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A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer (IMpassion132)

Primary Purpose

Triple Negative Breast Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Placebo
Gemcitabine
Capecitabine
Carboplatin
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 Neoplasms

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed triple negative breast cancer (TNBC) that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
  • Documented disease progression occurring within 12 months from the last treatment with curative intent
  • Prior treatment (of early breast cancer) with an anthracycline and taxane
  • Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. Prior radiation therapy for recurrent disease is permitted
  • Measurable or non-measurable disease, as defined by RECIST 1.1
  • Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumour block (preferred) or at least 17 unstained slides obtained from relapsed metastatic or locally advanced diseases may be submitted, if clinically feasible, with an associated pathology report, if available. If a fresh tumour sample is not clinically feasible, either the diagnosis sample, the primary surgical resection sample, or the most recent FFPE tumour biopsy sample should be used.
  • Eastern Cooperative Oncology Group performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Adequate haematologic and end-organ function
  • Negative human immunodeficiency virus (HIV) test ---Negative hepatitis B surface antigen (HBsAg) test at screening
  • Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
  • The HBV DNA test will be performed only for patients who have a negative HBsAg and a positive HBcAb test.
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening.
  • Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of capecitabine, whichever is later. In addition, women must refrain from donating eggs during the same time period.
  • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm

Inclusion criteria for patients enrolled after the recruitment of all-comers is complete:

-PD-L1-positive tumour status (assessed centrally prior to randomisation), defined as PD-L1 expression on tumour-infiltrating immune cells (IC) of 1% or greater.

Exclusion Criteria:

  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
  • Symptomatic or rapid visceral progression
  • No prior treatment with an anthracycline and taxane
  • History of leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) (patients with indwelling catheters such as PleurX® are allowed)
  • Uncontrolled tumour-related pain
  • Uncontrolled or symptomatic hypercalcemia
  • Malignancies other than TNBC within 5 years prior to randomisation)
  • Significant cardiovascular disease, within 3 months prior to randomisation, unstable arrhythmias, or unstable angina
  • Presence of an abnormal ECG
  • Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
  • Current treatment with anti-viral therapy for HBV.
  • Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis
  • Treatment with investigational therapy within 28 days prior to randomisation
  • Pregnant or lactating, or intending to become pregnant during or within 5 months after the last dose of atezolizumab, or within 6 months after the last dose of capecitabine, whichever is later.

Exclusion Criteria Related to Atezolizumab:

  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation
  • History of autoimmune disease
  • Prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computerised tomography (CT) scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Active tuberculosis
  • Receipt of a live, attenuated vaccine within 4 weeks prior to randomisation or anticipation that a live, attenuated vaccine will be required during atezolizumab/placebo treatment or within 5 months after the last dose of atezolizumab/placebo
  • Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to randomisation
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to start of study treatment, or anticipated requirement for systemic immunosuppressive medications during the trial

Exclusion Criteria Related to Capecitabine:

  • Inability to swallow pills
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to fluoropyrimidine therapy in patients selected to receive capecitabine

Exclusion Criteria Related to Carboplatin/Gemcitabine:

-Hypersensitivity to platinum containing compounds or any component of carboplatin or gemcitabine drug formulations in patients selected to receive carboplatin and Gemcitabine

