Abstract
Background:
Sequential neoadjuvant chemotherapy (NAC) regimens of taxanes with carboplatin followed by anthracyclines with cyclophosphamide (AC/EC) result in pathological complete responses (pCR) in 55-60% of patients with Stage II/III triple-negative breast cancer (TNBC) who enjoy a favorable prognosis. However, those with residual invasive disease (RID) following NAC have an increased risk of recurrence even with adjuvant capecitabine. Immune checkpoint inhibitors have demonstrated improved outcomes in patients with PD-L1-positive metastatic breast cancer and increased pCR when added to NAC for Stage II/III TNBC, irrespective of PD-L1 status. This trial evaluated the efficacy and safety of adding atezolizumab to NAC followed by atezolizumab as adjuvant therapy to complete 1 year of therapy in Stage II/III TNBC. The required number of events was confirmed on 09/16/2024 to establish the data cut-off for conduct of the planned definitive analysis of the primary endpoint, event-free survival (EFS), along with secondary endpoints of pCR, overall survival (OS), and safety with results available for presentation at SABCS 2024.
Methods Design: This is a phase III, double-blind, placebo-controlled trial evaluating neoadjuvant atezolizumab with NAC followed by adjuvant atezolizumab in Stage II/III TNBC. Patients were stratified by region (North America; Europe), tumor size (1.1-3.0 cm; >3.0 cm), AC/EC schedule (q2w; q3w), and nodal status (positive; negative), then randomized 1:1 to receive atezolizumab/placebo 1200 mg IV every 3 wks concurrently with both sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses with every 3-wk carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 wks (per investigator discretion) for 4 cycles. Following surgery, patients resumed atezolizumab/placebo 1200 mg IV every 3 wks as adjuvant therapy to complete 1 year. Radiotherapy based on local standards was co-administered with atezolizumab/placebo. Patients with RID were allowed to receive adjuvant/post-operative capecitabine or olaparib per investigator discretion. Atezolizumab/placebo could be co-administered with capecitabine but not with olaparib.
Eligibility criteria: Centrally confirmed ER-negative, PR-negative, HER2-negative invasive breast cancer by ASCO/CAP guidelines. The primary tumor must be stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF >55% and no significant cardiac history.
Statistical methods: The study was designed to detect a hazard ratio of 0.7 between atezolizumab and placebo for the primary endpoint of EFS with a 2-sided alpha of 0.05. Secondary endpoints include pCR breast/nodes, distant disease-free survival, OS, safety, and toxicity. Exploratory endpoints include brain metastases-free survival.
Results: 1,550 patients were randomized from December 2017–May 2021. Patient characteristics included age <60 in 79%, primary tumors >3 cm in 41%, clinically node-positive in 41%, and PD-L1 positive in 36%. With a median follow-up of 44 months, the pre-specified number of EFS events for definitive analysis was reached for top-level analyses to be completed by mid-November 2024 and available for presentation at SABCS 2024.
NCT #: NCT03281954
Support: Genentech/Roche
Sequential neoadjuvant chemotherapy (NAC) regimens of taxanes with carboplatin followed by anthracyclines with cyclophosphamide (AC/EC) result in pathological complete responses (pCR) in 55-60% of patients with Stage II/III triple-negative breast cancer (TNBC) who enjoy a favorable prognosis. However, those with residual invasive disease (RID) following NAC have an increased risk of recurrence even with adjuvant capecitabine. Immune checkpoint inhibitors have demonstrated improved outcomes in patients with PD-L1-positive metastatic breast cancer and increased pCR when added to NAC for Stage II/III TNBC, irrespective of PD-L1 status. This trial evaluated the efficacy and safety of adding atezolizumab to NAC followed by atezolizumab as adjuvant therapy to complete 1 year of therapy in Stage II/III TNBC. The required number of events was confirmed on 09/16/2024 to establish the data cut-off for conduct of the planned definitive analysis of the primary endpoint, event-free survival (EFS), along with secondary endpoints of pCR, overall survival (OS), and safety with results available for presentation at SABCS 2024.
