A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer (IMpassion050)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03726879

Recruitment Status : Active, not recruiting

First Posted : November 1, 2018

Results First Posted : March 25, 2022

Last Update Posted : February 21, 2023

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Chugai Pharmaceutical

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Description

Brief Summary:

This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Atezolizumab Drug: Placebo Drug: Doxorubicin Drug: Cyclophosphamide Drug: Paclitaxel Drug: Trastuzumab Drug: Pertuzumab Drug: Trastuzumab Emtansine	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	454 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Care Provider)
Primary Purpose:	Treatment
Official Title:	A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
Actual Study Start Date :	January 11, 2019
Actual Primary Completion Date :	February 5, 2021
Estimated Study Completion Date :	August 24, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Cyclophosphamide Doxorubicin Paclitaxel Trastuzumab Pertuzumab Atezolizumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Atezolizumab +ddAC-PacHP Participants will receive atezolizumab (atezo) 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by atezo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8mg/kg IV loading dose) Q3W for 4 cycles, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants will continue to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant and adjuvant setting: atezo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who do not achieve pCR have option of receiving blinded atezo+trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL dated 3 Feb 2021 treatment with atezo must be discontinued.	Drug: Atezolizumab Atezolizumab will be administered as per the schedule specified in the respective arm. Other Name: Tecentriq Drug: Doxorubicin Doxorubicin will be administered as per the schedule specified in the respective arm. Other Name: Adriamycin Drug: Cyclophosphamide Cyclophosphamide will be administered as per the schedule specified in the respective arm. Other Names: Cytoxan Neosar Drug: Paclitaxel Paclitaxel will be administered as per the schedule specified in the respective arm. Other Name: Taxol Drug: Trastuzumab Trastuzumab will be administered as per the schedule specified in the respective arm. Other Name: Herceptin Drug: Pertuzumab Pertuzumab will be administered as per the schedule specified in the respective arm. Other Name: Perjeta Drug: Trastuzumab Emtansine Participants without pCR have the option of receiving adjuvant atezolizumab/placebo combined with Trastuzumab Emtansine 3.6 mg/kg IV Q3W. Other Name: Kadcyla
Placebo Comparator: Placebo + ddAC-PacHP Participants will receive placebo 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by placebo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W for 4 cycles & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants will continue to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant & adjuvant setting: placebo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who do not achieve pCR have option of receiving blinded atezolizumab + trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL, dated 3 Feb 2021 treatment with placebo must be discontinued.	Drug: Placebo Placebo matched to atezolizumab will be administered as per the schedule specified in the respective arm. Drug: Doxorubicin Doxorubicin will be administered as per the schedule specified in the respective arm. Other Name: Adriamycin Drug: Cyclophosphamide Cyclophosphamide will be administered as per the schedule specified in the respective arm. Other Names: Cytoxan Neosar Drug: Paclitaxel Paclitaxel will be administered as per the schedule specified in the respective arm. Other Name: Taxol Drug: Trastuzumab Trastuzumab will be administered as per the schedule specified in the respective arm. Other Name: Herceptin Drug: Pertuzumab Pertuzumab will be administered as per the schedule specified in the respective arm. Other Name: Perjeta Drug: Trastuzumab Emtansine Participants without pCR have the option of receiving adjuvant atezolizumab/placebo combined with Trastuzumab Emtansine 3.6 mg/kg IV Q3W. Other Name: Kadcyla

Arm

Intervention/treatment

Experimental: Atezolizumab +ddAC-PacHP

Participants will receive atezolizumab (atezo) 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by atezo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8mg/kg IV loading dose) Q3W for 4 cycles, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants will continue to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant and adjuvant setting: atezo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who do not achieve pCR have option of receiving blinded atezo+trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL dated 3 Feb 2021 treatment with atezo must be discontinued.

Drug: Atezolizumab

Atezolizumab will be administered as per the schedule specified in the respective arm.

Other Name: Tecentriq

Drug: Doxorubicin

Doxorubicin will be administered as per the schedule specified in the respective arm.

Other Name: Adriamycin

Drug: Cyclophosphamide

Cyclophosphamide will be administered as per the schedule specified in the respective arm.

Other Names:

Cytoxan
Neosar

Drug: Paclitaxel

Paclitaxel will be administered as per the schedule specified in the respective arm.

Other Name: Taxol

Drug: Trastuzumab

Trastuzumab will be administered as per the schedule specified in the respective arm.