Sites / Locations

  • Florida Cancer Specialists - Fort Myers (Broadway)
  • Florida Cancer Specialists & Research Institute
  • The Valley Hospital
  • Magee-Woman's Hospital; UPMC Pinnacle Cancer Center
  • Magee-Woman's Hospital
  • Tennessee Oncology; Sarah Cannon Research Institute
  • Inova Schar Cancer Institute
  • Fundación CENIT para la Investigación en Neurociencias
  • Instituto de Oncología de Rosario
  • Hospital Provincial del Centenario
  • University Clinical Center of the Republic of Srpska
  • Clinic of Oncology, University Clinical Center Sarajevo
  • Oncocentro Serviços Medicos E Hospitalares Ltda
  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
  • Hospital do Cancer de Pernambuco - HCP
  • Hospital Sao Vicente de Paulo
  • Hospital Nossa Senhora da Conceicao
  • Centro de Oncologia de Santa Catarina LTDA
  • Instituto de Pesquisa Grupo NotreDame Intermedica
  • Hospital Perola Byington
  • Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
  • Patagonia Research
  • Bradford Hill Centro de Investigaciones Clinicas
  • Fundacion Arturo Lopez Perez
  • Clinica Vespucio
  • James Lind Centro de Investigación Del Cáncer
  • ONCOCENTRO APYS; Oncología
  • Cancer Hospital , Chinese Academy of Medical
  • Peking University People's Hospital
  • Beijing Cancer Hospital
  • the First Affiliated Hospital of Bengbu Medical College
  • Jilin Cancer Hospital
  • Hunan Cancer Hospital
  • The First Affiliated Hospital, Chongqing Medical University
  • Fujian Medical University Union Hospital
  • Sun Yet-sen University Cancer Center
  • Sun Yat-sen Memorial Hospital
  • Sir Run Run Shaw Hospital Zhejiang University
  • Harbin Medical University Cancer Hospital
  • Shandong Cancer Hospital
  • The First Affiliated Hospital Of Jinzhou Medical University
  • Jiangsu Province Hospital
  • The Affiliated Hospital of Medical College Qingdao University
  • Fudan University Shanghai Cancer Center; Medical Oncology
  • First Hospital of China Medical University
  • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
  • Shanxi Province Cancer Hospital
  • Tianjin Cancer Hospital
  • The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
  • Zhejiang Cancer Hospital
  • Hospital Hermanos Ameijeiras
  • Instituto Nacional de Oncología y Radiología (INOR)
  • Helsinki University Central Hospital; Dept of Oncology
  • Tampere University Hospital; Dept of Oncology
  • Centre Georges-François Lecler; Ctr de Lutte Contre le Canc
  • Centre Leon Berard; Oncologie Genetique
  • Institut Paoli-Calmettes; Oncologie Medicale 1
  • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
  • INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.
  • Centre Eugene Marquis; Service d'oncologie
  • Centre Alexis Vautrin; Oncologie Medicale
  • IGR
  • Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
  • Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe
  • Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
  • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
  • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
  • Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer
  • Szent Margit Hospital
  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  • Budapesti Uzsoki Utcai Kórház
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez
  • Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
  • Azienda Ospedaliero Universitaria San Martino
  • Ospedale San Raffaele S.r.l.
  • Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
  • Ospedale San Gerardo
  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
  • Ospedale Antonio Perrino; Oncologia Medica
  • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
  • Kazakh Scientific Research Institution Of Oncology and Radiology
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Centro Medico Dalinde
  • CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
  • Instituto Nacional de Cancerologia; Oncology
  • Clinical Center of Montenegro; Clinic for Oncology and Radiotherapy
  • Centre Hospitalier Universitaire Hassan II
  • Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
  • Clinique specialise Menara; Oncology Medical
  • Institut National D'oncologie Sidi Med Benabdellah
  • The Panama Clinic
  • Instituto Nacional de Enfermedades Neoplasicas
  • ?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii
  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
  • Hospital de Santa Maria; Servico de Oncologia Medica
  • Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
  • IPO do Porto; Servico de Oncologia Medica
  • Moscow City Oncology Hospital #62
  • Moscow Clinical Scientific Center
  • FSBI "National Medical Research Center of Oncology N.N. Blokhin?
  • City Clinical Oncology Dispensary, SPb SBIH CCOD
  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
  • Private Healthcare Institution Clinical Hospital RZhD Medicine
  • Institute of Oncology and Radiology of Serbia
  • University Hospital Medical Center Bezanijska kosa
  • Clinical Centre Nis, Clinic for Oncology
  • Oncology Institute of Vojvodina
  • National Cancer Centre; Medical Oncology
  • Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital
  • Medical Oncology Centre of Rosebank; Oncology
  • Private Oncology Centre
  • Hospital de Cruces; Servicio de Oncologia
  • Hospital Universitari Vall d'Hebron; Oncology
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital Clínico Universitario de Valencia; Servicio de Oncología
  • Hacettepe University Medical Faculty; Department of Internal Medicine
  • Ankara Oncology Hospital; Medical Oncology Department
  • Ege University Medical Faculty; Medical Oncology Department
  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Medipol University Medical Faculty; Oncology Department
  • Marmara University Pendik Training and Research Hospital; Medikal Onkoloji
  • Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
  • Velindre Cancer Centre; Oncology Dept
  • University Hospital Coventry
  • Western General Hospital; Edinburgh Cancer Center
  • Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
  • Barts
  • Guys and St Thomas NHS Foundation Trust, Guys Hospital
  • Christie Hospital NHS Trust
  • Mount Vernon Cancer Centre
  • Royal Stoke University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atezolizumab

