Study study type PathologyT1T0Patientssample sizesROB Results

la/mBC - HR positive breast cancer - HR positive la/mBC - HR positive

versus capecitabine
palbociclib plus endocrine therapy
KCSG-BR15-10, 2019
  NCT02592746
RCTla/mBC - HR positivepalbociclib plus exemestanecapecitabinePremenopausal women aged 19 years or older with histologically confirmed, hormone receptor-positive, HER2-negative metastatic or recurrent breast cancer were eligible.92 / 86NA
suggested
  • suggested 34 % decrease in progression or deaths (PFS) (PE)
versus fulvestrant
buparlisib plus fulvestrant
BELLE-2 (patients with known PI3K status), 2017
  NCT01610284
RCTla/mBC - HR positivebuparlisib plus fulvestrantplacebo plus fulvestrantPostmenopausal women (>=18yr), with histollogically confirmed HR-positive and HER2-negative inoperable locally advanced or metastatic breast cancer (with progession on or after aromatase ihnibitor treatment). This subgroup population included ptients with a PI3K status known (activated or not)427 / 424low
conclusif
  • inconclusive 9 % decrease in deaths (OS) (PE)
  • demonstrated 20 % decrease in progression or deaths (PFS) (PE)

la/mBC - HR positive - (neo)adjuvant (NA) breast cancer - HR positive la/mBC - HR positive la/mBC - HR positive - (neo)adjuvant (NA)

versus letrozole
alpelisib plus letrozole
NEO-ORB (wild type cohort), 2019
  NCT01923168
RCTla/mBC - HR positive - (neo)adjuvant (NA)alpelisib plus letrozoleletrozolePostmenopausal women with locally confirmed, HR , HER2−, T1c-T3 operable breast cancer with known PIK3CA mutation status, who had not previously received treatment with local or systemic therapy and were considered eligible for neoadjuvant endocrine therapy were included in this study.131 / 126NA
inconclusive
  • inconclusive 11 % increase in objective responses (ORR) (PE)
  • inconclusive 68 % increase in pCR (PE)
NEO-ORB (mutant cohort), 2019
  NCT01923168
RCTla/mBC - HR positive - (neo)adjuvant (NA)alpelisib plus letrozoleletrozolePostmenopausal women with locally confirmed, HR , HER2−, T1c-T3 operable breast cancer with known PIK3CA mutation status, who had not previously received treatment with local or systemic therapy and were considered eligible for neoadjuvant endocrine therapy were included in this study.-/-NA
inconclusive
  • inconclusive 6 % decrease in objective responses (ORR) (PE)
  • inconclusive 45 % decrease in pCR (PE)

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)

la/mBC - HR-positive - 2nd line (L2) breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 2nd line (L2)

