NCT03168880.

Study name	A randomized controlled trial of neoadjuvant weekly paclitaxel versus weekly paclitaxel plus weekly carboplatin in women with large operable or locally advanced, triple negative breast cancer (TNBC)
Methods	Accrual: active, not recruiting Accrual target: 720 Single‐centre, phase 3 RCT Trial is being conducted in India Blinding: open‐label study
Participants	People with clinical staging T4, N0‐3, M0 or T1‐4, N2‐3, M0 and T3, N1, M0 with triple negative hormone status Adjuvant or neoadjuvant: neoadjuvant
Interventions	Arm 1: intervention: paclitaxel 100 mg/m2 weekly for 8 weeks followed by carboplatin AUC2 weekly and doxorubicin 60 mg/mg2 or epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 every 3 weeks Arm 2: comparator: paclitaxel 100 mg/m2 weekly for 8 weeks followed by doxorubicin 60 mg/mg2 or epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 every 3 weeks
Outcomes	Primary Disease‐free survival Overall survival Secondary Response rate
Starting date	Planned start date: April 2010 Estimated completion date: 30 November 2024
Contact information	Contact: Rajendra A Badwe (no contact details provided)
Notes	Trial registration link: clinicaltrials.gov/ct2/show/NCT03168880 Trial sponsor: Tata Memorial Hospital Funding considerations: not specified in trial record