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. 2019 Feb 18;2019(2):CD012873. doi: 10.1002/14651858.CD012873.pub2

Taghian 2005.

Methods Accrual: February 2000 to March 2005
Multicentre, phase II randomised study conducted in the USA
Neoadjuvant study
Participants Age: mean 47.9 years (SD 9.2) (arm 1); mean 50.4 years (SD 8.2) (arm 2)
Premenopausal: 59.3% (arm 1), 48.3% (arm 2); postmenopausal: 37.0% (arm 1), 44.8% (arm 2)
Clinical T stage: T2 70.4%, T3 29.6% (arm 1); T2 60.0%, T3 40.0% (arm 2)
Clinical N stage: N0 55.6%, N1 44.4% (arm 1); N0 46.7%, N1 53.3% (arm 2)
ER‐positive: 74.1% (arm 1), 73.3% (arm 2); PR‐positive: 77.8% (arm 1), 60.0% (arm 2)
HER2‐positive: 11.1% (arm 1), 30.0% (arm 2)
Interventions Arm 1: paclitaxel (80 mg/m²) every week for 9 cycles followed by doxorubicin (60 mg/m²) every 2 weeks for 4 cycles
Arm 2: doxorubicin (60 mg/m²) every 2 weeks for 4 cycles followed by paclitaxel (80 mg/m²) every week for 9 cycles
Outcomes
  • pCR (only outcome listed in clinical trial record)

  • Interstitial fluid pressure

Notes Clinical trial registry record: NCT00096291
Trial publications state that overall survival data also collected but not reported. Trialists contacted 27 August 2018 asking for overall survival, disease‐free survival and pCR data if available. Trialists replied that they could make data available but required time.
Research contact person: Alphonse Taghian (ATAGHIAN@mgh.harvard.edu)
Funding considerations: supported by Massachusetts Department of Public Health, an Investigator Initiated grant from Bristol‐Myers‐Squibb, Massachusetts General Hospital Cancer Fund, Jane Mailloux Research Fund, NCI Avon Supplement

ER: oestrogen receptor; HER2: human epidermal growth factor receptor 2; pCR: pathological complete response; PR: progesterone receptor; SD: standard deviation.