Methods Design: This is a phase III, double-blind, placebo-controlled trial evaluating neoadjuvant atezolizumab with NAC followed by adjuvant atezolizumab in Stage II/III TNBC. Patients were stratified by region (North America; Europe), tumor size (1.1-3.0 cm; >3.0 cm), AC/EC schedule (q2w; q3w), and nodal status (positive; negative), then randomized 1:1 to receive atezolizumab/placebo 1200 mg IV every 3 wks concurrently with both sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses with every 3-wk carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 wks (per investigator discretion) for 4 cycles. Following surgery, patients resumed atezolizumab/placebo 1200 mg IV every 3 wks as adjuvant therapy to complete 1 year. Radiotherapy based on local standards was co-administered with atezolizumab/placebo. Patients with RID were allowed to receive adjuvant/post-operative capecitabine or olaparib per investigator discretion. Atezolizumab/placebo could be co-administered with capecitabine but not with olaparib.
Eligibility criteria: Centrally confirmed ER-negative, PR-negative, HER2-negative invasive breast cancer by ASCO/CAP guidelines. The primary tumor must be stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF >55% and no significant cardiac history.
Statistical methods: The study was designed to detect a hazard ratio of 0.7 between atezolizumab and placebo for the primary endpoint of EFS with a 2-sided alpha of 0.05. Secondary endpoints include pCR breast/nodes, distant disease-free survival, OS, safety, and toxicity. Exploratory endpoints include brain metastases-free survival.
Results: 1,550 patients were randomized from December 2017–May 2021. Patient characteristics included age <60 in 79%, primary tumors >3 cm in 41%, clinically node-positive in 41%, and PD-L1 positive in 36%. With a median follow-up of 44 months, the pre-specified number of EFS events for definitive analysis was reached for top-level analyses to be completed by mid-November 2024 and available for presentation at SABCS 2024.
NCT #: NCT03281954
Support: Genentech/Roche
Background:
Sequential neoadjuvant chemotherapy (NAC) regimens of taxanes with carboplatin followed by anthracyclines with cyclophosphamide (AC/EC) result in pathological complete responses (pCR) in 55-60% of patients with Stage II/III triple-negative breast cancer (TNBC) who enjoy a favorable prognosis. However, those with residual invasive disease (RID) following NAC have an increased risk of recurrence even with adjuvant capecitabine. Immune checkpoint inhibitors have demonstrated improved outcomes in patients with PD-L1-positive metastatic breast cancer and increased pCR when added to NAC for Stage II/III TNBC, irrespective of PD-L1 status. This trial evaluated the efficacy and safety of adding atezolizumab to NAC followed by atezolizumab as adjuvant therapy to complete 1 year of therapy in Stage II/III TNBC. The required number of events was confirmed on 09/16/2024 to establish the data cut-off for conduct of the planned definitive analysis of the primary endpoint, event-free survival (EFS), along with secondary endpoints of pCR, overall survival (OS), and safety with results available for presentation at SABCS 2024.
Methods Design: This is a phase III, double-blind, placebo-controlled trial evaluating neoadjuvant atezolizumab with NAC followed by adjuvant atezolizumab in Stage II/III TNBC. Patients were stratified by region (North America; Europe), tumor size (1.1-3.0 cm; >3.0 cm), AC/EC schedule (q2w; q3w), and nodal status (positive; negative), then randomized 1:1 to receive atezolizumab/placebo 1200 mg IV every 3 wks concurrently with both sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses with every 3-wk carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 wks (per investigator discretion) for 4 cycles. Following surgery, patients resumed atezolizumab/placebo 1200 mg IV every 3 wks as adjuvant therapy to complete 1 year. Radiotherapy based on local standards was co-administered with atezolizumab/placebo. Patients with RID were allowed to receive adjuvant/post-operative capecitabine or olaparib per investigator discretion. Atezolizumab/placebo could be co-administered with capecitabine but not with olaparib.
