metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
la/mBC - HR-positive - 1st line (L1) breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 1st line (L1)
versus paclitaxel
	capivasertib plus paclitaxel
	BEECH, 2019 Ann Oncol 2019; 30:774-780-. NCT01625286	RCT	la/mBC - HR-positive - 1st line (L1)	capivasertib plus paclitaxel	placebo plus paclitaxel	patients with ER-positive advanced breast cancer with or without a PIK3CA mutation receiving chemotherapy for the first time in the advanced setting	54 / 56	low	inconclusive	inconclusive 20 % 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 Breast Cancer Res Treat 2022; 191:565-576-. NCT03337724	RCT	la/mBC - HR positive - L1 - PIK3CA mutant	ipatasertib plus paclitaxel	placebo plus paclitaxel	Patients with HR-positive and HER2-negative PIK3CA/AKT1/PTEN-altered measurable advanced breast cancer	146 / 76	low	inconclusive	inconclusive 0 % increase in progression or deaths (PFS) (PE)
mBC - Triple negative (TNBC) - 1st Line (L1) breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1)
versus Standard of Care (SoC)
	capivasertib plus paclitaxel
	PAKT (PIK3CA/AKT1/PTEN-altered), 2020 J Clin Oncol 2020; 38:423-433-. NCT02423603	RCT	mBC - Triple negative (TNBC) - 1st Line (L1)	capiversatib plus paclitaxel	placebo plus paclitaxel	Patients had histologically confirmed, metastatic or locally advanced TNBC not amenable to curative resection. Previous systemic therapy for locally advanced or metastatic disease was not permitted, but previous adjuvant or neoadjuvant chemotherapy was allowed.	17 / 11	NA	suggested	suggested 70 % decrease in progression or deaths (PFS)
mBC - TNBC - L1 - all population breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - all population
versus Standard of Care (SoC)
	capivasertib plus paclitaxel
	PAKT (all population), 2020 J Clin Oncol 2020; 38:423-433-. NCT02423603	RCT	mBC - TNBC - L1 - all population	capiversatib plus paclitaxel	placebo plus paclitaxel	Patients had histologically confirmed, metastatic or locally advanced TNBC not amenable to curative resection. Previous systemic therapy for locally advanced or metastatic disease was not permitted, but previous adjuvant or neoadjuvant chemotherapy was allowed.	70 / 70	NA	suggested	suggested 39 % decrease in deaths (OS) inconclusive 26 % decrease in progression or deaths (PFS) (PE)
	ipatasertib plus paclitaxel
	LOTUS, 2017 Lancet Oncol 2017; 18:1360-1372-. Breast Cancer Res Treat 2021; 189:377-386-. NCT02162719	RCT	mBC - TNBC - L1 - all population	ipatasertib plus paclitaxel	placebo plus paclitaxel	Women with locally advanced or metastatic TNBC not amenable to curative resection. Previous systemic therapy for locally advanced or metastatic disease was not permitted. Previous (neo)adjuvant treatment completed at least 6 months before the first dose was allowed	62 / 62	NA	suggested	suggested 40 % decrease in progression or deaths (PFS) (PE)