Tyrosine kinase inhibitors and human epidermal growth factor receptor-2 positive breast cancer

Table 1 Main ongoing and completed phase 3 trials evaluating tyrosine kinase inhibitors with HER2+ breast cancer

Study title	Conditions	Interventions	Outcome measures	NCT number
Pyrotinib rechallenge in HER2-positive metastatic breast cancer pretreated with Pyrotinib and Trastuzumab	HER2-positive breast cancer, metastatic breast cancer	Trastuzumab plus chemotherapy: Trastuzumab in combination with Pyrotinib plus chemotherapy	PFS, ORR, AEs	NCT05346861[14]
A study of Pyrotinib plus Capecitabine in patients with HER2+ metastatic breast cancer	HER2 positive metastatic breast cancer	Pyrotinib, Capecitabine	PFS, ORR, AEs, SAEs, DoR, CBR, OS	NCT02973737[15]
A randomized controlled trial of HER2 positive breast cancer patients treated with Lapatinib vs herceptin	HER2-positive breast cancer	Lapatinib/Herceptin	DFS, OS	NCT03085368[16]
Tykerb evaluation after chemotherapy (TEACH): Lapatinib versus placebo in women with early-stage breast cancer	Neoplasms, breast	Lapatinib	This clinical trial has several outcomes measures to be evaluated including DFS, OS, MDFS	NCT00374322[17]
Neo altto (neoadjuvant Lapatinib and/or Trastuzumab treatment optimization) study	Neoplasms, breast	Lapatinib, Trastuzumab, Paclitaxel	This clinical trial has several outcomes measures to be evaluated including OS, Par with pCR at the ToS, OR at the ToS	NCT00553358[18]
Lapatinib in combination with Trastuzumab versus Lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer	Neoplasms, breast	Lapatinib, Trastuzumab	PFS, OS, OR, CBR, TTR, DR, change from baseline in FACT-B scores at week 4, week 12, week 16, week 24, and conclusion or withdrawal from study	NCT00320385[19]
Paclitaxel with/without GW572016 (Lapatinib) as first line therapy for women with advanced or metastatic breast cancer	Neoplasms, breast	Paclitaxel, GW572016 (Lapatinib)	This clinical trial has several outcomes measures to be evaluated including PFS, OS, DoR	NCT00075270[20]
Continued HER2 suppression with Lapatinib plus Trastuzumab vs Trastuzumab alone (terminated)	Cancer	Lapatinib, Trastuzumab	PFS, OS, Best overall response, CBR (CR, PR or SD ≥ 24 wk), AE	NCT00968968[21]

PFS: Progression-free survival; ORR: overall response rate; AEs: Adverse events; SAE; serious adverse events; DoR: Duration of response; OS: Overall survival; CBR: Clinical benefit rate; MDFS; Modified disease-free survival; Par: Number of participants; TTR: Time in the therapeutic range; DR: Duration of response; pCR: Pathological complete response; DFS: Disease-free Survival; FACT-B: Functional assessment of cancer therapy-breast cancer; OR: Overall response; ToS: Time of surgery; NCT: National clinical trial.