Placebo

Arm Description

Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle

Participants will receive Placebo on day 1 of each 3-week treatment cycle

Outcomes

Primary Outcome Measures

Overall Survival (OS) in Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
OS will be tested hierarchically in the following fixed order: In the population with programmed deathligand 1 (PD-L1)-positive tumour status In the modified intent-to-treat (mITT) population
Overall Survival (OS) in Modified Intent-To-Treat (mITT) Popluation
OS will be tested hierarchically in the following fixed order: In the population with programmed deathligand 1 (PD-L1)-positive tumour status In the modified intent-to-treat (mITT) population

Secondary Outcome Measures

Proportion of Participants Alive 12 Months
Proportion of Participants Alive 18 Months
Progression-Free Survival (PFS) in Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death from any cause, whichever occurs first. PFS will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Progression-Free Survival (PFS) in mITT population
PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death from any cause, whichever occurs first. PFS will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Objective Response Rate (ORR) in Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
ORR defined as the proportion of patients with an objective response, defined as a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST 1.1. ORR will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Objective Response Rate (ORR) in Modified Intent-To-Treat (mITT) Popluation
ORR defined as the proportion of patients with an objective response, defined as a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST 1.1. ORR will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Duration of Objective Response (DoR)
DoR as determined by the investigator according to RECIST 1.1.
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants with a CR or a PR or stable disease as determined by the investigator according to RECIST 1.1.
Confirmed Objective Response Rate (C-ORR)
Duration of Response for Confirmed Responders (C-DoR)
Time to Confirmed Deterioration (TTD) of GHS/QoL
TTD of GHS/QoL, defined by a minimally important decrease of ≥10 points at two consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of the EORTC QLQ-C30.
Percentage of Participants With Adverse Events
Maximum Serum Concentration (Cmax) of Atezolizumab
Minimum Serum Concentration (Cmin) of Atezolizumab
Incidence of Anti-Drug Antibodies (ADAs) to Atezolizumab
Relationship Between PD-L1 Protein Expression in Screening Tumour Tissue and Clinical Outcomes
Overall Survival (OS) in China Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
OS will be tested hierarchically in the following fixed order: In the population with programmed deathligand 1 (PD-L1)-positive tumour status In the modified intent-to-treat (mITT) population
Overall Survival (OS) in mITT China Popluation
OS will be tested hierarchically in the following fixed order: In the population with programmed deathligand 1 (PD-L1)-positive tumour status In the modified intent-to-treat (mITT) population
Proportion of Participants Alive 12 Months in China Population
Proportion of Participants Alive 18 Months in China Population
Progression Free Survival (PFS) in China Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death from any cause, whichever occurs first. PFS will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Progression Free Survival (PFS) in mITT China Population
PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death from any cause, whichever occurs first. PFS will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Objective Response Rate (ORR) in China Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
ORR defined as the proportion of patients with an objective response, defined as a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST 1.1. ORR will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
ORR in Modified Intent-To-Treat (mITT) China Popluation
ORR defined as the proportion of patients with an objective response, defined as a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST 1.1. ORR will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Duration of Objective Response (DoR) in China Population
DoR as determined by the investigator according to RECIST 1.1.
Clinical Benefit Rate (CBR) in China Population
CBR is defined as the proportion of participants with a CR or a PR or stable disease as determined by the investigator according to RECIST 1.1.
Confirmed Objective Response Rate (C-ORR) in China Population
Duration of Response for Confirmed Responders (C-DoR) in China Population
Time to Confirmed Deterioration (TTD) of GHS/QoL in China Population
TTD of GHS/QoL, defined by a minimally important decrease of ≥10 points at two consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of the EORTC QLQ-C30.