Other Name: Herceptin

Drug: Pertuzumab

Pertuzumab will be administered as per the schedule specified in the respective arm.

Other Name: Perjeta

Drug: Trastuzumab Emtansine

Participants without pCR have the option of receiving adjuvant atezolizumab/placebo combined with Trastuzumab Emtansine 3.6 mg/kg IV Q3W.

Other Name: Kadcyla

Placebo Comparator: Placebo + ddAC-PacHP

Participants will receive placebo 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by placebo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W for 4 cycles & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants will continue to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant & adjuvant setting: placebo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who do not achieve pCR have option of receiving blinded atezolizumab + trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL, dated 3 Feb 2021 treatment with placebo must be discontinued.

Drug: Placebo

Placebo matched to atezolizumab will be administered as per the schedule specified in the respective arm.

Drug: Doxorubicin

Doxorubicin will be administered as per the schedule specified in the respective arm.

Other Name: Adriamycin

Drug: Cyclophosphamide

Cyclophosphamide will be administered as per the schedule specified in the respective arm.

Other Names:

Cytoxan
Neosar

Drug: Paclitaxel

Paclitaxel will be administered as per the schedule specified in the respective arm.

Other Name: Taxol

Drug: Trastuzumab

Trastuzumab will be administered as per the schedule specified in the respective arm.

Other Name: Herceptin

Drug: Pertuzumab

Pertuzumab will be administered as per the schedule specified in the respective arm.

Other Name: Perjeta

Drug: Trastuzumab Emtansine

Participants without pCR have the option of receiving adjuvant atezolizumab/placebo combined with Trastuzumab Emtansine 3.6 mg/kg IV Q3W.

Other Name: Kadcyla

Outcome Measures

Primary Outcome Measures :

Percentage of Participants With Pathological Complete Response (pCR) in the PD-L1-Positive Population (IC 1/2/3) [ Time Frame: From randomization to approximately 6 months ]
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST) (i.e., ypT0/is ypN0 in the current American Joint Committee on Cancer [AJCC] staging system, 8th edition). Treatment comparison was made using Cochran-Mantel-Haenszel test stratified by disease stage (T2 vs. T3-4) and hormone receptor status (estrogen receptor (ER) positive and/or progesterone receptor (PgR) positive vs. ER negative and PgR negative).
pCR in the ITT Population [ Time Frame: From randomization to approximately 6 months ]
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST) (i.e., ypT0/is ypN0 in the current American Joint Committee on Cancer [AJCC] staging system, 8th edition). Treatment comparison was made using Cochran-Mantel-Haenszel test stratified by disease stage (T2 vs. T3-4) and hormone receptor status (ER positive and/or PgR positive vs. ER negative and PgR negative).

Secondary Outcome Measures :