versus chemotherapy
OBI-822/OBI-821 plus cyclophosphamide
Huang, 2020
  NCT01516307
RCTla/mBC - HR-positive - 2nd line (L2)OBI-822/OBI-821 plus cyclophsophamidecyclophsophamideWomen with MBC achieving SD, partial response (PR), or complete response (CR) after at least one anticancer therapy and with no more than two events of progressive disease after MBC diagnosis. Patients with HR positive were allowed to continue antihormonal therapy with study treatment225 / 124NA
inconclusive
  • inconclusive 4 % decrease in progression or deaths (PFS) (PE)
versus endocrine therapy
ganitumab plus endocrine therapy
QUILT-2.015, 2013
  NCT00626106
RCTla/mBC - HR-positive - 2nd line (L2)ganitumumab plus exemestane or fulvetrantplacebo plus exemestane or fulvestrantpostmenopausal women with histologically confirmed HR positive breast cancer and locally advanced or metastatic disease that could not be cured by surgery or radiation. patients from outpatient clinics and hospitals. All patients had HR-positive disease-/-low
inconclusive
  • statistically significant 78 % increase in deaths (OS)
  • inconclusive 17 % increase in progression or deaths (PFS) (PE)
ribociclib plus endocrine therapy
MONALEESA-7, 2018
  NCT02278120
RCTla/mBC - HR-positive - 2nd line (L2)ribociclib plus endocrine therapy plus goserelinplacebo plus endocrine therapy plus goserelinWomen premenopausal or perimenopausal at the time of entry, with histologically or cytologically confirmed HR-positive and HER2-negative breast cancer.335 / 337low
conclusif
  • demonstrated 45 % decrease in progression or deaths (PFS) (PE)
versus exemestane
entinostat plus exemestane
E2112, 2021
  NCT02115282
RCTla/mBC - HR-positive - 2nd line (L2)entinostat plus exemestaneplacebo plus exemestaneWomen and men who had histologically confirmed invasive adenocarcinoma of the breast, metastatic or locally advanced and not amenable to local therapy with curative intent305 / 303low
inconclusive
  • inconclusive 1 % decrease in deaths (OS) (PE)
  • inconclusive 13 % decrease in progression or deaths (PFS) (PE)
ENCORE301, 2013
  NCT00676663
RCTla/mBC - HR-positive - 2nd line (L2)entinostat plus exemestaneplacebo plus exemestanePostmenopausal women with ER-positive BC who were experiencing disease relapse or progression while receiving an NSAI64 / 66NA
suggested
  • suggested 41 % decrease in deaths (OS)
  • inconclusive 27 % decrease in progression or deaths (PFS) (PE)
tucidinostat plus exemestane
ACE, 2019
  NCT02482753
RCTla/mBC - HR-positive - 2nd line (L2)tucidinostat plus exemestaneplacebo plus exemestanePostmenopausal women with HR-positive, HER2-negative, inoperable BC, whose disese relapsed after at least one endocrine therapy.244 / 121low
conclusif
  • demonstrated 25 % decrease in progression or deaths (PFS) (PE)
versus fulvestrant
abemaciclib plus fulvestrant
MONARCH 2, 2020
  NCT02107703
RCTla/mBC - HR-positive - 2nd line (L2)abemaciclib plus fulvestrantplacebo plus fulvestrantWomen with HR-positive and HER2-negative advanced breast (ABC) cancer who progressed during neoadjuvant or adjuvantendocrine therapy (ET), within 12months after adjuvant ET, or while receiving first line ET for ABC446 / 223low
conclusif
  • demonstrated 24 % decrease in deaths (OS) (PE)
  • demonstrated 45 % decrease in progression or deaths (PFS) (PE)
alpelisib plus fulvestrant
SOLAR-1 (patients with PIK3CA mutant status), 2019
  NCT02437318
RCTla/mBC - HR-positive - 2nd line (L2)alpelisib plus fulvestrantplacebo plus fulvestrantPatients were men and postmenauposal women with locally advanced confirmed HR positive, HER2 negative breast cancer169 / 172low
conclusif
  • inconclusive 14 % decrease in deaths (OS) (PE)
  • demonstrated 35 % decrease in progression or deaths (PFS) (PE)
SOLAR-1 (patients without PIK3CA mutant status), 2019
  NCT02437318
RCTla/mBC - HR-positive - 2nd line (L2)alpelisib plus fulvestrantplacebo plus fulvestrantPatients were men and postmenauposal women with locally advanced confirmed HR positive, HER2 negative breast cancer / Patient has recurrence or progression of disease during or after AI therapy115 / 116low
inconclusive
  • inconclusive 15 % decrease in progression or deaths (PFS) (PE)
buparlisib plus fulvestrant
BELLE-3, 2018
  NCT01633060
RCTla/mBC - HR-positive - 2nd line (L2)buparlisib plus fulvestrantplacebo plus fulvestrantPostmenopausal women (aged >= 18yr) with HR-positive, HER2-negative, locally advanced or metastatic breast cancer pretreated with aromatase inhibitors and resistant to endocrine therapy for advanced BC.289 / 143NA
conclusif
  • demonstrated 33 % decrease in progression or deaths (PFS) (PE)
dalpiciclib plus fulvestrant
DAWNA-1, 2021
  NCT03927456
RCTla/mBC - HR-positive - 2nd line (L2)dalpiciclib plus fulvetrantplacebo (matching dulpaciclib) plus fulvestrantWomen aged of 18-75yr with pathologically confirmed HR-positive and HER2-negative locally advanced or metastatic BC. Nor more than 1 previous chemotherapy for advanced disease.241 / 120low
conclusif
  • demonstrated 58 % decrease in progression or deaths (PFS) (PE)
palbociclib plus fulvestrant
FLIPPER, 2021
  NCT02690480
RCTla/mBC - HR-positive - 2nd line (L2)palbociclib plus fulvestrantplacebo plus fulvestrantPostmenauposal women with HR-positive and HER-negative advanced breast cancer94 / 95low
suggested
  • suggested 45 % decrease in progression or deaths (PFS) (PE)
PALOMA-3, 2016
  NCT01942135
RCTla/mBC - HR-positive - 2nd line (L2)palbociclib plus fulvestrantplacebo plus fulvestrantEligible patients were pre- or post menopausal with breast cancer and histologic or cytologicconfirmation of recurrent local or distant disease progression during or within 12 months of completion of adjuvant endocrinetherapy or while receiving or within 1 month after receivingendocrine therapy for MBC347 / 174low
conclusif
  • inconclusive 19 % decrease in deaths (OS) (PE)
  • demonstrated 58 % decrease in progression or deaths (PFS) (PE)
ribociclib plus fulvestrant
MONALEESA-3, 2018
  NCT02422615
RCTla/mBC - HR-positive - 2nd line (L2)ribociclib plus fulvestrantplacebo plus fulvestrantPostmenopausal women and men with confirmed HR-positive and HER2-negative advanced/metastatic breast cancer484 / 242low
conclusif
  • demonstrated 28 % decrease in deaths (OS) (PE)
  • demonstrated 41 % decrease in progression or deaths (PFS) (PE)
  • suggested 27 % decrease in deaths (OS) (extension)
sapanisertib plus fulvestrant
NCT02756364 (sapanisertib daily), 2022
  NCT02756364
RCTla/mBC - HR-positive - 2nd line (L2)sapanasertib plus fulvestrantfulvestrantPostmenopausal women with histologic confirmation of ER-positive and HER2-negative metastatic or advanced BC47 / 46some concern
inconclusive
  • inconclusive 23 % decrease in progression or deaths (PFS) (PE)
NCT02756364 (sapanisertib weekly), 2022
  NCT02756364
RCTla/mBC - HR-positive - 2nd line (L2)sapinasertib plus fulvestrantfulvestrantPostmenopausal women with histologic confirmation of ER-positive and HER2-negative metastatic or advanced BC48 / 46NA
inconclusive
    no statistically significant result
versus paclitaxel
alisertib plus paclitaxel
NCT02187991 - HR-positive and HER2-negative cohort, 2021
  NCT02187991
RCTla/mBC - HR-positive - 2nd line (L2)alisertib plus paclitaxelpaclitaxelPostemenopausal women (aged >= 18yr) with metastatic or unresectable locally recurrent BC confirmed as ER-positive (HR-positive), ERBB2-negative (HER2-negative) invasive BCor grade 3 TNBC69 / 70high
suggested
  • suggested 44 % decrease in progression or deaths (PFS) (PE)
versus placebo
metformin
Pimentel, 2019
  NCT01310231
RCTla/mBC - HR-positive - 2nd line (L2)metformin plus chemotherapyplacebo plus chemotherapyWomen with metastatic or unresectable locally advanced BC, about to receive 1st to 4th line, any HR or HER2 status22 / 18NA
inconclusive
  • inconclusive 20 % increase in progression or deaths (PFS) (PE)
These results do not support the use of metformin with chemotherapy in non-diabetic MBC patients.