Full Information

First Posted
November 21, 2017
Last Updated
August 14, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03371017
Brief Title
A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer
Acronym
IMpassion132
Official Title
A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

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 study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent 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 Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
572 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab
Arm Type
Experimental
Arm Description
Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive Placebo on day 1 of each 3-week treatment cycle
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Atezolizumab will be administered, 1200 mg by IV infusion with : gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered, 1200 mg by IV infusion with : gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle
Primary Outcome Measure Information:
Title
Overall Survival (OS) in Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
Description
OS will be tested hierarchically in the following fixed order: In the population with programmed deathligand 1 (PD-L1)-positive tumour status In the modified intent-to-treat (mITT) population
Time Frame
Baseline to end of study (approximately 58 months)
Title
Overall Survival (OS) in Modified Intent-To-Treat (mITT) Popluation
Description
OS will be tested hierarchically in the following fixed order: In the population with programmed deathligand 1 (PD-L1)-positive tumour status In the modified intent-to-treat (mITT) population
Time Frame
Baseline to end of study (approximately 58 months)
Secondary Outcome Measure Information:
Title
Proportion of Participants Alive 12 Months
Time Frame
Randomization to 12 months post randomization
Title
Proportion of Participants Alive 18 Months
Time Frame
Randomization to 18 months post randomization
Title
Progression-Free Survival (PFS) in Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
Description
PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death from any cause, whichever occurs first. PFS will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Time Frame
Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 58 months)
Title
Progression-Free Survival (PFS) in mITT population
Description
PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death from any cause, whichever occurs first. PFS will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Time Frame
Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 58 months)
Title
Objective Response Rate (ORR) in Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
Description
ORR defined as the proportion of patients with an objective response, defined as a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST 1.1. ORR will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Time Frame
Baseline; every 8 weeks for the first 12 months after randomisation, and every 12 weeks thereafter until disease progression, withdrawal of consent, death, or study termination (approximately 58 months)
Title
Objective Response Rate (ORR) in Modified Intent-To-Treat (mITT) Popluation
Description
ORR defined as the proportion of patients with an objective response, defined as a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST 1.1. ORR will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Time Frame
Baseline; every 8 weeks for the first 12 months after randomisation, and every 12 weeks thereafter until disease progression, withdrawal of consent, death, or study termination (approximately 58 months)
Title
Duration of Objective Response (DoR)
Description
DoR as determined by the investigator according to RECIST 1.1.
Time Frame
Time from the first occurrence of a documented objective response to disease progression or death (through the end of study, approximately 58 months)
Title
Clinical Benefit Rate (CBR)
Description
CBR is defined as the proportion of participants with a CR or a PR or stable disease as determined by the investigator according to RECIST 1.1.
Time Frame
8 weeks for the first 12 months after treatment initiation and every 12 weeks thereafter until disease progression (through the end of study, approximately 58 months)
Title
Confirmed Objective Response Rate (C-ORR)
Time Frame
Baseline; every 8 weeks for the first 12 months after randomisation, and every 12 weeks thereafter until disease progression, withdrawal of consent, death, or study termination (approximately 58 months)
Title
Duration of Response for Confirmed Responders (C-DoR)
Time Frame
Time from the first occurrence of a documented objective response to disease progression or death (through the end of study, approximately 58 months)
Title
Time to Confirmed Deterioration (TTD) of GHS/QoL
Description
TTD of GHS/QoL, defined by a minimally important decrease of ≥10 points at two consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of the EORTC QLQ-C30.
Time Frame
Baseline to end of study (approximately 58 months)
Title
Percentage of Participants With Adverse Events
Time Frame
Baseline to end of study (approximately 58 months)
Title
Maximum Serum Concentration (Cmax) of Atezolizumab
Time Frame
At pre-defined intervals from Day 1, Cycle 1 through Cycle 4 (cycle = 21 days)
Title
Minimum Serum Concentration (Cmin) of Atezolizumab
Time Frame
At pre-defined intervals from Day 1, Cycle 1 through Cycle 4 (cycle = 21 days)
Title
Incidence of Anti-Drug Antibodies (ADAs) to Atezolizumab
Time Frame
Baseline to end of study (approximately 58 months)
Title
Relationship Between PD-L1 Protein Expression in Screening Tumour Tissue and Clinical Outcomes
Time Frame
Baseline to end of study (approximately 58 months)
Title
