Adjuvant Cytotoxic Chemotherapy in Older Women - ACTIO

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Age 70 years or over of either sex;
•Performance status 0 or 1;
•Histological diagnosis of invasive breast carcinoma;
•Primary operable breast cancer surgically treated by wide local excision or mastectomy with clear margins (>1mm apart from deep margin if full thickness resection).
•Axillary staging performed by sentinel node biopsy, axillary sampling or clearance. All nodepositive patients must have had axillary clearance or radiotherapy to the axilla (see appendix 2);
•High risk of relapse (approx 30%). This will include any patient with HER2 positive disease, or ER negative disease. High risk ER positive disease would typically be expected to be grade 3 with 4+ positive nodes. Other ER positive patients may be considered on a individual basis
•Early stage disease with no evidence of metastases clinically or on routine staging investigations;
•High risk of relapse within 5 years (risk factors evaluated at clinicians discretion)
•Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic, and renal function i.e.
•Hb > 9g/dL; WBC > 3 ? 109/L; platelets > 100 x 109/L;
•Bilirubin within normal range (unless known Gilbert’s disease);
•AST/ALT = 1.5 x Upper limit of normal (ULN);
•Albumen within normal range;
•Creatinine = 1.5 x ULN and calculated creatinine clearance using Cockroft-Gault formula > 50 ml/min; and
•No active, uncontrolled infection;
•Written informed consent given;
•No previous anthracycline chemotherapy at any time, and no other systemic anti cancer therapy within the last 5 years, unless exposure to treatment is brief, and in the context of a peri-operative trial with biological endpoints.
•No previous mantle radiotherapy
•Randomisation as soon as reasonably possible after definitive surgery, ideally within 8 weeks and
•Patient available for routine long term hospital follow-up

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previous invasive breast cancer within the last 5 years;
•Previous DCIS within the last 5 years if treated systemically;
•Any previous haematological malignancy or melanoma;
•Any previous solid tumours within the last 5 years;
•Primary inoperable breast cancer (T4 and/or N3 disease);
•Patients who have had breast conserving surgery in whom there is a contra-indication for, or decline of, post-operative radiotherapy;
•Patients with significant cardiac disease as determined by MUGA or ECHO (LVEF < 55% excluded) or
•Patients not able or willing to give informed consent.