la/mBC - HR positive - L2 - all population breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 2nd line (L2) la/mBC - HR positive - L2 - all population

versus fulvestrant
buparlisib plus fulvestrant
BELLE-2 (full population), 2017
  NCT01610284
RCTla/mBC - HR positive - L2 - all populationbuparlisib plus fulvestrantplacebo plus fulvestrantPostmenopausal women (>=18yr), with histollogically confirmed HR-positive and HER2-negative inoperable locally advanced or metastatic breast cancer (with progession on or after aromatase ihnibitor treatment)576 / 571low
conclusif
  • inconclusive 13 % decrease in deaths (OS) (PE)
  • demonstrated 22 % decrease in progression or deaths (PFS) (PE)

la/mBC - HR positive - L2 - PIK3CA mutant breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 2nd line (L2) la/mBC - HR positive - L2 - PIK3CA mutant

versus fulvestrant
buparlisib plus fulvestrant
BELLE-2 (PI3K pathway activated), 2017
  NCT01610284
RCTla/mBC - HR positive - L2 - PIK3CA mutantbuparlisib plus fulvestrantplacebo plus fulvestrantPostmenopausal women (>=18yr), with histollogically confirmed HR-positive and HER2-negative inoperable locally advanced or metastatic breast cancer (with progession on or after aromatase ihnibitor treatment). This subgroup population included only patients with PI3K pathway activated188 / 184low
suggested
  • suggested 24 % decrease in progression or deaths (PFS) (PE)