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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)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Placebo
Doxorubicin
Cyclophosphamide
Paclitaxel
Trastuzumab
Pertuzumab
Trastuzumab Emtansine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HCA Midwest Division
  • New York University Medical Center PRIME; NYU Langone Medical Center
  • Tennessee Oncology
  • Hospital Sao Rafael - HSR
  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
  • Hospital Sao Lucas - PUCRS
  • Hospital Nossa Senhora da Conceicao
  • Hospital Perola Byington
  • Tom Baker Cancer Centre-Calgary
  • BCCA-Vancouver Cancer Centre
  • Jewish General Hospital
  • Hopital du Saint Sacrement
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
  • Sankt Elisabeth Krankenhaus; Gynaekology
  • Rotkreuzklinikum München; Frauenklinik
  • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
  • St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
  • Universitätsfrauenklinik Ulm; Abteilung Gynäkologie
  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
  • Università degli Studi Federico II; Clinica di Oncologia Medica
  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
  • Policlinico Universitario Agostino Gemelli
  • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
  • ASST DI MONZA; Oncologia Medica
  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
  • National Hospital Organization Shikoku Cancer Center
  • Fukushima Medical University Hospital
  • Hiroshima City Hiroshima Citizens Hospital
  • Hiroshima University Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Hyogo Cancer Center
  • Kanagawa Cancer Center
  • Tokai University Hospital
  • Kumamoto Shinto General Hospital
  • Niigata Cancer Center Hospital
  • Saitama Medical University International Medical Center
  • Toranomon Hospital
  • Showa University Hospital
  • Gachon University Gil Medical Center
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Samsung Medical Centre; Oncology
  • Instytut "Centrum Zdrowia Matki Polki"; Klinika Onkologii
  • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi
  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej
  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
  • FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER
  • City Clinical Oncology Hospital
  • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
  • Blokhin Cancer Research Center; Combined Treatment
  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
  • Petrov Research Inst. of Oncology
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
  • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
  • Hospital Clinico de Granada; Servicio de Oncologia
  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
  • Clinica Universidad de Navarra Madrid; Servicio de Oncología
  • Centro Integral Oncologico Clara Campal; Servicio de Oncología
  • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • China Medical University Hospital; Surgery
  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
  • Mackay Memorial Hospital; Dept of Surgery
  • Chang Gung Medical Foundation - Linkou; Dept of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atezolizumab +ddAC-PacHP

Placebo + ddAC-PacHP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Pathological Complete Response (pCR) in the PD-L1-Positive Population (IC 1/2/3)
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
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
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
pCR (ypT0/is ypN0) in the IC 0 Population
Event-Free Survival (EFS)
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)
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)
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)
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
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
Maximum Serum Concentration (Cmax) of Atezolizumab
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Minimum Serum Concentration (Cmin) of Atezolizumab
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
Trough Concentration (Ctrough) for Pertuzumab and Trastuzumab in Serum
Cmax of Trastuzumab Emtansine in Serum
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Cmin of Trastuzumab Emtansine in Serum
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
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
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
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
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
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
DFS Based on PIK3CA Mutation Status
OS Based on PIK3CA Mutation Status

