metaEvidence - study list

									CBR DCR deaths (OS) DOR objective responses (ORR) progression or deaths (PFS) AE (grade 3-4) AE leading to death (grade 5) AE leading to treatment discontinuation (any grade) SAE (any grade) STRAE (any grade) TRAE (grade 3-4) TRAE leading to death (grade 5) TRAE leading to discontinuation (any grade) Abdominal pain TRAE (grade 3-4) Acute kidney injury TRAE (grade 3-4) Adrenal insufficiency TRAE (grade 3-4) Alopecia TRAE (grade 3-4) Anaemia TRAE (grade 3-4) Asthenia TRAE (grade 3-4) Colitis TRAE (grade 3-4) Constipation TRAE (grade 3-4) Cough TRAE (grade 3-4) Decreased appetite TRAE (grade 3-4) Diabetes TRAE (grade 3-4) Diarrhoea TRAE (grade 3-4) Dyspnoea TRAE (grade 3-4) Fatigue TRAE (grade 3-4) Febrile neutropenia TRAE (grade 3-4) Headache TRAE (grade 3-4) Hyperthyroidism TRAE (grade 3-4) Hypothyroidism TRAE (grade 3-4) Increase AST TRAE (grade 3-4) Increased ALT TRAE (grade 3-4) Leucopenia TRAE (grade 3-4) Maculopapular rash TRAE (grade 3-4) Myalgia TRAE (grade 3-4) Myositis TRAE (grade 3-4) Nausea TRAE (grade 3-4) Nephritis TRAE (grade 3-4) Neutropenia TRAE (grade 3-4) Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) Pancytopenia TRAE (grade 3-4) Peripheral sensory neuropathy TRAE (grade 3-4) Pneumonia TRAE (grade 3-4) Pneumonitis TRAE (grade 3-4) Pruritus TRAE (grade 3-4) Pyrexia TRAE (grade 3-4) Sepsis TRAE (grade 3-4) Severe skin reaction TRAE (grade 3-4) Stomatitis TRAE (grade 3-4) Thrombocytopenia TRAE (grade 3-4) Thyroiditis TRAE (grade 3-4) Urticaria TRAE (grade 3-4) Weight decreased TRAE (grade 3-4)
	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
la/mBC - TNBC - L2 - all population breast cancer - triple negative breast cancer - triple negative metastatic mBC-Triple negative (TNBC) - 2nd Line (L2) la/mBC - TNBC - L2 - all population
versus placebo plus SoC
	atezolizumab plus SoC
	IMpassion-132, ITT population, 2024 Future Oncol 2019; 15:1951-1961 Ann Oncol 2024; 35:630-642-. NCT03371017	RCT	la/mBC - TNBC - L2 - all population	atezolizumab plus SOC	placebo plus SOC	Patients with locally advanced/metastatic TNBC recurring ≤12 months after completing standard (neo)adjuvant anthracycline and taxane chemotherapy or surgery in early stage	297 / 298	low	inconclusive	no statistically significant result OS was not improved by adding atezolizumab to chemotherapy for rapidly relapsing PD-L1-positive TNBC
versus Standard of Care (SoC)
	olaparib
	OlympiAD, 2017 N Engl J Med 2017 Aug 10;377(6):523-533. Ann Oncol 2019 Apr 1;30(4):558-566. NCT02000622	RCT	la/mBC - TNBC - L2 - all population	olaparib	standard chemotherapy	Patients with HER-2 negative metastatic breast cancer that was HR positive or triple negative. Patients had a confirmed deleterious or suspected deleterious germline BRCA mutation and had receive no more than 2 previous chemotherapy regimens for metastatic disease.	205 / 97	NA	conclusif	inconclusive 10 % decrease in deaths (OS) (PE) demonstrated 42 % decrease in progression or deaths (PFS) (PE)
	pembrolizumab alone
	KEYNOTE-119 (all population), 2019 NCT02555657	RCT	la/mBC - TNBC - L2 - all population	Pembrolizumab	chemotherapy (single agent)	patients with previously treated metastatic triple negative breast cancer (mTNBC)	312 / 310	some concern	inconclusive	inconclusive 3 % decrease in deaths (OS),deaths (OS) (PE) statistically significant 60 % increase in progression or deaths (PFS),progression or deaths (PFS) statistically significant 40 % decrease in DCR,DCR