. 2021 Feb 1;15:1178. doi: 10.3332/ecancer.2021.1178

Table 2. Results of phase II–III clinical trials evaluating the addition of Cb to NACT schemes in TNBC. Literature review, last 10 years.

Study type	n	CT schedule	n arm	pCR% ypT0N0	p value	DFS HR (CI)	OS HR (CI)	Observations
PHASE II
Alba et al [15] GEICAM/2006-03 2012	94	EC-D+Cb^a	48	29.8	0.61	-	-	-
Alba et al [15] GEICAM/2006-03 2012	94	EC-D	46	30.5	0.61	-	-	-
Ando et al [21] 2014	75	TCb-FEC^b	37	0 61a	0.003	-	-	Subgroup analysis for TN
Ando et al [21] 2014	75	T-FEC	38	26	0.003	-	-	Subgroup analysis for TN
Von Minckwitz et al [17] GeparSixto 2014	315	TLA Cb+B^c	158	53^a	0.005	0·56^a (0.34–0.93)	0.60 (0.32–1.12)	47 months follow up showed increase in DFS for Cb use with no differences regarding BRCA status
Von Minckwitz et al [17] GeparSixto 2014	315	TLA+B	157	37	0.005	0·56^a (0.34–0.93)	0.60 (0.32–1.12)
Sikov et al [17] CALGB/ALLIANCE 2016	218	TCb-AC^d	111	54^a	0.003	0.84 (0.58–1.22)	1.15 (0.74–1.79)	39 months follow up showed no survival benefits for Cb group. Improved OS for pCR
		TCb-AC TB-AC
		T-AC	107	41
Zhang et al [34] 2016	91	TCb^e	47	38.6^a	0.014	-	-	55 months follow up showed a 21% benefit in 5 years DFS with Cb (p = 0.043)
Zhang et al [34] 2016	91	ET	44	14	0.014	-	-
Gluz et al [35] WSG-ADAPT-TN 2018	336	Nab-P+Cb^f	154	45.9^a	0.002	-	-	No anthracyclines used
Gluz et al [35] WSG-ADAPT-TN 2018	336	Nab-P+Gem	182	27.8	0.002	-	-	No anthracyclines used
PHASE III
Loibl et al [20] BrighTNess 2018	318	TCb-AC^g	160	58^a	0.0001	-	-	No differences for BRCA status
		TCbV-AC
		T-AC	158	31
Schmid et al [27] Keynote 522 2020	1,174	TCb-AC+Pem^g	784	65	0.0001	0.63^a (0.43–0.93)	-	Both arms used Cb
Schmid et al [27] Keynote 522 2020	1,174	TCb-AC^g	390	51	0.0001	0.63^a (0.43–0.93)	-	Both arms used Cb

TN; Triple negative, CT; Chemotherapy, AUC; Area under de curve, pCR; Pathological complete response, OS, Overall survival, DFS: Disease-free survival, DDFS; Distant disease-free survival, DHR; Deficient homologous recombination, E; Epirubicin, C; Cyclophosphamide, D; Docetaxel, T; Paclitaxel, B; Bevacizumab, Cb; Carboplatin, F; Fluorouracil, Nab-P; Nab-paclitaxel, G; Gemcitabine, V; Veliparib, Pem; Pembrolizumab, A; Doxorubicin, LA; non PEGylated liposomal doxorubicin

E 90 mg/m² + C 600 mg/m² q3w × 4→D 75 mg/m² + Cb AUC (6 mg/mL)

T 80 mg/m² qw × 12 + Cb AUC 5 q3w × 4→ FEC: F 500 mg/m² − E 100 mg/m² − C 500 mg/m² q3w × 4

T 80 mg/m² qw + LA 20 mg/m² qw +/− Cb AUC 2 qw × 18w + B 15 mg/kg q3w × 6

T 80 mg/m² qw ×12 +/− Cb AUC6 q3w ×4→A 60 mg/m² + C 600 mg/m² q2w × 4

T 175 mg/m² on day 1 + Cb AUC5 on day 2 (q3w) or E 75 mg/m² on day 1

A Nab-T 125 mg/m² + Cb AUC2 day 1, 8 q3w or G 1,000 mg/m² dL, 8 three times weekly (q3w)

T 80 mg/m² qw ×12+/− Cb AUC6 q3w ×4 → A 60 mg/m²+ C 600 mg/m² q2−3w ×4

^hT 80 mg/m² qw ×12 + Cb AUC6 q3w ×4 → A 60 mg/m²+ C 600 mg/m² q2−3w ×4 +/− Pem 200 mg every 3 weeks × 8