Roy.

Methods	Randomised controlled trial Open‐label, single institution Computer‐based randomisation procedure, 1:1 Accrual July 2007 to January 2010 Baseline patient and tumour characteristics well balanced
Participants	Female, premenopausal and postmenopausal Median age: 47 years (18 to 66) Operable, unilateral breast cancer, stage II Post modified radical mastectomy with clear surgical margins Axillary node positive: 100% Exclusion of metastatic disease Karnofsky performance status: > 70 HR positive: 60% AC‐T and 58% AC
Interventions	ARM 1 (AC) AC × 6 21‐day cycles (doxorubicin 60 mg/m², cyclophosphamide 600 mg/m²) ARM 2 (AC‐T) AC × 3 21‐day cycles (doxorubicin 60 mg/m², cyclophosphamide 600 mg/m²) followed by T × 3 21‐day cycles (paclitaxel 175 mg/m²) Tamoxifen 20 mg/d for 5 years to women with ER‐ and/or PR‐positive tumours, or tumours with unknown hormone receptor status Surgical treatment of mastectomy All patients given locoregional external beam radiotherapy post chemotherapy
Outcomes	Primary endpoint: Disease‐free survival Secondary endpoints: Toxicity Overall survival
Notes	Median follow‐up: 24 months Trial registry record not found in Clinical Trials Registry ‐ India Funding source: not reported in trial publication For the review update, O‐E and V for OS and DFS derived using Method 3 (Tierney 2007)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "the patient[s] were randomly assigned into two treatment arms by a computer‐based randomization procedure"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Open‐label
Blinding of outcome assessment ‐ OS (detection bias)	Low risk	Assessment of overall survival unlikely to be influenced by no or incomplete blinding
Blinding of outcome assessment ‐ DFS & Toxicity (detection bias)	Unclear risk	Mammography, CXR, and in patients receiving tamoxifen, pelvic and rectal examination with Pap smear performed annually. Examination and evaluation before the start of each chemotherapy cycle; CBC, liver and kidney function tests. Follow‐up performed 3 weeks after chemotherapy, then 2 monthly for the first year, followed by 3 monthly until end of the study. LVEF evaluated at baseline and at 18 months Comment: no involvement of an independent adjudication committee for outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "there was no loss of patients in any of the arms due to 'lost to follow‐up'"
Selective reporting (reporting bias)	Low risk	Outcomes specified in the methods and results sections of the trial publication consistent. No trial registry or protocol found on Clinical Trials Registry ‐ India
Other bias	Unclear risk	Baseline patient and tumour characteristics appearing well balanced, excluding tumour status with 28% T2 and 44% T3 in AC‐T treatment group vs 44% T2 and 24% T3 in AC treatment group