metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
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 J Immunother Cancer 2020; 8:67-77-. NCT01516307	RCT	la/mBC - HR-positive - 2nd line (L2)	OBI-822/OBI-821 plus cyclophsophamide	cyclophsophamide	Women 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 treatment	225 / 124	NA	inconclusive	inconclusive 4 % decrease in progression or deaths (PFS) (PE)
versus endocrine therapy
	ganitumab plus endocrine therapy
	QUILT-2.015, 2013 Lancet Oncol 2013; 14:228-35-. NCT00626106	RCT	la/mBC - HR-positive - 2nd line (L2)	ganitumumab plus exemestane or fulvetrant	placebo plus exemestane or fulvestrant	postmenopausal 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 Lancet Oncol 2018; 19:904-915-. Clin Cancer Res 2022; 28:851-859-. N Engl J Med 2019; 381:307-316-. NCT02278120	RCT	la/mBC - HR-positive - 2nd line (L2)	ribociclib plus endocrine therapy plus goserelin	placebo plus endocrine therapy plus goserelin	Women premenopausal or perimenopausal at the time of entry, with histologically or cytologically confirmed HR-positive and HER2-negative breast cancer.	335 / 337	low	conclusif	demonstrated 45 % decrease in progression or deaths (PFS) (PE)
versus exemestane
	entinostat plus exemestane
	E2112, 2021 J Clin Oncol 2021; 39:3171-3181-. NCT02115282	RCT	la/mBC - HR-positive - 2nd line (L2)	entinostat plus exemestane	placebo plus exemestane	Women and men who had histologically confirmed invasive adenocarcinoma of the breast, metastatic or locally advanced and not amenable to local therapy with curative intent	305 / 303	low	inconclusive	inconclusive 1 % decrease in deaths (OS) (PE) inconclusive 13 % decrease in progression or deaths (PFS) (PE)
	ENCORE301, 2013 J Clin Oncol 2013; 31:2128-35-. NCT00676663	RCT	la/mBC - HR-positive - 2nd line (L2)	entinostat plus exemestane	placebo plus exemestane	Postmenopausal women with ER-positive BC who were experiencing disease relapse or progression while receiving an NSAI	64 / 66	NA	suggested	suggested 41 % decrease in deaths (OS) inconclusive 27 % decrease in progression or deaths (PFS) (PE)
	tucidinostat plus exemestane
	ACE, 2019 Lancet Oncol 2019; 20:806-815-. NCT02482753	RCT	la/mBC - HR-positive - 2nd line (L2)	tucidinostat plus exemestane	placebo plus exemestane	Postmenopausal women with HR-positive, HER2-negative, inoperable BC, whose disese relapsed after at least one endocrine therapy.	244 / 121	low	conclusif	demonstrated 25 % decrease in progression or deaths (PFS) (PE)
versus fulvestrant
	abemaciclib plus fulvestrant
	MONARCH 2, 2020 JAMA Oncol 2020; 6:116-124-. Breast Cancer Res 2021; 23:87-. J Clin Oncol 2017 Sep 1;35(25):2875-2884. Oncologist 2020; 25:e243-e251-. NCT02107703	RCT	la/mBC - HR-positive - 2nd line (L2)	abemaciclib plus fulvestrant	placebo plus fulvestrant	Women 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 ABC	446 / 223	low	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 N. Engl. J. Med. 2019; 380:1929-1940 Ann Oncol 2021; 32:208-217-. NCT02437318	RCT	la/mBC - HR-positive - 2nd line (L2)	alpelisib plus fulvestrant	placebo plus fulvestrant	Patients were men and postmenauposal women with locally advanced confirmed HR positive, HER2 negative breast cancer	169 / 172	low	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 N. Engl. J. Med. 2019; 380:1929-1940 Ann Oncol 2021; 32:208-217-. NCT02437318	RCT	la/mBC - HR-positive - 2nd line (L2)	alpelisib plus fulvestrant	placebo plus fulvestrant	Patients 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 therapy	115 / 116	low	inconclusive	inconclusive 15 % decrease in progression or deaths (PFS) (PE)
	buparlisib plus fulvestrant
	BELLE-3, 2018 Lancet Oncol 2018; 19:87-100-. NCT01633060	RCT	la/mBC - HR-positive - 2nd line (L2)	buparlisib plus fulvestrant	placebo plus fulvestrant	Postmenopausal 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 / 143	NA	conclusif	demonstrated 33 % decrease in progression or deaths (PFS) (PE)
	dalpiciclib plus fulvestrant
	DAWNA-1, 2021 Nat Med 2021; 27:1904-1909-. NCT03927456	RCT	la/mBC - HR-positive - 2nd line (L2)	dalpiciclib plus fulvetrant	placebo (matching dulpaciclib) plus fulvestrant	Women 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 / 120	low	conclusif	demonstrated 58 % decrease in progression or deaths (PFS) (PE)
	palbociclib plus fulvestrant
