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 |
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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.