Full Information

First Posted
October 30, 2018
Last Updated
September 14, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03726879
Brief Title
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
Acronym
IMpassion050
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
February 5, 2021 (Actual)
Study Completion Date
August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
454 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab +ddAC-PacHP
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + ddAC-PacHP
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to atezolizumab will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin
Intervention Description
Doxorubicin will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan, Neosar
Intervention Description
Cyclophosphamide will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Paclitaxel will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Description
Trastuzumab will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta
Intervention Description
Pertuzumab will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab Emtansine
Other Intervention Name(s)
Kadcyla
Intervention Description
Participants without pCR have the option of receiving adjuvant atezolizumab/placebo combined with Trastuzumab Emtansine 3.6 mg/kg IV Q3W.
Primary Outcome Measure Information:
Title
Percentage of Participants With Pathological Complete Response (pCR) in the PD-L1-Positive Population (IC 1/2/3)
Description
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).
Time Frame
From randomization to approximately 6 months
Title
pCR in the ITT Population
Description
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).
Time Frame
From randomization to approximately 6 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With pCR Based on Hormone Receptor Status
Description
pCR (ypT0/is ypN0) based upon hormone receptor status (estrogen receptor [ER]/progesterone receptor [PgR] positive or ER/PgR negative).
Time Frame
From randomization to approximately 24 months
Title
Percentage of Participants With pCR in the PD-L1-Negative Population
Description
pCR (ypT0/is ypN0) in the IC 0 Population
Time Frame
From randomization to approximately 24 months
Title
Event-Free Survival (EFS)
Description
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).
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)
Title
Disease-Free Survival (DFS)
Description
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).
Time Frame
Time from surgery to first documented disease recurrence or death from any cause (up to approximately 54 months)
Title
Overall Survival (OS)
Description
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).
Time Frame
From randomization to date of death from any cause (up to approximately 54 months)
Title
Mean Changes From Baseline in Function (Role, Physical)
Description
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).
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.
Title
Mean Changes From Baseline in Global Health Status
Description
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).
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.
Title
Percentage of Participants With Adverse Events
Time Frame
From randomization up until clinical cut-off date (approximately 24 months)
Title
Maximum Serum Concentration (Cmax) of Atezolizumab
Description
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Time Frame
30 minutes post infusion on Day 1 Cycle (C) 1.
Title
Minimum Serum Concentration (Cmin) of Atezolizumab
Description
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
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).
Title
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).
Title
Cmax of Trastuzumab Emtansine in Serum
Description
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
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).
Title
Cmin of Trastuzumab Emtansine in Serum
Description
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
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).
Title
Number of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) to Atezolizumab
Description
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).
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).
Title
Number of Participants With Treatment-Emergent ADAs to Trastuzumab
Description
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).
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).
Title
Number of Participants With Treatment-Emergent ADAs to Pertuzumab
Description
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).
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).
Title
Number of Participants With Treatment-Emergent ADAs to Trastuzumab Emtansine
Description
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).
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).
Title
Percentage of Participants With pCR Based on PIK3CA Mutation Status
Description
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).
Time Frame
From randomization to approximately 24 months
Title
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)
Title
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)
Title
OS Based on PIK3CA Mutation Status
Time Frame
From randomization to date of death from any cause (up to approximately 54 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
HCA Midwest Division
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
New York University Medical Center PRIME; NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Hospital Sao Rafael - HSR
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Hospital Perola Byington
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Tom Baker Cancer Centre-Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
BCCA-Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hopital du Saint Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
City
Freiburg
ZIP/Postal Code
79110
Country
Germany
Facility Name
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Facility Name
Sankt Elisabeth Krankenhaus; Gynaekology
City
Leipzig
ZIP/Postal Code
04277
Country
Germany
Facility Name
Rotkreuzklinikum München; Frauenklinik
City
Muenchen
ZIP/Postal Code
80637
Country
Germany
Facility Name
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Universitätsfrauenklinik Ulm; Abteilung Gynäkologie
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Università degli Studi Federico II; Clinica di Oncologia Medica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
ASST DI MONZA; Oncologia Medica
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo Cancer Center
City
Hyogo
ZIP/Postal Code
673-0021
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kumamoto Shinto General Hospital
City
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Showa University Hospital
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Centre; Oncology
City
Seoul
ZIP/Postal Code
135-170
Country
Korea, Republic of
Facility Name
Instytut "Centrum Zdrowia Matki Polki"; Klinika Onkologii
City
?ód?
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej
City
Grudzi?dz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER
City
Obninsk
State/Province
Kaluga
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
City Clinical Oncology Hospital
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center; Combined Treatment
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Petrov Research Inst. of Oncology
City
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Sant Andreu de La Barca
State/Province
Barcelona
ZIP/Postal Code
08740
Country
Spain
Facility Name
Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital Clinico de Granada; Servicio de Oncologia
City
Granada
ZIP/Postal Code
18016
Country
Spain
Facility Name
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
City
Lerida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Clinica Universidad de Navarra Madrid; Servicio de Oncología
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal; Servicio de Oncología
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
China Medical University Hospital; Surgery
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
City
Taipei City
ZIP/Postal Code
11259
Country
Taiwan
Facility Name
Mackay Memorial Hospital; Dept of Surgery
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou; Dept of Surgery
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).
Citations:
PubMed Identifier
35763704
Citation
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.
Results Reference
derived

Learn more about this trial

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

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