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A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer (IMpassion031)

Primary Purpose

Triple-negative Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Placebo
Nab-paclitaxel
Doxorubicin
Cyclophosphamide
Filgrastim
Pegfilgrastim
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-negative Breast Cancer

Eligibility Criteria

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

Inclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically documented TNBC (negative human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PgR] status)
  • Confirmed tumor programmed death-ligand 1 (PD-L1) evaluation as documented through central testing of a representative tumor tissue specimen
  • Primary breast tumor size of greater than (>) 2 centimeters (cm) by at least one radiographic or clinical measurement
  • Stage at presentation: cT2-cT4, cN0-cN3, cM0
  • Participant agreement to undergo appropriate surgical management including axillary lymph node surgery and partial or total mastectomy after completion of neoadjuvant treatment
  • Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans
  • Adequate hematologic and end-organ function
  • Representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PgR, and HER2 negativity
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
  • Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study drug

Exclusion criteria:

  • Prior history of invasive breast cancer
  • Stage 4 (metastatic) breast cancer
  • Prior systemic therapy for treatment and prevention of breast cancer
  • Previous therapy with anthracyclines or taxanes for any malignancy
  • History of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy >5 years prior to diagnosis of current breast cancer
  • History of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed >5 years prior to diagnosis of current breast cancer
  • Bilateral breast cancer
  • Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
  • 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 with a negligible risk of metastasis or death
  • Cardiopulmonary dysfunction
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
  • Known allergy or hypersensitivity to the components of the formulations of atezolizumab, nab-paclitaxel, cyclophosphamide, or doxorubicin, filgrastim or pegfilgrastim
  • Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus, and dermatologic manifestations of eczema, psoriasis, lichen simplex chronicus, or vitiligo (e.g., participants with psoriatic arthritis are excluded)
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Positive human immunodeficiency virus (HIV) test at screening
  • Active hepatitis B and hepatitis C virus infection
  • Active tuberculosis
  • Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, except prophylactic antibiotics
  • Major surgical procedure within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
  • Prior allogeneic stem cell or solid organ transplantation
  • Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint-blockade therapies, including anti-cluster of differentiation 40 (anti-CD40), anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medications during the study
  • History of cerebrovascular accident within 12 months prior to randomization
  • Pregnant or lactating, or intending to become pregnant during the study

Sites / Locations

  • Stanford University Medical Center
  • Norwalk Hospital
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  • Mercy Medical Center
  • HCA Midwest Division
  • The Valley Hospital; Valley Medical Group
  • Memorial Sloan Kettering Cancer Center
  • Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street
  • Tennessee Oncology
  • Vanderbilt Breast Center at One Hundred Oaks
  • The Center for Cancer and Blood Disorders - Fort Worth
  • Cancer Care Northwest
  • Monash Medical Centre
  • Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
  • Cliniques Universitaires St-Luc
  • UZ Leuven Gasthuisberg
  • Clinique Ste-Elisabeth
  • Sint Augustinus Wilrijk
  • Santa Casa de Misericordia de Salvador
  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
  • CETUS Hospital Dia Oncologia
  • Iop Instituto de Oncologia Do Parana
  • Clinicas Oncologicas Integradas - COI
  • Hospital Sao Lucas - PUCRS
  • Hospital Nossa Senhora da Conceicao
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • Jewish General Hospital
  • Hopital Sacre-Coeur Research Centre
  • Hopital du Saint Sacrement
  • Hochwaldkrankenhaus
  • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
  • Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
  • Onkologische Schwerpunktpraxis Bielefeld
  • Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
  • Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum
  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
  • Diakovere Henriettenstift, Frauenklinik
  • Dres. Andreas Köhler und Roswitha Fuchs
  • St. Elisabeth-Krankenhaus, Senologie/Brustzentrum
  • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
  • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
  • Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH
  • Irccs Ospedale San Raffaele
  • Ospedale San Gerardo
  • Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
  • Aichi Cancer Center Hospital
  • National Hospital Organization Shikoku Cancer Center
  • Fukushima Medical University Hospital
  • Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
  • Kanagawa Cancer Center
  • Tokai University Hospital
  • National Hospital Organization Osaka National Hospital; Breast Surgery
  • St. Luke's Internat. Hospital, Breast Surgical Oncology
  • The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
  • National Cancer Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
  • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • VETERANS GENERAL HOSPITAL; Department of General Surgery
  • Mackay Memorial Hospital; Dept of Surgery
  • Chang Gung Medical Foundation Linkou Branch
  • Leicester Royal Infirmary
  • Barts & London School of Med; Medical Oncology
  • Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atezolizumab and Chemotherapy

Placebo and Chemotherapy

Arm Description

Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.

Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will be unblinded post-surgery and will continue to be followed.

Outcomes

Primary Outcome Measures

Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell [IC] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.

Secondary Outcome Measures

Event-Free Survival (EFS) in All Participants
Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.
Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status
Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.
Disease-Free Survival (DFS) in All Participants Who Undergo Surgery
Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants.
Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery
Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status.
Overall Survival (OS) in All Participants
Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants.
Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status
Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status.
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).
Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30).
Percentage of Participants With at Least One Adverse Events (AEs)
Percentage of participants with at least one adverse event.
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Minimum observed serum atezolizumab concentration.
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Maximum observed atezolizumab concentration (Cmax).
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab.

Full Information

First Posted
June 21, 2017
Last Updated
October 17, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03197935
Brief Title
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
Acronym
IMpassion031
Official Title
A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab and Chemotherapy
Arm Type
Experimental
Arm Description
Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Arm Title
Placebo and Chemotherapy
Arm Type
Placebo Comparator
Arm Description
Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will be unblinded post-surgery and will continue to be followed.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Intervention Description
Atezolizumab was administered as per schedule described in respective arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to atezolizumab was administered as per schedule described in respective arm.
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Nab-paclitaxel was administered as per schedule described in the arms.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin was administered as per schedule described in the arms.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide was administered as per schedule described in the arms.
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Intervention Description
Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Intervention Description
Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population
Description
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Time Frame
After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020
Title
Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System
Description
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell [IC] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Time Frame
After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020
Secondary Outcome Measure Information:
Title
Event-Free Survival (EFS) in All Participants
Description
Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.
Time Frame
From randomization and up to study final analysis data cut off on 28 September 2022.
Title
Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status
Description
Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.
Time Frame
From randomization and up to study final analysis data cut off on 28 September 2022.
Title
Disease-Free Survival (DFS) in All Participants Who Undergo Surgery
Description
Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants.
Time Frame
From surgery and up to study final analysis data cut off on 28 September 2022.
Title
Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery
Description
Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status.
Time Frame
From surgery and up to study final analysis data cut off on 28 September 2022.
Title
Overall Survival (OS) in All Participants
Description
Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants.
Time Frame
From randomization and up to study final analysis data cut off on 28 September 2022.
Title
Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status
Description
Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status.
Time Frame
From randomization and up to study final analysis data cut off on 28 September 2022.
Title
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Description
Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).
Time Frame
From randomization and up to study final analysis data cut off on 28 September 2022.
Title
Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Description
Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30).
Time Frame
From randomization and up to study final analysis data cut off on 28 September 2022.
Title
Percentage of Participants With at Least One Adverse Events (AEs)
Description
Percentage of participants with at least one adverse event.
Time Frame
From randomization and up to study final analysis data cut off on 28 September 2022.
Title
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Description
Minimum observed serum atezolizumab concentration.
Time Frame
Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16)
Title
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Description
Maximum observed atezolizumab concentration (Cmax).
Time Frame
Day 1 of Cycle 1 post dose (cycle length = 28 days)
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Description
Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab.
Time Frame