Percentage of Participants With pCR Based on Hormone Receptor Status [ Time Frame: From randomization to approximately 24 months ]
pCR (ypT0/is ypN0) based upon hormone receptor status (estrogen receptor [ER]/progesterone receptor [PgR] positive or ER/PgR negative).
Percentage of Participants With pCR in the PD-L1-Negative Population [ Time Frame: From randomization to approximately 24 months ]
pCR (ypT0/is ypN0) in the IC 0 Population
Event-Free Survival (EFS) [ Time Frame: From randomization to first documented disease recurrence, unequivocal tumor progression determined by the treating investigator, or death from any cause (up to approximately 54 months) ]
EFS defined as the time from randomization to the first documented disease recurrence, unequivocal tumor progression determined by the treating investigator, or death from any cause, whichever occurs first, in all patients and based upon hormone receptor status (ER/PgR positive or ER/PgR negative) and PD-L1 status (IC 0; IC 1/2/3).
Disease-Free Survival (DFS) [ Time Frame: Time from surgery to first documented disease recurrence or death from any cause (up to approximately 54 months) ]
DFS defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first, in all patients who undergo surgery and based upon hormone receptor status (ER/PgR positive or ER/PgR negative) and PD-L1 status (IC 0; IC 1/2/3).
Overall Survival (OS) [ Time Frame: From randomization to date of death from any cause (up to approximately 54 months) ]
OS defined as the time from randomization to death from any cause in all patients and based upon hormone receptor status (ER/PgR positive or ER/PgR negative) and PD-L1 status (IC 0; IC 1/2/3).
Mean Changes From Baseline in Function (Role, Physical) [ Time Frame: Baseline; Day 1 of Cycle 1-9, on Day 1 of every other cycle thereafter until Cycle 22; at the treatment discontinuation or early termination visit and follow up visit. Cycle 1-4, each cycle is 14 days. Cycle 5-22, each cycle is 21 days. ]
EORTC QLQ-C30 is a self-reported questionnaire that included functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), global health scale/quality of life (GHS/QOL) and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Questions 1-28 on the QLQ-C30 were on a 4-point scale (1=Not at All to 4=Very Much). Questions 29-30 (GHS scale) were on a 7-point scale (1=Very Poor to 7=Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement).
Mean Changes From Baseline in Global Health Status [ Time Frame: Baseline; Day 1 of Cycle 1-9, on Day 1 of every other cycle thereafter until Cycle 22; at the treatment discontinuation or early termination visit and follow up visit. Cycle 1-4, each cycle is 14 days. Cycle 5-22, each cycle is 21 days. ]
EORTC QLQ-C30 is a self-reported questionnaire that included functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), GHS/QOL and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Questions 1-28 on the QLQ-C30 were on a 4-point scale (1=Not at All to 4=Very Much). Questions 29-30 (GHS scale) were on a 7-point scale (1=Very Poor to 7=Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement).
Percentage of Participants With Adverse Events [ Time Frame: From randomization up until clinical cut-off date (approximately 24 months) ]
Maximum Serum Concentration (Cmax) of Atezolizumab [ Time Frame: 30 minutes post infusion on Day 1 Cycle (C) 1. ]
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Minimum Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Pre-dose on Day 1 Cycle (C) 2, 3, 4, 8, 12, 16, ATDV (an average of 1 year). C 2-4, each C is 14 days. C 8-16, each C is 21 days. With protocol version 5, collection is only required ATDV/completion (an average of 1 year). ]
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
Trough Concentration (Ctrough) for Pertuzumab and Trastuzumab in Serum [ Time Frame: Pre-dose on Day 1 Cycle (C) 8, 12, and at treatment discontinuation visit (ATDV) (an average of 1 year). C 1-4, each C is 14 days. C 8-12, each C is 21 days. With protocol version 5, collection is only required ATDV/completion (an average of 1 year). ]
Cmax of Trastuzumab Emtansine in Serum [ Time Frame: Day 1 of Cycle 9 and Cycle 12, at treatment disontinuation visit (an average of 1 year). Cycle 9 and 12 are each 21 days. With protocol version 5, collection is only required at the time of treatment discontinuation/completion (an average of 1 year). ]
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Cmin of Trastuzumab Emtansine in Serum [ Time Frame: Day 1 of Cycle 9 and Cycle 12, at treatment disontinuation visit (an average of 1 year). Cycle 9 and 12 are each 21 days. With protocol version 5, collection is only required at the time of treatment discontinuation/completion (an average of 1 year). ]
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
Number of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: Day 1 Cycle (C) 1, 2, 3, 4, 8, 12, 16, at treatment discontinuation visit (ATDV) (an average of 1 year). C 1-4, each C is 14 days. C 8-16, each C is 21 days. With protocol version 5, collection is only required ATDV/completion (an average of 1 year). ]
Participants were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 titer units greater than the titer of the baseline sample (treatment unaffected).
Number of Participants With Treatment-Emergent ADAs to Trastuzumab [ Time Frame: Day 1 Cycle (C) 1, 8, 12 and at treatment discontinuation visit (ATDV) (an average of 1 year). C 1-4, each C is 14 days. C 8-12, each C is 21 days. With protocol version 5, collection is only required ATDV/completion (an average of 1 year). ]
Participants were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 titer units greater than the titer of the baseline sample (treatment unaffected).
Number of Participants With Treatment-Emergent ADAs to Pertuzumab [ Time Frame: Day 1 of Cycle (C) 1, 8, 12, and at treatment discontinuation visit (ATDV) (an average of 1 year). C 1-4, each C is 14 days. C 8-12, each C is 21 days. With protocol version 5, collection is only required ATDV/completion (an average of 1 year). ]
Participants were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 titer units greater than the titer of the baseline sample (treatment unaffected).
Number of Participants With Treatment-Emergent ADAs to Trastuzumab Emtansine [ Time Frame: Day 1 of Cycle 9 and Cycle 12, at treatment disontinuation visit (an average of 1 year). Cycle 9 and 12 are each 21 days. With protocol version 5, collection is only required at the time of treatment discontinuation/completion (an average of 1 year). ]
Participants were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 titer units greater than the titer of the baseline sample (treatment unaffected).
Percentage of Participants With pCR Based on PIK3CA Mutation Status [ Time Frame: From randomization to approximately 24 months ]
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST) (i.e., ypT0/is ypN0 in the current American Joint Committee on Cancer [AJCC] staging system, 8th edition).
EFS Based on PIK3CA Mutation Status [ Time Frame: From randomization to first documented disease recurrence, unequivocal tumor progression determined by the treating investigator, or death from any cause (up to approximately 54 months) ]
DFS Based on PIK3CA Mutation Status [ Time Frame: Time from surgery to first documented disease recurrence or death from any cause (up to approximately 54 months) ]
OS Based on PIK3CA Mutation Status [ Time Frame: From randomization to date of death from any cause (up to approximately 54 months) ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of HER2-positive breast cancer, and hormonal and PD-L1 status, as documented through central testing of a representative tumor tissue specimen
Primary breast tumor size of > 2 cm by any radiographic measurement
Stage at presentation: T2-T4, N1-N3, M0 as determined by AJCC staging system, 8th edition
Pathologic confirmation of nodal involvement with malignancy must be determined by fine needle aspiration or core-needle biopsy. Surgical excision of lymph nodes is not permitted.
Patients with multifocal tumors are eligible provided at least one focus is sampled and centrally confirmed as HER2-positive.
Patients with multicentric tumors are eligible provided all discrete lesions are sampled and centrally confirmed as HER2-positive.
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Baseline LVEF >= 55% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans
Adequate hematologic and end-organ function obtained within 14 days prior to initiation of study treatment
For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

