Study study type
PathologyT1T0Patientssample sizesROB Results

es-BC - HER2 positive - (neo)adjuvant (NA) breast cancer - HER2-positive es-BC - HER2 positive - (neo)adjuvant (NA)

versus lapatinib plus epirubicin and cyclophosphamide followed by docetaxel
trastuzumab plus epirubicin and cyclophosphamide followed by docetaxel
GeparQuinto, 2012
  NCT00567554		RCTes-BC - HER2 positive - (neo)adjuvant (NA)trastuzumab plus epirubicin and cyclophosphamide followed by docetaxellapatinib plus epirubicin and cyclophosphamide followed by docetaxelWomen with previouscly untreated unilateral or bilateral primary invasive breast carcinoma, with HER2-positive309 / 311NA
 conclusif
  • demonstrated 48 % increase in pCR (PE)

la/mBC - HER2 positive - 1st Line (L1) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 1st Line (L1)

versus trastuzumab
pertuzumab plus trastuzumab
PERTAIN, 2018
  NCT01491737		RCTla/mBC - HER2 positive - 1st Line (L1)pertuzumab plus trastuzumab plus an AI (letrozole or anastrozole)trastuzumab plus an AI (letrozole or anastrozole)Postmenopausal patients, with first-line HER2-positive and HR positive disease129 / 129NA
 conclusif
  • demonstrated 35 % decrease in progression or deaths (PFS) (PE)
versus trastuzumab plus chemotherapy
trastuzumab plus endocrine therapy
SYSUCC-002, 2022
  NCT01950182		RCTla/mBC - HER2 positive - 1st Line (L1), la/mBC - HR-positive - 1st line (L1)trastuzumab plus endocrine therapytrastuzumab plus chemotherapyFemale patients aged of 18 or more, with locally histology confirmed mBC, HR-positive (ER and/or PR-positive) and HER2-positive196 / 196some concern
 inconclusive
  • inconclusive 12 % decrease in progression or deaths (PFS) (PE)
versus trastuzumab plus docetaxel
pertuzumab plus trastuzumab plus docetaxel
PUFFIN, 2020
  NCT02896855		RCTla/mBC - HER2 positive - 1st Line (L1)pertuzumab plus trastuzumab plus docetaxelplacebo plus trastuzumab plus docetaxelPatients with HER2-positive, locally recurrent or metastatic BC, no prior therapy for metastatic disease, 18yr or older.-/-NA
 suggested
  • suggested 31 % decrease in progression or deaths (PFS)
CLEOPATRA, 2012
  NCT00567190		RCTla/mBC - HER2 positive - 1st Line (L1)pertuzumab plus trastuzumab plus docetaxelplacebo plus trastuzumab plus docetaxelPatients with locally recurrent, unresectable, or metastatic HER2-positive breast cancer who had not received chemotherapy or biologic therapy for their metastatic disease. They may have received one hormonal treatment for metastatic breast cancer before randomization, and/or adjuvant or neoadjuvant chemotherapy with or without trastuzumab before randomization402 / 406low
 conclusif
  • demonstrated 34 % decrease in deaths (OS) (PE)
  • demonstrated 38 % decrease in progression or deaths (PFS) (PE)
  • suggested 31 % decrease in deaths (OS) (extension)
  • suggested 31 % decrease in PFS (extension)
    • more...

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
versus trastuzumab plus capecitabine
tucatinib plus trastuzumab plus capecitabine
HER2CLIMB (patients with brain metastases), 2020
  NCT02614794		RCTla/mBC - HER2 positive - 2nd Line (L2)tucatinib plus trastuzumab plus capecitabineplacebo plus trastuzumab plus capecitabinePatients with HER2-positive advanced breast cancer, had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients with brain metastases were included unless they were in need of immediate local intervention (enrolled subsequently), or with untreated brain metastases larger than 2 cm in diameter could be enrolled with approval from the medical monitor.198 / 93low
 conclusif
  • demonstrated 52 % decrease in progression or deaths (PFS) (PE)
HER2CLIMB, 2020
  NCT02614794		RCTla/mBC - HER2 positive - 2nd Line (L2)tucatinib plus trastuzumab plus capecitabineplacebo plus trastuzumab plus capecitabinePatients with HER2-positive advanced breast cancer, had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients with brain metastases were included unless they were in need of immediate local intervention (enrolled subsequently), or with untreated brain metastases larger than 2 cm in diameter could be enrolled with approval from the medical monitor.410 / 202low
 conclusif
  • demonstrated 34 % decrease in deaths (OS) (PE)
  • demonstrated 46 % decrease in progression or deaths (PFS) (PE)

 

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