| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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es-BC - TNBC - NA - all population breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus carboplatin plus nab-paclitaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus carboplatin plus nab-paclitaxel vs. carboplatin plus nab-paclitaxel | 1 | none | inconclusive results for: pCR | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab alone vs. placebo | 1 | none | inconclusive results for: deaths (OS) (extension); pCR ; AE leading to death (grade 5); SAE (any grade); hepatitis (Autoimmune) AE (grade 3-4); Abdominal pain AE (grade 3-4); Alopecia AE (grade 3-4); Anaemia AE (grade 3-4); Arthralgia AE (grade 3-4); Back pain AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Diarrhoea AE (grade 3-4); Dry skin AE (grade 3-4); Dyspnoea AE (grade 3-4); Epistaxis AE (grade 3-4); Fatigue AE (grade 3-4); Febrile neutropenia AE (grade 3-4); Headache AE (grade 3-4); Hyperthyroidism AE (grade 3-4); Hypophysitis AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Infusion-related reaction AE (grade 3-4); Injury, poisoning and procedure AE (grade 3-4); Leucopenia AE (grade 3-4); Myalgia AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Peripheral neuropathy AE (grade 3-4); Pneumonitis AE (grade 3-4); Rash AE (grade 3-4); Stomatitis AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Vomiting AE (grade 3-4) | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. placebo | 1 | none | inconclusive results for: AE (any grade); AE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); 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); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Sarcoidosis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 37 % decrease in events or deaths (EFS) but the degree if certainty is unassessable statistically conclusive 13.6-fold increase in pCR but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus nab-paclitxel followed by doxorubicin plus cyclophosphamide vs. placebo plus SoC | 1 | none | inconclusive results for: deaths (OS); events or deaths (EFS); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Guillain-Barré syndrome TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Myositis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Rash TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Alopecia AE (grade 3-4); Anaemia AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dry skin AE (grade 3-4); Dysgeusia AE (grade 3-4); Dyspepsia AE (grade 3-4); Dyspnoea AE (grade 3-4); Epistaxis AE (grade 3-4); Fatigue AE (grade 3-4); Febrile neutropenia AE (grade 3-4); Headache AE (grade 3-4); Hypertension AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Infusion-related reaction AE (grade 3-4); Lacrimation increased AE (grade 3-4); Leucopenia AE (grade 3-4); Mucosal inflammation AE (grade 3-4); Myalgia AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Oropharyngeal pain AE (grade 3-4); Paraesthesia AE (grade 3-4); Peripheral neuropathy AE (grade 3-4); Peripheral oedema AE (grade 3-4); Peripheral sensory neuropathy AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Stomatitis AE (grade 3-4); Vomiting AE (grade 3-4) | statistically conclusive 95 % increase in pCR but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
es-BC - TNBC - NA - PDL1 positive breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus nab-paclitxel followed by doxorubicin plus cyclophosphamide vs. placebo plus SoC | 1 | none | - | suggested 2.2-fold increase in pCR but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC - Triple negative (TNBC) - 1st Line (L1) breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC - TNBC - L1 - all population breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: deaths (OS); objective responses (ORR); AE (any grade); AE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4) | suggested 18 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus nab-paclitaxel vs. Standard of Care (SoC) | 1 | inconclusive results for: deaths (OS); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); hepatitis (Autoimmune) AE (grade 3-4); Abdominal pain AE (grade 3-4); Acute kidney injury AE (grade 3-4); Adrenal insufficiency AE (grade 3-4); Alopecia AE (grade 3-4); Anaemia AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Cardiomyopathy AE (grade 3-4); Chills AE (grade 3-4); Colitis AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dizziness AE (grade 3-4); Dysgeusia AE (grade 3-4); Dysphonia AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Hypertension AE (grade 3-4); Hyperthyroidism AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Leucopenia AE (grade 3-4); Mucosal inflammation AE (grade 3-4); Myalgia AE (grade 3-4); Myopathy AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Paraesthesia AE (grade 3-4); Pericarditis AE (grade 3-4); Peripheral neuropathy AE (grade 3-4); Pneumonia AE (grade 3-4); Pneumonitis AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Sepsis AE (grade 3-4); Stomatitis AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | suggested 20 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 22 % decrease in DOR but the degree if certainty is unassessable suggested 52 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus paclitaxel vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC - TNBC - L1 - PDL1 positive breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus SoC vs. placebo plus SoC | 2 | statistically conclusive 18 % decrease in deaths (OS) statistically conclusive 28 % decrease in progression or deaths (PFS) | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus nab-paclitaxel vs. Standard of Care (SoC) | 1 | none | - | suggested 29 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 37 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 40 % decrease in DOR but the degree if certainty is unassessable suggested 96 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus paclitaxel vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC-Triple negative (TNBC) - 2nd Line (L2) breast cancer - triple negative mBC-Triple negative (TNBC) - 2nd Line (L2) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC - TNBC - L2 - all population breast cancer - triple negative mBC-Triple negative (TNBC) - 2nd Line (L2) mBC - TNBC - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); SAE (any grade); 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); 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); 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) | suggested 71 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mBC - TNBC - L2 - PDL1 positive breast cancer - triple negative mBC-Triple negative (TNBC) - 2nd Line (L2) mBC - TNBC - L2 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. Standard of Care (SoC) | 2 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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