Ando 2014.

Study characteristics
Methods	Accrual: March 2010 and September 2011 Multicentre, 10 centres Phase of trial: 2 Trial design: open‐label RCT Countries: Japan Median follow‐up: 12 months
Participants	Demographics and clinical characteristics were not reported separately for the participants of interest for this Cochrane Review topic. People with TNBC made up approximately 40% of the entire cohort. For entire cohort Age: median 47, range 30–70 years Nodal status of breast cancer: 65% node positive, 35% node negative BRCA mutation: not reported Adjuvant or neoadjuvant: neoadjuvant Notable exclusion criteria: none
Interventions	Arm 1: intervention: carboplatin AUC5 every 3 weeks for 4 cycles + paclitaxel 80 mg/m2 days 1, 8, 15 for 4 cycles, followed by 4 cycles of cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2 and fluorouracil 500 mg/m2 every 3 weeks Arm 2: comparator: paclitaxel 80 mg/m2 days 1, 8, 15 for 4 cycles, followed by 4 cycles of cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2 and fluorouracil 500 mg/m2 every 3 weeks Surgery within 8 weeks after completing neoadjuvant therapy. People who had breast‐conserving therapy received whole breast irradiation
Outcomes	Primary pCR rate, defined as the absence of viable invasive tumour in both the breast and axillary nodes. Residual DCIS in the breast and no invasive tumour in the axillary nodes was also classified as having a pCR Secondary DFS, defined as time from randomisation to the first appearance of any recurrence of breast cancer (local, regional or distant), or any cause of death Clinical response rate, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 Breast conservation rate Safety, assessed using the CTCAE version 4.03 OS (not prespecified endpoint), defined as time from randomisation to death by any cause
Notes	Trial registration record: UMIN000003355. Where reported separately, we extracted data for the TNBC cohort only (42% of entire cohort) for efficacy outcomes. As data were not presented separately for toxicity, we extracted data for the entire cohort. Authors were not contacted. All randomised patients who received ≥ 1 dose of study chemotherapy were included in the analysis. Study did not report assessing the proportional hazards assumption. Funding considerations: carboplatin provided by Bristol‐Myers Squibb. Study supported by Health and Labour Sciences Research Grants, Ministry of Health, Labour and Welfare, Cancer Research & Development and National Cancer Centre grants, Japan.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "patients were randomly assigned to receive either … by the minimization method, with balancing of the treatment arms according to disease status, hormone receptor status and institution." (p. 402)
Allocation concealment (selection bias)	Low risk	"Central registration" listed in trial registration record.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Participants and personnel were aware of treatment allocation. This may have been associated with some performance bias but it was not judged to be of serious concern given types of outcomes collected.
Blinding of outcome assessment (detection bias): DFS	Low risk	Lack of blinding unlikely to influence this outcome.
Blinding of outcome assessment (detection bias): OS	Low risk	Lack of blinding unlikely to influence this outcome.
Blinding of outcome assessment (detection bias): toxicity	Low risk	Toxicity outcomes graded using the CTCAE. Although the study was open‐label, grading symptoms using the CTCAE is standardised and, therefore, knowing treatment allocation may have had minimal effect on the grading of outcomes.
Blinding of outcome assessment (detection bias): neoadjuvant studies only: pCR	Low risk	Evaluated centrally by 3 breast pathologists.
Selective reporting (reporting bias)	Low risk	All outcomes listed in trial registration record were reported in trial publications. OS was not prespecified but collected later on and is a critical outcome for this review topic.
Incomplete outcome data (attrition bias) All outcomes	Low risk	CONSORT diagram (p.404) showed that 2 participants randomised were excluded from analyses due to both participants refusing treatment.
Other bias	Low risk	None identified.