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. 2023 Sep 8;2023(9):CD014805. doi: 10.1002/14651858.CD014805.pub2

Li 2020.

Study characteristics
Methods Accrual: June 2011 to December 2015
Single centre
Phase of trial: 3
Study design: open‐label RCT
Country or countries where the trial was conducted: China
Median follow‐up: 57.3 months
Participants Age: median 49, range 22–64 years
Nodal status of breast cancer: 37% node positive, 63% node negative
Adjuvant or neoadjuvant: adjuvant
Notable exclusion criteria: none
Interventions Arm 1: paclitaxel 150 mg/m2 + carboplatin AUC3 every 2 weeks for 8 cycles
Arm 2: epirubicin 80 mg/m2 and cyclophosphamide 600 mg/m2 every 2 weeks for 4 cycles followed by paclitaxel 175 mg/m2 every 2 weeks for 4 cycles
Outcomes Primary
  • 3‐year DFS rate, defined as the date of randomisation to the date of the first local/distant recurrence (in the absence of other primary malignancies)


Secondary
  • OS, defined as the time from randomisation to death due to any cause

  • Toxicity, according to NCI‐CTCAE, version 3.0

Notes Trial registration record: NCT01378533
All randomised participants were included in analysis.
Study did not report assessing the proportional hazards assumption.
Funding considerations: funded by the National Key Research and Development Program of China and the Chinese Academy of Medical Science Initiative for Innovative Medicine.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Simple randomization was conducted … using random allocation sequence" (p.487) but no details provided as to how random sequence was generated.
Allocation concealment (selection bias) Unclear risk No information provided at single site.
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 involved regular laboratory tests, etc. at the end of each cycle. Therefore, knowing treatment allocation may have had minimal effect on the grading of outcomes.
Selective reporting (reporting bias) Low risk All outcomes listed in trial registration record were reported in trial publication. OS was not prespecified but collected later and was a primary outcome for this review.
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants randomised were included in the analysis irrespective of outcome being measured or treatment actually received.
Other bias Low risk None identified.