Overall Survival (OS) in China Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
Description
OS will be tested hierarchically in the following fixed order: In the population with programmed deathligand 1 (PD-L1)-positive tumour status In the modified intent-to-treat (mITT) population
Time Frame
Baseline to end of study (approximately 58 months)
Title
Overall Survival (OS) in mITT China Popluation
Description
OS will be tested hierarchically in the following fixed order: In the population with programmed deathligand 1 (PD-L1)-positive tumour status In the modified intent-to-treat (mITT) population
Time Frame
Baseline to end of study (approximately 58 months)
Title
Proportion of Participants Alive 12 Months in China Population
Time Frame
Randomization to 12 months post randomization
Title
Proportion of Participants Alive 18 Months in China Population
Time Frame
Randomization to 18 months post randomization
Title
Progression Free Survival (PFS) in China Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
Description
PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death from any cause, whichever occurs first. PFS will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Time Frame
Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 58 months)
Title
Progression Free Survival (PFS) in mITT China Population
Description
PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death from any cause, whichever occurs first. PFS will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Time Frame
Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 58 months)
Title
Objective Response Rate (ORR) in China Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
Description
ORR defined as the proportion of patients with an objective response, defined as a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST 1.1. ORR will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Time Frame
Baseline; every 8 weeks for the first 12 months after randomisation, and every 12 weeks thereafter until disease progression, withdrawal of consent, death, or study termination (approximately 58 months)
Title
ORR in Modified Intent-To-Treat (mITT) China Popluation
Description
ORR defined as the proportion of patients with an objective response, defined as a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST 1.1. ORR will be tested hierarchically in the following fixed order: In the PD-L1-positive population In the mITT population
Time Frame
Baseline; every 8 weeks for the first 12 months after randomisation, and every 12 weeks thereafter until disease progression, withdrawal of consent, death, or study termination (approximately 58 months)
Title
Duration of Objective Response (DoR) in China Population
Description
DoR as determined by the investigator according to RECIST 1.1.
Time Frame
Time from the first occurrence of a documented objective response to disease progression or death (through the end of study, approximately 58 months)
Title
Clinical Benefit Rate (CBR) in China Population
Description
CBR is defined as the proportion of participants with a CR or a PR or stable disease as determined by the investigator according to RECIST 1.1.
Time Frame
8 weeks for the first 12 months after treatment initiation and every 12 weeks thereafter until disease progression (through the end of study, approximately 58 months)
Title
Confirmed Objective Response Rate (C-ORR) in China Population
Time Frame
Baseline; every 8 weeks for the first 12 months after randomisation, and every 12 weeks thereafter until disease progression, withdrawal of consent, death, or study termination (approximately 58 months)
Title
Duration of Response for Confirmed Responders (C-DoR) in China Population
Time Frame
Time from the first occurrence of a documented objective response to disease progression or death (through the end of study, approximately 58 months)
Title
Time to Confirmed Deterioration (TTD) of GHS/QoL in China Population
Description
TTD of GHS/QoL, defined by a minimally important decrease of ≥10 points at two consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of the EORTC QLQ-C30.
Time Frame
Baseline to end of study (approximately 58 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed triple negative breast cancer (TNBC) that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic Documented disease progression occurring within 12 months from the last treatment with curative intent Prior treatment (of early breast cancer) with an anthracycline and taxane Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. Prior radiation therapy for recurrent disease is permitted Measurable or non-measurable disease, as defined by RECIST 1.1 Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumour block (preferred) or at least 17 unstained slides obtained from relapsed metastatic or locally advanced diseases may be submitted, if clinically feasible, with an associated pathology report, if available. If a fresh tumour sample is not clinically feasible, either the diagnosis sample, the primary surgical resection sample, or the most recent FFPE tumour biopsy sample should be used. Eastern Cooperative Oncology Group performance status 0-1 Life expectancy ≥ 12 weeks Adequate haematologic and end-organ function Negative human immunodeficiency virus (HIV) test ---Negative hepatitis B surface antigen (HBsAg) test at screening Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening The HBV DNA test will be performed only for patients who have a negative HBsAg and a positive HBcAb test. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of capecitabine, whichever is later. In addition, women must refrain from donating eggs during the same time period. Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm Inclusion criteria for patients enrolled after the recruitment of all-comers is complete: -PD-L1-positive tumour status (assessed centrally prior to randomisation), defined as PD-L1 expression on tumour-infiltrating immune cells (IC) of 1% or greater. Exclusion Criteria: Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Symptomatic or rapid visceral progression No prior treatment with an anthracycline and taxane History of leptomeningeal disease Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) (patients with indwelling catheters such as PleurX® are allowed) Uncontrolled tumour-related pain Uncontrolled or symptomatic hypercalcemia Malignancies other than TNBC within 5 years prior to randomisation) Significant cardiovascular disease, within 3 months prior to randomisation, unstable arrhythmias, or unstable angina Presence of an abnormal ECG Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia. Current treatment with anti-viral therapy for HBV. Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis Treatment with investigational therapy within 28 days prior to randomisation Pregnant or lactating, or intending to become pregnant during or within 5 months after the last dose of atezolizumab, or within 6 months after the last dose of capecitabine, whichever is later. Exclusion Criteria Related to Atezolizumab: History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation History of autoimmune disease Prior allogeneic stem cell or solid organ transplantation History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computerised tomography (CT) scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted. Active tuberculosis Receipt of a live, attenuated vaccine within 4 weeks prior to randomisation or anticipation that a live, attenuated vaccine will be required during atezolizumab/placebo treatment or within 5 months after the last dose of atezolizumab/placebo Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to randomisation Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to start of study treatment, or anticipated requirement for systemic immunosuppressive medications during the trial Exclusion Criteria Related to Capecitabine: Inability to swallow pills Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis Known dihydropyrimidine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to fluoropyrimidine therapy in patients selected to receive capecitabine Exclusion Criteria Related to Carboplatin/Gemcitabine: -Hypersensitivity to platinum containing compounds or any component of carboplatin or gemcitabine drug formulations in patients selected to receive carboplatin and Gemcitabine
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
Florida Cancer Specialists - Fort Myers (Broadway)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
The Valley Hospital
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Magee-Woman's Hospital; UPMC Pinnacle Cancer Center
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Facility Name
Magee-Woman's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Tennessee Oncology; Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Inova Schar Cancer Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Instituto de Oncología de Rosario
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Hospital Provincial del Centenario
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
University Clinical Center of the Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinic of Oncology, University Clinical Center Sarajevo
City
Sarajevo
ZIP/Postal Code
7100
Country
Bosnia and Herzegovina
Facility Name
Oncocentro Serviços Medicos E Hospitalares Ltda
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60135-237
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 do Cancer de Pernambuco - HCP
City
Recife
State/Province
PE
ZIP/Postal Code
50040-000
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-090
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Centro de Oncologia de Santa Catarina LTDA
City
Chapeco
State/Province
SC
ZIP/Postal Code
89812-211
Country
Brazil
Facility Name
Instituto de Pesquisa Grupo NotreDame Intermedica
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01229-010
Country
Brazil
Facility Name
Hospital Perola Byington
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
Patagonia Research
City
Puerto Montt
ZIP/Postal Code
5480000
Country
Chile
Facility Name
Bradford Hill Centro de Investigaciones Clinicas
City
Recoleta
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Clinica Vespucio
City
Santiago
ZIP/Postal Code
8241479
Country
Chile
Facility Name
James Lind Centro de Investigación Del Cáncer
City
Temuco
ZIP/Postal Code
4800827
Country
Chile
Facility Name
ONCOCENTRO APYS; Oncología
City
Vina Del Mar
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Cancer Hospital , Chinese Academy of Medical
City
Beijing City
ZIP/Postal Code
100021
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
the First Affiliated Hospital of Bengbu Medical College
City
Bengbu City
ZIP/Postal Code
233000
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha CITY
ZIP/Postal Code
410013
Country
China
Facility Name
The First Affiliated Hospital, Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou City
ZIP/Postal Code
350001
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University
City
Hangzhou City
ZIP/Postal Code
310016
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Facility Name
The First Affiliated Hospital Of Jinzhou Medical University
City
Jinzhou City
ZIP/Postal Code
121001
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
The Affiliated Hospital of Medical College Qingdao University
City
Qingdao
ZIP/Postal Code
266003
Country
China
Facility Name
Fudan University Shanghai Cancer Center; Medical Oncology
City
Shanghai City