Prior history of invasive breast cancer
Stage IV (metastatic) breast cancer
Patients with synchronous bilateral invasive breast cancer
Prior systemic therapy for treatment of breast cancer
Previous therapy with anthracyclines or taxanes for any malignancy
Ulcerating or inflammatory breast cancer
Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of neoadjuvant therapy
History of other malignancy within 5 years prior to screening, with the exception of those patients who have a negligible risk of metastasis or death
Cardiopulmonary dysfunction
Dyspnea at rest
Active or history of autoimmune disease or immune deficiency
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab/placebo, 6 months after the final dose of doxorubicin, 12 months after the final dose of cyclophosphamide, 6 months after the final dose of paclitaxel, or 7 months after the final dose of trastuzumab, pertuzumab, or trastuzumab emtansine whichever occurs last

Exclusion Criteria Related to Trastuzumab Emtansine in the Adjuvant Setting:

Patients who achieved pCR
Evidence of clinically evident gross residual or recurrent disease following neoadjuvant therapy and surgery
Unable to complete surgery with curative intent after conclusion of neoadjuvant systemic therapy
Patient discontinued treatment with trastuzumab because of toxicity during the neoadjuvant phase of the study
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, or sclerosis cholangitis
Patients with Grade >=2 peripheral neuropathy
Prior treatment with trastuzumab emtansine

