Study study type PathologyT1T0Patientssample sizesROB Results

la/mBC - HR-positive - 1st line (L1) breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 1st line (L1)

versus aromatase inhibitor
abemaciclib plus aromatase inhibitor
MONARCH 3, 2017
  NCT02246621
RCTla/mBC - HR-positive - 1st line (L1)abemaciclib plus a nonsteroidal aromatase inhibitorplacebo plus a nonsteroidal aromatase inhibitorPostmenopausal women (aged 18 or more)with locally advanced HR-positive, HER2-negative locoregionally recurrent BC328 / 165low
conclusif
  • demonstrated 46 % decrease in progression or deaths (PFS) (PE)
versus endocrine therapy
abemaciclib plus endocrine therapy
MonarchE, 2021
  NCT03155997
RCTla/mBC - HR-positive - 1st line (L1)abemaciclib plus endocrine therapyendocrine therapyPatients (women and men) with HR-positive and HER2-negative breast cancer. Radiotherapy and both adjuvant and neoadjuvant chemotherapy were allowed, but not required.2808 / 2829high
conclusif
  • demonstrated 25 % decrease in iDFS (PE)
palbociclib plus endocrine therapy
PENELOPE-B, 2021
  NCT01864746
RCTla/mBC - HR-positive - 1st line (L1)palbociclib plus endocrine therapy according to local standars (physician's choice)placebo plus endocrine therapy according to local standars (physician's choice)Women with residual invasive disease after NACT (NACT during at least 16 weeks) in the breats or in lymph nodes, ER and/or PR positive and HER2 negative tumor.628 / 616low
inconclusive
  • inconclusive 7 % decrease in iDFS (PE)
versus exemestane plus ridaforolimus
dalotuzumab plus ridaforolimus plus exemestane
MK-8669-064, 2017
  NCT01605396
RCTla/mBC - HR-positive - 1st line (L1)dalotuzumab plus ridaforolimus plus exemestaneridaforolimus plus exemestanePatients with metastatic or locally advanced ER-positive and HER2-negative BC40 / 40some concern
inconclusive
  • inconclusive 18 % increase in progression or deaths (PFS) (PE)
versus fulvestrant
cediranib plus fulvestrant
NCT00454805, 2013
  NCT00454805
RCTla/mBC - HR-positive - 1st line (L1)cediranib plus fulvestrantfulvestrantPostmenopausal women with histologically/cytologically confirmed hormone-sensitive BC, with evidence of metastatic disease.-/-high
inconclusive
  • inconclusive 13 % decrease in progression or deaths (PFS) (PE)
lapatinib plus fulvestrant
CALGB 40302, 2014
  NCT00390455
RCTla/mBC - HR-positive - 1st line (L1)lapatinib plus fulvestrantplacebo plus fulvestrantPostmenauposal women with stage III or IV HR-positive BC (Er and/or PR positive). Originally with HER2-positive, then an amendment to include tumors regardless of HER2 status. Patients had one or two prior endocrine treatments for at least 3 months without tumor progression in either the adjuvant or metastatic setting.-/-NA
suggested
  • inconclusive 4 % increase in progression or deaths (PFS) (PE)
versus letrozole
lapatinib plus letrozole
EGF30008 (all population), 2009
  NCT00073528
RCTla/mBC - HR-positive - 1st line (L1)lapatinib plus letrozoleplacebo plus letrozolePostmenopausal women with histologically confirmed stage IIIB/IIIC or IV, with HR positive. No prior therapy for advanced/metastatic BC was allowed, bu prior (neo)adjuvant antiestrogen therapy was allowed.642 / 644NA
conclusif
  • demonstrated 14 % decrease in progression or deaths (PFS) (PE)
EGF30008 (HER2-positive), 2009
  NCT00073528
RCTla/mBC - HR-positive - 1st line (L1)lapatinib plus letrozoleplacebo plus letrozolePostmenopausal women with histologically confirmed stage IIIB/IIIC or IV, with HR positive. No prior therapy for advanced/metastatic BC was allowed, bu prior (neo)adjuvant antiestrogen therapy was allowed.111 / 108NA
conclusif
  • demonstrated 29 % decrease in progression or deaths (PFS) (PE)
  • statistically significant 60 % decrease in CBR
  • statistically significant 60 % decrease in objective responses (ORR)
Adding lapatinib to letrozole improve significantly PFS for patients with HR-positive and HER2-positive breast cancer
palbociclib plus letrozole
PALOMA-1, 2016
  NCT00721409
RCTla/mBC - HR-positive - 1st line (L1)palbociclib plus letrozoleletrozolePostmenopausal women with ER-positive and HER2-negative advanced breast cancer. Enrolled in 2 separate cohorts (cohort 1: ER-positive and HER2-negative / cohort 2: they were also required to have cancers with amplification of cyclin D1 (CCND1), loss of p16 (also known as INK4A or CDKN2A), or both)84 / 81high
suggested
  • suggested 51 % decrease in progression or deaths (PFS) (PE)
PALOMA-2, 2016
  NCT01740427
RCTla/mBC - HR-positive - 1st line (L1)palbociclib plus letrozoleplacebo plus letrozolePostmenopausal women with ER-positive, HER2-negative advanced breast cancer were eligible for enrollment if they had not received prior systemic therapy for advanced disease.444 / 222NA
conclusif
  • demonstrated 42 % decrease in progression or deaths (PFS) (PE)
  • suggested 44 % decrease in PFS (extension)
ribociclib plus letrozole
MONALEESA-2, 2016
  NCT01958021
RCTla/mBC - HR-positive - 1st line (L1)ribociclib plus letrozoleplacebo plus letrozolePostmenauposal women with locally confirmed HR-positive, HER2-negative recurrent or metastatic BC who had not received previous systematic therapy for advanced disease334 / 334low
conclusif
  • demonstrated 24 % decrease in deaths (OS) (PE)
  • demonstrated 44 % decrease in progression or deaths (PFS) (PE)
versus paclitaxel
capivasertib plus paclitaxel
BEECH, 2019
  NCT01625286
RCTla/mBC - HR-positive - 1st line (L1)capivasertib plus paclitaxelplacebo plus paclitaxelpatients with ER-positive advanced breast cancer with or without a PIK3CA mutation receiving chemotherapy for the first time in the advanced setting54 / 56low
inconclusive
  • inconclusive 20 % 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)

la/mBC - HR positive - L1 - PIK3CA mutant breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 1st line (L1) la/mBC - HR positive - L1 - PIK3CA mutant

versus paclitaxel
ipatasertib plus paclitaxel
IPATunity130, 2022
  NCT03337724
RCTla/mBC - HR positive - L1 - PIK3CA mutantipatasertib plus paclitaxelplacebo plus paclitaxelPatients with HR-positive and HER2-negative PIK3CA/AKT1/PTEN-altered measurable advanced breast cancer146 / 76low
inconclusive
  • inconclusive 0 % increase in progression or deaths (PFS) (PE)