Study study type
PathologyT1T0Patientssample sizesROB Results

es-BC - HR-positive - 1st line (L1) breast cancer - HR positive es-BC - HR-positive - 1st line (L1)

versus letrozole
taselisib plus letrozole
LORELEI, 2019
  NCT02273973		RCTes-BC - HR-positive - 1st line (L1)taselisib plus letrozoleplacebo plus letrozolePostmenopausal women (aged >= 18yr), with operable stage I-III invasive BC HR-positive (ER positive) and HER2-negative166 / 168low
 suggested
  • suggested 55 % increase in objective responses (ORR) (PE)
  • inconclusive 2.1-fold increase in pCR (PE)

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

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

versus fulvestrant
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)

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)

 

- About us - Contact us - Method - RSS Made with in Lyon - Credits - Privacy policy - Licence Creative Commons