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

NCT02488967.

Study name Doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin in treating patients with triple‐negative breast cancer
Methods Accrual: recruiting
Accrual target: 782
Multicentre, phase 3 RCT
Trial is being conducted in USA
Blinding: open‐label study
Participants People with node positive or high‐risk node negative triple negative breast cancer
Adjuvant or neoadjuvant: adjuvant
Interventions Arm 1: intervention: doxorubicin then paclitaxel on days 1, 8 and 15 and carboplatin on day 1 every 3 weeks for 4 cycles
Arm 2: comparator: doxorubicin and cyclophosphamide on day 3 every 2 weeks for 4 cycles, followed by paclitaxel day 1 weekly for 12 weeks
Outcomes Primary
  • Disease‐free survival


Secondary
  • Breast cancer‐free survival

  • Distant recurrence‐free interval

  • Adverse events

  • Overall survival

  • Recurrence‐free interval

Starting date Planned start date: July 2015
Estimated completion date: November 2023
Contact information Contact: Vicente Valero (askmdanderson@mdanderson.org)
Notes Trial registration link: clinicaltrials.gov/ct2/show/NCT02488967
Trial sponsor: NRG Oncology
Funding considerations: not provided in trial record