Study study type
PathologyT1T0Patientssample sizesROB Results

la/mBC - HER2 positive - 2nd Line (L2) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 2nd Line (L2)

versus lapatinib plus capecitabine
neratinib plus capecitabine
NALA, 2020
  NCT01808573		RCTla/mBC - HER2 positive - 2nd Line (L2)neratinib plus capecitabinelapatinib plus capecitabinePateints with centrally confirmed HER2-positive mBC, and ≥ 2 previous HER2-directed therapies for mBC. Patients with brain metastases were eligible unless they had symptomatic or unstable brain metastases.307 / 314some concern
 conclusif
  • inconclusive 12 % decrease in deaths (OS) (PE)
  • demonstrated 24 % decrease in progression or deaths (PFS) (PE)
NALA (brain metastases), 2020
  NCT01808573		RCTla/mBC - HER2 positive - 2nd Line (L2)neratinib plus capecitabinelapatinib plus capecitabinePatients with centrally confirmed HER2-positive mBC, and ≥ 2 previous HER2-directed therapies for mBC. Patients with brain metastases were eligible unless they had symptomatic or unstable brain metastases.For this comparison, patients with brain metastases51 / 50some concern
 inconclusive
    no statistically significant result
versus placebo
neratinib
ExteNET, 2016
  NCT00878709		RCTbreast cancer - adjuvant, la/mBC - HER2 positive - 2nd Line (L2)neratinibplaceboWomen with locally confirmed invasive HER2-positive BC stage 1-3, who had received trastuzumab and chemotherapy.1420 / 1420low
 conclusif
  • demonstrated 33 % decrease in iDFS (PE)
  • suggested 37 % decrease in RFS/DFS

 

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