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726879

Locations

Show 76 study locations

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United States, Missouri
HCA Midwest Division
Kansas City, Missouri, United States, 64132
United States, New York
New York University Medical Center PRIME; NYU Langone Medical Center
New York, New York, United States, 10016
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Brazil
Hospital Sao Rafael - HSR
Salvador, BA, Brazil, 41253-190
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiania, GO, Brazil, 74605-070
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Hospital Nossa Senhora da Conceicao
Porto Alegre, RS, Brazil, 91350-200
Hospital Perola Byington
Sao Paulo, SP, Brazil, 01317-000
Canada, Alberta
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Hopital du Saint Sacrement
Quebec City, Quebec, Canada, G1S 4L8
Czechia
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia, 779 00
Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, Germany, 45136
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg, Germany, 79110
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, Germany, 20357
Sankt Elisabeth Krankenhaus; Gynaekology
Leipzig, Germany, 04277
Rotkreuzklinikum München; Frauenklinik
Muenchen, Germany, 80637
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
Münster, Germany, 48149
St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
Paderborn, Germany, 33098
Universitätsfrauenklinik Ulm; Abteilung Gynäkologie
Ulm, Germany, 89075
Italy
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
Napoli, Campania, Italy, 80131
Università degli Studi Federico II; Clinica di Oncologia Medica
Napoli, Campania, Italy, 80131
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli-Venezia Giulia, Italy, 33081
Policlinico Universitario Agostino Gemelli
Roma, Lazio, Italy, 00168
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
Brescia, Lombardia, Italy, 25123
ASST DI MONZA; Oncologia Medica
Monza, Lombardia, Italy, 20900
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano, Lombardia, Italy, 20089
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo, Piemonte, Italy, 10060
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova, Veneto, Italy, 35128
Japan
National Hospital Organization Shikoku Cancer Center
Ehime, Japan, 791-0280
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan, 730-8518
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
National Hospital Organization Hokkaido Cancer Center
Hokkaido, Japan, 003-0804
Hyogo Cancer Center
Hyogo, Japan, 673-0021
Kanagawa Cancer Center
Kanagawa, Japan, 241-8515
Tokai University Hospital
Kanagawa, Japan, 259-1193
Kumamoto Shinto General Hospital
Kumamoto, Japan, 862-8655
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Saitama Medical University International Medical Center
Saitama, Japan, 350-1298
Toranomon Hospital
Tokyo, Japan, 105-8470
Showa University Hospital
Tokyo, Japan, 142-8666
Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Korea University Anam Hospital
Seoul, Korea, Republic of, 02841
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Samsung Medical Centre; Oncology
Seoul, Korea, Republic of, 135-170
Poland
Instytut "Centrum Zdrowia Matki Polki"; Klinika Onkologii
?ód?, Poland, 93-338
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi
Gliwice, Poland, 44-101
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej
Grudzi?dz, Poland, 86-300
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Kraków, Poland, 30-688
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
Warszawa, Poland, 02-781
Russian Federation
FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER
Obninsk, Kaluga, Russian Federation, 249036
Petrov Research Inst. of Oncology
Pesochny, Leningrad, Russian Federation, 197758
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
Moskva, Moskovskaja Oblast, Russian Federation, 111123
Blokhin Cancer Research Center; Combined Treatment
Moskva, Moskovskaja Oblast, Russian Federation, 115478
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan, Tatarstan, Russian Federation, 420029
City Clinical Oncology Hospital
Moscow, Russian Federation, 143423
Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain, 08916
Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
El Palmar, Murcia, Spain, 30120
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra, Spain, 31008
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, Spain, 08036
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
Burgos, Spain, 09006
Hospital Clinico de Granada; Servicio de Oncologia
Granada, Spain, 18016
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaen, Spain, 23007
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lerida, Spain, 25198
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, Spain, 28027
Centro Integral Oncologico Clara Campal; Servicio de Oncología
Madrid, Spain, 28050
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, Spain, 41013
Taiwan
China Medical University Hospital; Surgery
Taichung, Taiwan, 404
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei City, Taiwan, 11259
Mackay Memorial Hospital; Dept of Surgery
Taipei, Taiwan, 104
Chang Gung Medical Foundation - Linkou; Dept of Surgery
Taoyuan, Taiwan, 333

Sponsors and Collaborators

Hoffmann-La Roche

Chugai Pharmaceutical

Investigators

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Study Director:	Clinical Trials	Hoffmann-La Roche

Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol [PDF] February 12, 2021

Statistical Analysis Plan [PDF] November 20, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Huober J, Barrios CH, Niikura N, Jarzab M, Chang YC, Huggins-Puhalla SL, Pedrini J, Zhukova L, Graupner V, Eiger D, Henschel V, Gochitashvili N, Lambertini C, Restuccia E, Zhang H; IMpassion050 Trial Investigators. Atezolizumab With Neoadjuvant Anti-Human Epidermal Growth Factor Receptor 2 Therapy and Chemotherapy in Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: Primary Results of the Randomized Phase III IMpassion050 Trial. J Clin Oncol. 2022 Sep 1;40(25):2946-2956. doi: 10.1200/JCO.21.02772. Epub 2022 Jun 28.

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Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT03726879
Other Study ID Numbers:	BO40747
First Posted:	November 1, 2018 Key Record Dates
Results First Posted:	March 25, 2022
Last Update Posted:	February 21, 2023
Last Verified:	February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Maytansine Ado-Trastuzumab Emtansine Cyclophosphamide Doxorubicin Trastuzumab Atezolizumab Pertuzumab Antineoplastic Agents, Phytogenic Antineoplastic Agents	Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors

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