Baseline up to approximately 20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Histologically documented TNBC (negative human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PgR] status) Confirmed tumor programmed death-ligand 1 (PD-L1) evaluation as documented through central testing of a representative tumor tissue specimen Primary breast tumor size of greater than (>) 2 centimeters (cm) by at least one radiographic or clinical measurement Stage at presentation: cT2-cT4, cN0-cN3, cM0 Participant agreement to undergo appropriate surgical management including axillary lymph node surgery and partial or total mastectomy after completion of neoadjuvant treatment Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans Adequate hematologic and end-organ function Representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PgR, and HER2 negativity For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study drug Exclusion criteria: Prior history of invasive breast cancer Stage 4 (metastatic) breast cancer Prior systemic therapy for treatment and prevention of breast cancer Previous therapy with anthracyclines or taxanes for any malignancy History of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy >5 years prior to diagnosis of current breast cancer History of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed >5 years prior to diagnosis of current breast cancer Bilateral breast cancer Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes 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 with a negligible risk of metastasis or death Cardiopulmonary dysfunction History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells Known allergy or hypersensitivity to the components of the formulations of atezolizumab, nab-paclitaxel, cyclophosphamide, or doxorubicin, filgrastim or pegfilgrastim Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus, and dermatologic manifestations of eczema, psoriasis, lichen simplex chronicus, or vitiligo (e.g., participants with psoriatic arthritis are excluded) History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted Positive human immunodeficiency virus (HIV) test at screening Active hepatitis B and hepatitis C virus infection Active tuberculosis Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, except prophylactic antibiotics Major surgical procedure within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study Prior allogeneic stem cell or solid organ transplantation Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint-blockade therapies, including anti-cluster of differentiation 40 (anti-CD40), anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medications during the study History of cerebrovascular accident within 12 months prior to randomization Pregnant or lactating, or intending to become pregnant during the study
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
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
City
Carrollton
State/Province
Georgia
ZIP/Postal Code
30117
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
HCA Midwest Division
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
The Valley Hospital; Valley Medical Group
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt Breast Center at One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
The Center for Cancer and Blood Disorders - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
City
Bull Creek
State/Province
Western Australia
ZIP/Postal Code
6149
Country
Australia
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Clinique Ste-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Sint Augustinus Wilrijk
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Santa Casa de Misericordia de Salvador
City
Salvador
State/Province
BA
ZIP/Postal Code
40050-410
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
CETUS Hospital Dia Oncologia
City
Uberaba
State/Province
MG
ZIP/Postal Code
38082-049
Country
Brazil
Facility Name
Iop Instituto de Oncologia Do Parana
City
Curitiba
State/Province
PR
ZIP/Postal Code
80530-010
Country
Brazil
Facility Name
Clinicas Oncologicas Integradas - COI
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
22290-160
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
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-001
Country
Brazil
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hopital Sacre-Coeur Research Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hopital du Saint Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Hochwaldkrankenhaus
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
City
Berlin
ZIP/Postal Code
13581
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Bielefeld
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
City
Düsseldorf
ZIP/Postal Code
40235
Country
Germany
Facility Name
Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum
City
Gelsenkirchen
ZIP/Postal Code
45879
Country
Germany
Facility Name
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Facility Name
Diakovere Henriettenstift, Frauenklinik
City
Hannover
ZIP/Postal Code
30559
Country
Germany
Facility Name
Dres. Andreas Köhler und Roswitha Fuchs
City
Langen
ZIP/Postal Code
63225
Country
Germany
Facility Name
St. Elisabeth-Krankenhaus, Senologie/Brustzentrum
City
Leipzig
ZIP/Postal Code
04277
Country
Germany
Facility Name
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Irccs Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale San Gerardo
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36100
Country
Italy
Facility Name
Aichi Cancer Center Hospital
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
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; Breast Surgery
City
Hiroshima
ZIP/Postal Code
730-8518
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
National Hospital Organization Osaka National Hospital; Breast Surgery
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
St. Luke's Internat. Hospital, Breast Surgical Oncology
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
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
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii
City
Wroc?aw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
VETERANS GENERAL HOSPITAL; Department of General Surgery
City
Taipei
ZIP/Postal Code
00112
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 Branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Barts & London School of Med; Medical Oncology
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32966830
Citation
Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020 Oct 10;396(10257):1090-1100. doi: 10.1016/S0140-6736(20)31953-X. Epub 2020 Sep 20.
Results Reference
derived
PubMed Identifier
32450725
Citation
Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.
Results Reference
derived

Learn more about this trial

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

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