Eligibility criteria: Centrally confirmed ER-negative, PR-negative, HER2-negative invasive breast cancer by ASCO/CAP guidelines. The primary tumor must be stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF >55% and no significant cardiac history.
Statistical methods: The study was designed to detect a hazard ratio of 0.7 between atezolizumab and placebo for the primary endpoint of EFS with a 2-sided alpha of 0.05. Secondary endpoints include pCR breast/nodes, distant disease-free survival, OS, safety, and toxicity. Exploratory endpoints include brain metastases-free survival.
Results: 1,550 patients were randomized from December 2017–May 2021. Patient characteristics included age <60 in 79%, primary tumors >3 cm in 41%, clinically node-positive in 41%, and PD-L1 positive in 36%. With a median follow-up of 44 months, the pre-specified number of EFS events for definitive analysis was reached for top-level analyses to be completed by mid-November 2024 and available for presentation at SABCS 2024.
NCT #: NCT03281954
Support: Genentech/Roche
Sequential neoadjuvant chemotherapy (NAC) regimens of taxanes with carboplatin followed by anthracyclines with cyclophosphamide (AC/EC) result in pathological complete responses (pCR) in 55-60% of patients with Stage II/III triple-negative breast cancer (TNBC) who enjoy a favorable prognosis. However, those with residual invasive disease (RID) following NAC have an increased risk of recurrence even with adjuvant capecitabine. Immune checkpoint inhibitors have demonstrated improved outcomes in patients with PD-L1-positive metastatic breast cancer and increased pCR when added to NAC for Stage II/III TNBC, irrespective of PD-L1 status. This trial evaluated the efficacy and safety of adding atezolizumab to NAC followed by atezolizumab as adjuvant therapy to complete 1 year of therapy in Stage II/III TNBC. The required number of events was confirmed on 09/16/2024 to establish the data cut-off for conduct of the planned definitive analysis of the primary endpoint, event-free survival (EFS), along with secondary endpoints of pCR, overall survival (OS), and safety with results available for presentation at SABCS 2024.
Methods Design: This is a phase III, double-blind, placebo-controlled trial evaluating neoadjuvant atezolizumab with NAC followed by adjuvant atezolizumab in Stage II/III TNBC. Patients were stratified by region (North America; Europe), tumor size (1.1-3.0 cm; >3.0 cm), AC/EC schedule (q2w; q3w), and nodal status (positive; negative), then randomized 1:1 to receive atezolizumab/placebo 1200 mg IV every 3 wks concurrently with both sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses with every 3-wk carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 wks (per investigator discretion) for 4 cycles. Following surgery, patients resumed atezolizumab/placebo 1200 mg IV every 3 wks as adjuvant therapy to complete 1 year. Radiotherapy based on local standards was co-administered with atezolizumab/placebo. Patients with RID were allowed to receive adjuvant/post-operative capecitabine or olaparib per investigator discretion. Atezolizumab/placebo could be co-administered with capecitabine but not with olaparib.
Eligibility criteria: Centrally confirmed ER-negative, PR-negative, HER2-negative invasive breast cancer by ASCO/CAP guidelines. The primary tumor must be stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF >55% and no significant cardiac history.
Statistical methods: The study was designed to detect a hazard ratio of 0.7 between atezolizumab and placebo for the primary endpoint of EFS with a 2-sided alpha of 0.05. Secondary endpoints include pCR breast/nodes, distant disease-free survival, OS, safety, and toxicity. Exploratory endpoints include brain metastases-free survival.
Results: 1,550 patients were randomized from December 2017–May 2021. Patient characteristics included age <60 in 79%, primary tumors >3 cm in 41%, clinically node-positive in 41%, and PD-L1 positive in 36%. With a median follow-up of 44 months, the pre-specified number of EFS events for definitive analysis was reached for top-level analyses to be completed by mid-November 2024 and available for presentation at SABCS 2024.
