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
lapatinib plus trastuzumab
EGF104900, 2010
  NCT00320385
RCTla/mBC - HER2 positive - 2nd Line (L2)lapatinib plus trastuzumablapatinib monotherapyPatients with HER2-positive mBC who had experienced progression on prior trastuzumab-based therapy. Patients must have received prior anthracycline- and taxane-based regimens in either the adjuvant or metastatic setting.148 / 148some concern
suggested
  • suggested 26 % decrease in deaths (OS)
  • suggested 26 % decrease in progression or deaths (PFS) (PE)
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
lapatinib plus capecitabine
WJOG6110B/ELTOP, 2018
  UMIN000005219
RCTla/mBC - HER2 positive - 2nd Line (L2)lapatinib plus capecitabinetrastuzumab plus capecitabineWomen, aged 20yr or older, cith HER2-positive mBC or unresectable locally advanced BC who were previously treated with taxanes, with progression on trastuzumab-containing regimens43 / 43NA
suggested
  • inconclusive 19 % decrease in progression or deaths (PFS) (PE)
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)
versus trastuzumab plus vinorelbine
afatinib plus vinorelbine
LUX-Breast 1, 2016
  NCT01125566
RCTla/mBC - HER2 positive - 2nd Line (L2)afatinib plus vinorelbinetrastuzumab plus vinorelbineWomen with histollogically confirmed HER2 overexpressing and metastatic BC. Patient ad to have progressive disease following adjuvant treatment or first-line treatment for metastatic disease with trastuzumab.339 / 169some concern
inconclusive
  • statistically significant 48 % increase in deaths (OS)
  • inconclusive 10 % increase in progression or deaths (PFS) (PE)