Neoadjuvant Chemotherapy and Targeted Therapy in Breast Cancer: Past, Present, and Future

Table 3

Trials investigating response-adapted therapy.

Trial	Phase (𝑛)	Tumors	Treatment	Primary endpoint	Other outcomes	Ref.
GeparTrio pilot	II (285)	≥2 cm	2 × TAC →; PR/CR: 4 × TAC; SD: 4 × TAC versus 4 × NX	pCR 23 versus 7 versus 3%	BCT 72%; pCR 57% <40 y with TNBC or G3)	[55]
GeparTrio	III (2012)	T2–4 N0–3; (except T2 + ER/PR pos. + cN0 + G1/2 + >35 y)	2 × TAC →; PR/CR: 4 versus 6 × TAC; SD: 4 × TAC versus 4 × NX	pCR 6 versus 8 × TAC: 21 versus 24% (𝑃=.27); pCR TAC versus NX: 5 versus 6% (𝑃=.73)	cORR 6 versus 8 × TAC: 75 versus 74% (ns); cORR TAC versus NX: both 51% (𝑃 for noninferiority = .008); BET 68 versus 59% (𝑃=.001); NX less toxic; PFS 6 versus 8 × TAC versus TAC-NX: HR 0.71 (𝑃=.001); OS 6 versus 8 × TAC versus TAC-NX: HR 0.79 (𝑃=.048); Benefit of response-guided therapy derives from HR+ tumors (no benefit for HER2+/HR− and TNBC)	[18, 56–58]
GeparQuinto (HER2 negative)	III (403)	cT3/4; cT2 if HR− or cN+; cT1 if HR− or SLN+	4 × EC ± Bev →; SD: 12 × Pac ± Rad001	pCR 4 versus 6% (𝑃=.48)	cORR 52 versus 62%; toxicity higher in the everolimus group	[19]

TAC: docetaxel, doxorubicin, cyclophosphamide; Pac: paclitaxel; NX: vinorelbine, capecitabine; EC: epirubicin, cyclophosphamide; Bev: bevacizumab; Rad001: everolimus.