NCT #: NCT03281954
Support: Genentech/Roche
NSABP B-59/GBG-96-GeparDouze: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy with atezolizumab or placebo followed by adjuvant atezolizumab or placebo in patients with Stage II and III triple-negative breast cancer
Charles Geyer
Abstract
Background:
Sequential neoadjuvant chemotherapy (NAC) regimens of taxanes with carboplatin followed by anthracyclines with cyclophosphamide (AC/EC) result in pathological complete responses (pCR) in 55-60% of patients with Stage II/III triple-negative breast cancer (TNBC) who enjoy a favorable prognosis. However, those with residual invasive disease (RID) following NAC have an increased risk of recurrence even with adjuvant capecitabine. Immune checkpoint inhibitors have demonstrated improved outcomes in patients with PD-L1-positive metastatic breast cancer and increased pCR when added to NAC for Stage II/III TNBC, irrespective of PD-L1 status. This trial evaluated the efficacy and safety of adding atezolizumab to NAC followed by atezolizumab as adjuvant therapy to complete 1 year of therapy in Stage II/III TNBC. The required number of events was confirmed on 09/16/2024 to establish the data cut-off for conduct of the planned definitive analysis of the primary endpoint, event-free survival (EFS), along with secondary endpoints of pCR, overall survival (OS), and safety with results available for presentation at SABCS 2024.
Methods Design: This is a phase III, double-blind, placebo-controlled trial evaluating neoadjuvant atezolizumab with NAC followed by adjuvant atezolizumab in Stage II/III TNBC. Patients were stratified by region (North America; Europe), tumor size (1.1-3.0 cm; >3.0 cm), AC/EC schedule (q2w; q3w), and nodal status (positive; negative), then randomized 1:1 to receive atezolizumab/placebo 1200 mg IV every 3 wks concurrently with both sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses with every 3-wk carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 wks (per investigator discretion) for 4 cycles. Following surgery, patients resumed atezolizumab/placebo 1200 mg IV every 3 wks as adjuvant therapy to complete 1 year. Radiotherapy based on local standards was co-administered with atezolizumab/placebo. Patients with RID were allowed to receive adjuvant/post-operative capecitabine or olaparib per investigator discretion. Atezolizumab/placebo could be co-administered with capecitabine but not with olaparib.
Eligibility criteria: Centrally confirmed ER-negative, PR-negative, HER2-negative invasive breast cancer by ASCO/CAP guidelines. The primary tumor must be stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF >55% and no significant cardiac history.
Statistical methods: The study was designed to detect a hazard ratio of 0.7 between atezolizumab and placebo for the primary endpoint of EFS with a 2-sided alpha of 0.05. Secondary endpoints include pCR breast/nodes, distant disease-free survival, OS, safety, and toxicity. Exploratory endpoints include brain metastases-free survival.
Results: 1,550 patients were randomized from December 2017–May 2021. Patient characteristics included age <60 in 79%, primary tumors >3 cm in 41%, clinically node-positive in 41%, and PD-L1 positive in 36%. With a median follow-up of 44 months, the pre-specified number of EFS events for definitive analysis was reached for top-level analyses to be completed by mid-November 2024 and available for presentation at SABCS 2024.
NCT #: NCT03281954
Support: Genentech/Roche
Sequential neoadjuvant chemotherapy (NAC) regimens of taxanes with carboplatin followed by anthracyclines with cyclophosphamide (AC/EC) result in pathological complete responses (pCR) in 55-60% of patients with Stage II/III triple-negative breast cancer (TNBC) who enjoy a favorable prognosis. However, those with residual invasive disease (RID) following NAC have an increased risk of recurrence even with adjuvant capecitabine. Immune checkpoint inhibitors have demonstrated improved outcomes in patients with PD-L1-positive metastatic breast cancer and increased pCR when added to NAC for Stage II/III TNBC, irrespective of PD-L1 status. This trial evaluated the efficacy and safety of adding atezolizumab to NAC followed by atezolizumab as adjuvant therapy to complete 1 year of therapy in Stage II/III TNBC. The required number of events was confirmed on 09/16/2024 to establish the data cut-off for conduct of the planned definitive analysis of the primary endpoint, event-free survival (EFS), along with secondary endpoints of pCR, overall survival (OS), and safety with results available for presentation at SABCS 2024.