	FLIPPER, 2021 Eur J Cancer 2022; 161:26-37-. NCT02690480	RCT	la/mBC - HR-positive - 2nd line (L2)	palbociclib plus fulvestrant	placebo plus fulvestrant	Postmenauposal women with HR-positive and HER-negative advanced breast cancer	94 / 95	low	suggested	suggested 45 % decrease in progression or deaths (PFS) (PE)
	PALOMA-3, 2016 Oncologist 2021; 26 Suppl 3:S5-S6-. Oncologist 2016; 21:1165-1175-. Lancet Oncol 2016; 17:425-439-. N Engl J Med 2015; 373:209-19-. Oncologist 2017; 22:1028-1038-. N Engl J Med 2018; 379:1926-1936-. Int J Clin Oncol 2019; 24:262-273-. NCT01942135	RCT	la/mBC - HR-positive - 2nd line (L2)	palbociclib plus fulvestrant	placebo plus fulvestrant	Eligible 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 MBC	347 / 174	low	conclusif	inconclusive 19 % decrease in deaths (OS) (PE) demonstrated 58 % decrease in progression or deaths (PFS) (PE)
	ribociclib plus fulvestrant
	MONALEESA-3, 2018 J Clin Oncol 2018 Aug 20;36(24):2465-2472. N Engl J Med 2020 Feb 6;382(6):514-524. Ann Oncol 2021 Aug;32(8):1015-1024. NCT02422615	RCT	la/mBC - HR-positive - 2nd line (L2)	ribociclib plus fulvestrant	placebo plus fulvestrant	Postmenopausal women and men with confirmed HR-positive and HER2-negative advanced/metastatic breast cancer	484 / 242	low	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 Clin Cancer Res 2022; 28:1107-1116-. NCT02756364	RCT	la/mBC - HR-positive - 2nd line (L2)	sapanasertib plus fulvestrant	fulvestrant	Postmenopausal women with histologic confirmation of ER-positive and HER2-negative metastatic or advanced BC	47 / 46	some concern	inconclusive	inconclusive 23 % decrease in progression or deaths (PFS) (PE)
	NCT02756364 (sapanisertib weekly), 2022 Clin Cancer Res 2022; 28:1107-1116-. NCT02756364	RCT	la/mBC - HR-positive - 2nd line (L2)	sapinasertib plus fulvestrant	fulvestrant	Postmenopausal women with histologic confirmation of ER-positive and HER2-negative metastatic or advanced BC	48 / 46	NA	inconclusive	no statistically significant result
versus paclitaxel
	alisertib plus paclitaxel
	NCT02187991 - HR-positive and HER2-negative cohort, 2021 JAMA Netw Open 2021; 4:e214103-. NCT02187991	RCT	la/mBC - HR-positive - 2nd line (L2)	alisertib plus paclitaxel	paclitaxel	Postemenopausal women (aged >= 18yr) with metastatic or unresectable locally recurrent BC confirmed as ER-positive (HR-positive), ERBB2-negative (HER2-negative) invasive BCor grade 3 TNBC	69 / 70	high	suggested	suggested 44 % decrease in progression or deaths (PFS) (PE)
versus placebo
	metformin
	Pimentel, 2019 Breast 2019; 48:17-23-. NCT01310231	RCT	la/mBC - HR-positive - 2nd line (L2)	metformin plus chemotherapy	placebo plus chemotherapy	Women with metastatic or unresectable locally advanced BC, about to receive 1st to 4th line, any HR or HER2 status	22 / 18	NA	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 Lancet Oncol 2017; 18:904-916-. Eur J Cancer 2018; 103:147-154-. NCT01610284	RCT	la/mBC - HR positive - L2 - all population	buparlisib plus fulvestrant	placebo plus fulvestrant	Postmenopausal 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 / 571	low	conclusif	inconclusive 13 % decrease in deaths (OS) (PE) demonstrated 22 % decrease in progression or deaths (PFS) (PE)
versus pegylated liposomal doxorubicin and cyclophosphamide
	nivolumab plus ipilimumab, pegylated liposomal doxorubicin and cyclophosphamide
	ICON, 2024 J Immunother Cancer 2024; 12:1240-1247-. J Transl Med 2020; 18:269-. NCT03409198	RCT	la/mBC - HR positive - L2 - all population	Ipilimumab plus nivolumab plus PLD plus cyclophosphamide	PLD plus cyclophosphamide	Patients with HR mBC starting first-/second- line chemotherapy (chemo)	49 / 33	some concern	inconclusive	inconclusive 6 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE) The addition of ipi/nivo to chemotherapy increased toxicity without improving efficacy. Ipi/nivo administered sequentially to chemotherapy was tolerable and induced clinical responses.
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 Lancet Oncol 2017; 18:904-916-. NCT01610284	RCT	la/mBC - HR positive - L2 - PIK3CA mutant	buparlisib plus fulvestrant	placebo plus fulvestrant	Postmenopausal 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 activated	188 / 184	low	suggested	suggested 24 % decrease 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)

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

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