m^2 orally days 1-14), Methotrexate (40mg/m^2 iv – days 1 & 8) and 5-Fluorouracil (600mg/m^2iv – days 1 & 8)) Arm D: CMF x 6 months (Cyclophosphamide (100mg/m^2 orally days 1-14), Methotrexate (40mg/m^2 iv – days 1 & 8) and 5-Fluorouracil (600mg/m^2 iv – days 1 & 8)) followed by LH-RH analogue (Zoladex – 3.6 mg subcutatneous injection every 28 days) x 18 months
Sponsors
International Breast Cancer Study Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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)
Outcome results
None listed