Methods Design: This is a phase III, double-blind, placebo-controlled trial evaluating neoadjuvant atezolizumab with NAC followed by adjuvant atezolizumab in Stage II/III TNBC. Patients were stratified by region (North America; Europe), tumor size (1.1-3.0 cm; >3.0 cm), AC/EC schedule (q2w; q3w), and nodal status (positive; negative), then randomized 1:1 to receive atezolizumab/placebo 1200 mg IV every 3 wks concurrently with both sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses with every 3-wk carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 wks (per investigator discretion) for 4 cycles. Following surgery, patients resumed atezolizumab/placebo 1200 mg IV every 3 wks as adjuvant therapy to complete 1 year. Radiotherapy based on local standards was co-administered with atezolizumab/placebo. Patients with RID were allowed to receive adjuvant/post-operative capecitabine or olaparib per investigator discretion. Atezolizumab/placebo could be co-administered with capecitabine but not with olaparib.
Eligibility criteria: Centrally confirmed ER-negative, PR-negative, HER2-negative invasive breast cancer by ASCO/CAP guidelines. The primary tumor must be stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF >55% and no significant cardiac history.
Statistical methods: The study was designed to detect a hazard ratio of 0.7 between atezolizumab and placebo for the primary endpoint of EFS with a 2-sided alpha of 0.05. Secondary endpoints include pCR breast/nodes, distant disease-free survival, OS, safety, and toxicity. Exploratory endpoints include brain metastases-free survival.
Results: 1,550 patients were randomized from December 2017–May 2021. Patient characteristics included age <60 in 79%, primary tumors >3 cm in 41%, clinically node-positive in 41%, and PD-L1 positive in 36%. With a median follow-up of 44 months, the pre-specified number of EFS events for definitive analysis was reached for top-level analyses to be completed by mid-November 2024 and available for presentation at SABCS 2024.
NCT #: NCT03281954
Support: Genentech/Roche
Background:
Sequential neoadjuvant chemotherapy (NAC) regimens of taxanes with carboplatin followed by anthracyclines with cyclophosphamide (AC/EC) result in pathological complete responses (pCR) in 55-60% of patients with Stage II/III triple-negative breast cancer (TNBC) who enjoy a favorable prognosis. However, those with residual invasive disease (RID) following NAC have an increased risk of recurrence even with adjuvant capecitabine. Immune checkpoint inhibitors have demonstrated improved outcomes in patients with PD-L1-positive metastatic breast cancer and increased pCR when added to NAC for Stage II/III TNBC, irrespective of PD-L1 status. This trial evaluated the efficacy and safety of adding atezolizumab to NAC followed by atezolizumab as adjuvant therapy to complete 1 year of therapy in Stage II/III TNBC. The required number of events was confirmed on 09/16/2024 to establish the data cut-off for conduct of the planned definitive analysis of the primary endpoint, event-free survival (EFS), along with secondary endpoints of pCR, overall survival (OS), and safety with results available for presentation at SABCS 2024.
Methods Design: This is a phase III, double-blind, placebo-controlled trial evaluating neoadjuvant atezolizumab with NAC followed by adjuvant atezolizumab in Stage II/III TNBC. Patients were stratified by region (North America; Europe), tumor size (1.1-3.0 cm; >3.0 cm), AC/EC schedule (q2w; q3w), and nodal status (positive; negative), then randomized 1:1 to receive atezolizumab/placebo 1200 mg IV every 3 wks concurrently with both sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses with every 3-wk carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 wks (per investigator discretion) for 4 cycles. Following surgery, patients resumed atezolizumab/placebo 1200 mg IV every 3 wks as adjuvant therapy to complete 1 year. Radiotherapy based on local standards was co-administered with atezolizumab/placebo. Patients with RID were allowed to receive adjuvant/post-operative capecitabine or olaparib per investigator discretion. Atezolizumab/placebo could be co-administered with capecitabine but not with olaparib.
