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

Gigolaeva 2019.

Study characteristics
Methods Accrual: not reported
Single centre
Phase of trial: not reported
Study design: RCT
Country or countries where the trial was conducted: Russia
Median follow‐up: not reported
Participants Age: median 47, range 32–62 years
Nodal status of breast cancer: not reported
Adjuvant or neoadjuvant: neoadjuvant
Notable exclusion criteria: not reported
Interventions Arm 1: doxorubicin 60 mg/m2 + cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles followed by carboplatin AUC2 weekly + eribulin 1.4 mg/m2 OR paclitaxel 175 mg/m2 every 3 weeks for 12 weeks
Arm 2: doxorubicin 60 mg/m2 + cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles followed by paclitaxel 80 mg/m2 for 12 weeks
Outcomes Primary
  • pCR, according to Miller‐Payne grading system (i.e. grade 5 where no malignant cells were identified at the site of the tumour, DCIS may be present)


Secondary: none reported
Notes Trial registration record could not be found.
Abstract only available. Full article has not yet been published.
Contact details for the authors could not be found to request an update on results or published works.
Funding considerations: "no significant conflicts of interest" (p.S70) declared in the abstract.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "A randomized prospective study" … "randomization (2:1)."
No additional details were provided in the abstract.
Allocation concealment (selection bias) Unclear risk Method of concealment was not described in the abstract.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No information provided in the abstract.
Blinding of outcome assessment (detection bias): neoadjuvant studies only: pCR Unclear risk No information provided on tests used or process to evaluate response.
Selective reporting (reporting bias) Unclear risk Unable to assess from the abstract. A trial registration record could not be found.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No reporting of attrition or exclusions in the available abstract.
Other bias Unclear risk Unable to assess from the abstract.