Copyright ©The Author(s) 2023.
World J Clin Oncol. May 24, 2023; 14(5): 198-202
Published online May 24, 2023. doi: 10.5306/wjco.v14.i5.198
Table 1 Main ongoing and completed phase 3 trials evaluating tyrosine kinase inhibitors with HER2+ breast cancer
Study title
Outcome measures
NCT number
Pyrotinib rechallenge in HER2-positive metastatic breast cancer pretreated with Pyrotinib and TrastuzumabHER2-positive breast cancer, metastatic breast cancerTrastuzumab plus chemotherapy: Trastuzumab in combination with Pyrotinib plus chemotherapyPFS, ORR, AEsNCT05346861[14]
A study of Pyrotinib plus Capecitabine in patients with HER2+ metastatic breast cancerHER2 positive metastatic breast cancerPyrotinib, CapecitabinePFS, ORR, AEs, SAEs, DoR, CBR, OSNCT02973737[15]
A randomized controlled trial of HER2 positive breast cancer patients treated with Lapatinib vs herceptinHER2-positive breast cancerLapatinib/HerceptinDFS, OSNCT03085368[16]
Tykerb evaluation after chemotherapy (TEACH): Lapatinib versus placebo in women with early-stage breast cancerNeoplasms, breastLapatinibThis clinical trial has several outcomes measures to be evaluated including DFS, OS, MDFSNCT00374322[17]
Neo altto (neoadjuvant Lapatinib and/or Trastuzumab treatment optimization) studyNeoplasms, breastLapatinib, Trastuzumab, PaclitaxelThis clinical trial has several outcomes measures to be evaluated including OS, Par with pCR at the ToS, OR at the ToSNCT00553358[18]
Lapatinib in combination with Trastuzumab versus Lapatinib monotherapy in subjects with HER2-positive metastatic breast cancerNeoplasms, breastLapatinib, TrastuzumabPFS, 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 studyNCT00320385[19]
Paclitaxel with/without GW572016 (Lapatinib) as first line therapy for women with advanced or metastatic breast cancerNeoplasms, breastPaclitaxel, GW572016 (Lapatinib)This clinical trial has several outcomes measures to be evaluated including PFS, OS, DoRNCT00075270[20]
Continued HER2 suppression with Lapatinib plus Trastuzumab vs Trastuzumab alone (terminated)CancerLapatinib, TrastuzumabPFS, OS, Best overall response, CBR (CR, PR or SD ≥ 24 wk), AENCT00968968[21]