IBCSG 12-93 - Adjuvant therapy for post/perimenopausal patients with node positive breast cancer who have oestrogen receptor positive tumours
- Conditions
- Breast CancerCancer - Breast
- Registration Number
- ACTRN12606000532505
- Lead Sponsor
- International Breast Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 960
Post/perimenopausal women - Patients with positive lymph nodes (metastases detected in one or more of at least 8 ipsilateral axillary nodes examined)- Patients must be judged suitable for treatment with endocrine therapy alone. As a minimum, patients must have estrogen receptor positive tumours. (ER >= 10 fmol/mg cytosol protein or judged to be ER positive by immunohistochemical evaluation)- Patients must have had:a) Either total mastectomy or, optionally if the tumour was <= 5cm, a breast-conserving procedure (lumpectomy or quadrantectomy) b) Axillary clearance (not sampling) with at least eight lymph nodes available for pathological examinationc) The primary breast cancer surgical procedure within six weeks prior to randomisation- Minimum of eight lymph nodes histopathologically examined with at least one found positive- Tumour confined to the breast with no detected metastases - Adequate bone marrow function (WBC >= 4.0 x 10^9/L and platelets >+ 100 x 10^9/L)- Documented evidence of adequate renal function (creatinine < 120umol/L) and hepatic function (bilirubin <20umol/L, AST (SGOT) < 60 i.u./L)- Informed consent - Geographically accessible for follow-up
Patients without axillary node involvement- Malignant breast tumours other than carcinoma- T4 carcinoma with ulceration, infiltration of the skin, peau d'orange or inflammatory breast cancer, or with distant metastases- Bilateral malignancies, or mass in opposite breast- Margins of resected specimen contained tumour cells- Estrogen-receptor negative 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- Other non-malignant systemic disease 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival[Followed 12 monthly from randomisation until death.];Disease-free and systemic disease-free survival[Followed every 12 months from randomisation until recurrence or death from any cause.]
- Secondary Outcome Measures
Name Time Method Quality of life[Assessed 3 monthly in year 1, 6 monthly in year 2 and then annually thereafter until year 6 from randomisation.];Toxicity[Assessed at the conclusion of each cycle of chemotherapy treatment and up until 30 days after the last dose date.]