Study | Latest update | Type of trial (Registry number) | Enrollment period | Age Range (year) | Definition of TNBC | Chemo-regimen -Control arm -X arm | TNBC NO. -Control arm -X arm | Capecitabine dosage | TNM stage | Initial situation of patients | Median follow-up |
---|---|---|---|---|---|---|---|---|---|---|---|
USO 01062 | 2015 | RCT (NCT00089479) | 2002.8–2006.2 | 18–70 | ER-, PR-, HER2- | -4 AC-4 T -4 AC-4 TX | −384 − 396 | 825 mg/m2, bid, d1–14, q21d | T1–3N1–2, or T1c-4 N0, M0 | Unselected | 5.0y |
GEICAM/2003 | 2015 | RCT (NCT00129389) | 2004.2–2007.2 | 18–70 | ER-, PR-, HER2- | -4EC-4 T -4ET-4X | − 71 − 95 | 1250 mg/m2, bid, d1–14, q21d | T1–3N1–3, M0 | Unselected | 6.6y |
FinXX | 2017 | RCT (NCT00114816) | 2004.1–2007.5 | 18–65 | ER-, PR-, HER2- | -3 T-3CEF -3TX-3CEX | − 109 − 93 | 900 mg/m2, bid, d1–15, q21d | N1–3, or T2-4N0, M0 | Unselected | 10.3y |
CREATE-X | 2017 | RCT (UMIN000000843) | 2007.2–2012.7 | 20–74 | ER-, PR-, HER2- | -standard NACT -standard NACT +  6-8X | −147 − 139 | 1250 mg/m2, bid, d1–14, q21d | T1-4N0–2, M0 | Screening from NACT | 5.0y |
CIBOMA/2004 | 2019 | RCT (NCT00130533) | 2006.10–2011.9 | 20–82 | ER-, PR-, HER2- | -standard CT -standard CT + 8X | −428 − 448 | 1000 mg/m2, bid, d1–14, q21d | N1–3, or T1c-4aN0, M0 | Unselected | 7.3y |
CBCSG-010 | 2020 | RCT (NCT01642771) | 2012.6–2013.12 | 18–70 | ER/PR < 10%+, HER2- | -3 T-3CEF -3TX-3CEX | − 288 − 297 | 1000 mg/m2, bid, d1–14, q21d | N1–3, or T1c-4aN0, M0 | Unselected | 67 months |
SYSUCC-001 | 2020 | RCT (NCT01112826) | 2010.4–2016.12 | 24–70 | ER-, PR-, HER2- | -standard CT -standard CT + X(1 year) | −213 − 221 | 650 mg/m2, bid, without interruption | T1b-3 N0-3c, M0 | Unselected | 61 months |