Eligibility criteria: Centrally confirmed ER-negative, PR-negative, HER2-negative invasive breast cancer by ASCO/CAP guidelines. The primary tumor must be stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF >55% and no significant cardiac history.
Statistical methods: The study was designed to detect a hazard ratio of 0.7 between atezolizumab and placebo for the primary endpoint of EFS with a 2-sided alpha of 0.05. Secondary endpoints include pCR breast/nodes, distant disease-free survival, OS, safety, and toxicity. Exploratory endpoints include brain metastases-free survival.
Results: 1,550 patients were randomized from December 2017–May 2021. Patient characteristics included age <60 in 79%, primary tumors >3 cm in 41%, clinically node-positive in 41%, and PD-L1 positive in 36%. With a median follow-up of 44 months, the pre-specified number of EFS events for definitive analysis was reached for top-level analyses to be completed by mid-November 2024 and available for presentation at SABCS 2024.
NCT #: NCT03281954
Support: Genentech/Roche
Sequential neoadjuvant chemotherapy (NAC) regimens of taxanes with carboplatin followed by anthracyclines with cyclophosphamide (AC/EC) result in pathological complete responses (pCR) in 55-60% of patients with Stage II/III triple-negative breast cancer (TNBC) who enjoy a favorable prognosis. However, those with residual invasive disease (RID) following NAC have an increased risk of recurrence even with adjuvant capecitabine. Immune checkpoint inhibitors have demonstrated improved outcomes in patients with PD-L1-positive metastatic breast cancer and increased pCR when added to NAC for Stage II/III TNBC, irrespective of PD-L1 status. This trial evaluated the efficacy and safety of adding atezolizumab to NAC followed by atezolizumab as adjuvant therapy to complete 1 year of therapy in Stage II/III TNBC. The required number of events was confirmed on 09/16/2024 to establish the data cut-off for conduct of the planned definitive analysis of the primary endpoint, event-free survival (EFS), along with secondary endpoints of pCR, overall survival (OS), and safety with results available for presentation at SABCS 2024.
Methods Design: This is a phase III, double-blind, placebo-controlled trial evaluating neoadjuvant atezolizumab with NAC followed by adjuvant atezolizumab in Stage II/III TNBC. Patients were stratified by region (North America; Europe), tumor size (1.1-3.0 cm; >3.0 cm), AC/EC schedule (q2w; q3w), and nodal status (positive; negative), then randomized 1:1 to receive atezolizumab/placebo 1200 mg IV every 3 wks concurrently with both sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses with every 3-wk carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 wks (per investigator discretion) for 4 cycles. Following surgery, patients resumed atezolizumab/placebo 1200 mg IV every 3 wks as adjuvant therapy to complete 1 year. Radiotherapy based on local standards was co-administered with atezolizumab/placebo. Patients with RID were allowed to receive adjuvant/post-operative capecitabine or olaparib per investigator discretion. Atezolizumab/placebo could be co-administered with capecitabine but not with olaparib.
Eligibility criteria: Centrally confirmed ER-negative, PR-negative, HER2-negative invasive breast cancer by ASCO/CAP guidelines. The primary tumor must be stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF >55% and no significant cardiac history.
Statistical methods: The study was designed to detect a hazard ratio of 0.7 between atezolizumab and placebo for the primary endpoint of EFS with a 2-sided alpha of 0.05. Secondary endpoints include pCR breast/nodes, distant disease-free survival, OS, safety, and toxicity. Exploratory endpoints include brain metastases-free survival.
Results: 1,550 patients were randomized from December 2017–May 2021. Patient characteristics included age <60 in 79%, primary tumors >3 cm in 41%, clinically node-positive in 41%, and PD-L1 positive in 36%. With a median follow-up of 44 months, the pre-specified number of EFS events for definitive analysis was reached for top-level analyses to be completed by mid-November 2024 and available for presentation at SABCS 2024.
NCT #: NCT03281954
Support: Genentech/Roche
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