ZIP/Postal Code
201315
Country
China
Facility Name
First Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
City
Shijiazhuang
ZIP/Postal Code
050035
Country
China
Facility Name
Shanxi Province Cancer Hospital
City
Taiyuan City
ZIP/Postal Code
030013
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
City
Xi'an
ZIP/Postal Code
710032
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Hospital Hermanos Ameijeiras
City
La Habana
ZIP/Postal Code
10300
Country
Cuba
Facility Name
Instituto Nacional de Oncología y Radiología (INOR)
City
La Habana
ZIP/Postal Code
10400
Country
Cuba
Facility Name
Helsinki University Central Hospital; Dept of Oncology
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Facility Name
Tampere University Hospital; Dept of Oncology
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Centre Georges-François Lecler; Ctr de Lutte Contre le Canc
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre Leon Berard; Oncologie Genetique
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli-Calmettes; Oncologie Medicale 1
City
Marseille Cedex 09
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Centre Eugene Marquis; Service d'oncologie
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Alexis Vautrin; Oncologie Medicale
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54519
Country
France
Facility Name
IGR
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer
City
München
ZIP/Postal Code
80638
Country
Germany
Facility Name
Szent Margit Hospital
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Budapesti Uzsoki Utcai Kórház
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale San Raffaele S.r.l.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Ospedale San Gerardo
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
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
Ospedale Antonio Perrino; Oncologia Medica
City
Brindisi
State/Province
Puglia
ZIP/Postal Code
72100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Kazakh Scientific Research Institution Of Oncology and Radiology
City
Almaty
ZIP/Postal Code
050022
Country
Kazakhstan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
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
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Centro Medico Dalinde
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06760
Country
Mexico
Facility Name
CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Instituto Nacional de Cancerologia; Oncology
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Clinical Center of Montenegro; Clinic for Oncology and Radiotherapy
City
Podgorica
ZIP/Postal Code
81000
Country
Montenegro
Facility Name
Centre Hospitalier Universitaire Hassan II
City
FES
ZIP/Postal Code
30000
Country
Morocco
Facility Name
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
City
Marrakech
ZIP/Postal Code
40000
Country
Morocco
Facility Name
Clinique specialise Menara; Oncology Medical
City
Marrakech
ZIP/Postal Code
40000
Country
Morocco
Facility Name
Institut National D'oncologie Sidi Med Benabdellah
City
Rabat
ZIP/Postal Code
6213
Country
Morocco
Facility Name
The Panama Clinic
City
Panama
ZIP/Postal Code
0832-02723
Country
Panama
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Facility Name
?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii
City
Kielce
ZIP/Postal Code
25-734
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
Hospital de Santa Maria; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Moscow Clinical Scientific Center
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
FSBI "National Medical Research Center of Oncology N.N. Blokhin?
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
City Clinical Oncology Dispensary, SPb SBIH CCOD
City
Saint-Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
City
Saint-Petersburg
State/Province
Sankt Petersburg
Country
Russian Federation
Facility Name
Private Healthcare Institution Clinical Hospital RZhD Medicine
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Institute of Oncology and Radiology of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Hospital Medical Center Bezanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Centre Nis, Clinic for Oncology
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Oncology Institute of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Facility Name
Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Medical Oncology Centre of Rosebank; Oncology
City
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Private Oncology Centre
City
Pretoria
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Hospital de Cruces; Servicio de Oncologia
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia; Servicio de Oncología
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hacettepe University Medical Faculty; Department of Internal Medicine
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Oncology Hospital; Medical Oncology Department
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Ege University Medical Faculty; Medical Oncology Department
City
Bornova, ?zm?r
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Medipol University Medical Faculty; Oncology Department
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Marmara University Pendik Training and Research Hospital; Medikal Onkoloji
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Velindre Cancer Centre; Oncology Dept
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Western General Hospital; Edinburgh Cancer Center
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Barts
City
London
ZIP/Postal Code
EC1M6BQ
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust, Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer

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