Triple Negative Breast NeoplasmsPhase 3IMpassion132NCT03371017
A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer
A Phase 3 study testing Atezolizumab, Gemcitabine and Capecitabine in people with Triple Negative Breast Neoplasms, run by Hoffmann-La Roche at 124 sites in 28 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Neoplasms
- What is being tested?
- Atezolizumab, Gemcitabine and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 595 participants
- Where
- 124 sitesin 28 countries
- Study dates
- 11 Jan 2018to 23 Oct 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
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- 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.
- 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
- 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
- -Hypersensitivity to platinum containing compounds or any component of carboplatin or gemcitabine drug formulations in patients selected to receive carboplatin and Gemcitabine
Trial locations and contacts
124 sites in 28 countries.
124 sites in 28 countries
China18 sites
the First Affiliated Hospital of Bengbu Medical College
Anhui, DUMMY_VALUE
Cancer Hospital , Chinese Academy of Medical
Beijing, 100021
Peking University People's Hospital
Beijing, 100044
Beijing Cancer Hospital
Beijing, 100142
Jilin Cancer Hospital
Changchun, 132013
The First Affiliated Hospital, Chongqing Medical University
Chongqing, 400016
Fujian Medical University Union Hospital
Fujian, 350001
Sun Yat-sen Memorial Hospital
Guangzhou, 510000
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, 310016
Zhejiang Cancer Hospital
Hangzhou, 310022
Harbin Medical University Cancer Hospital
Harbin, 150081
The First Affiliated Hospital Of Jinzhou Medical University
Jinzhou, 121001
Jiangsu Province Hospital
Nanjing, 210036
The Affiliated Hospital of Medical College Qingdao University
Qingdao, 266003
Fudan University Shanghai Cancer Center
Shanghai, 200032
Shanxi Province Cancer Hospital
Taiyuan, DUMMY_VALUE
Tianjin Cancer Hospital
Tianjin, 300060
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
Xi'an, 710032
Brazil9 sites
Centro de Oncologia de Santa Catarina LTDA
Chapecó, Santa Catarina, 89812-211
Oncocentro Serviços Medicos E Hospitalares Ltda
Fortaleza, Ceará, 60130-241
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-090
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, 50040-000
Instituto de Pesquisa Grupo NotreDame Intermedica
São Paulo, São Paulo, 01229-010
Hospital Perola Byington
São Paulo, São Paulo, 01317-000
Núcleo de Pesquisa São Camilo
São Paulo, São Paulo, 03102-002
Italy9 sites
Ospedale Antonio Perrino
Brindisi, Apulia, 72100
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo
Candiolo, Piedmont, 10060
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, 50134
Azienda Ospedaliero Universitaria San Martino
Genoa, Liguria, 16132
Ospedale San Raffaele S.r.l.
Milan, Lombardy, 20132
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, 20141
Ospedale San Gerardo
Monza, Lombardy, 20900
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Naples, Campania, 80131
IRCCS Istituto Oncologico Veneto (IOV)
Padova, Veneto, 35128
United Kingdom9 sites
Velindre Cancer Centre
Cardiff, CF14 2TL
University Hospital Coventry
Coventry, CV2 2DX
Western General Hospital
Edinburgh, EH4 2XU
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
Lancaster, LA1 4RP
Barts
London, EC1M6BQ
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT
Christie Hospital NHS Trust
Manchester, M20 4BX
Mount Vernon Cancer Centre
Northwood, HA6 2RN
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
France7 sites
Centre Georges-François Lecler
Dijon, 21034
Centre Leon Berard
Lyon, 69373
Institut Paoli-Calmettes
Marseille, 13009
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
Montpellier, 34298
Centre Eugene Marquis
Rennes, 35042
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
IGR
Villejuif, 94800
Germany7 sites
Universitätsklinikum "Carl Gustav Carus"
Dresden, 01307
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, 45136
Varisano Klinikum Frankfurt Höchst GmbH
Frankfurt, 65929
Universitätsklinikum Halle (Saale)
Halle, 06120
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
Hanover, 30625
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120
Medizinisches Zentrum für Hämatologie und Onkologie
München, 80639
United States6 sites
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers, Florida, 33916
SCRI Oncology Partners
Nashville, Tennessee, 37203
The Valley Hospital
Paramus, New Jersey, 07652
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, 15213
Florida Cancer Specialists & Research Institute
St. Petersburg, Florida, 33705
Russia6 sites
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, 143423
Moscow Clinical Scientific Center
Moscow, Moscow Oblast, 111123
FSBI "National Medical Research Center of Oncology N.N. Blokhin?
Moscow, Moscow Oblast, 115478
Private Healthcare Institution Clinical Hospital RZhD Medicine
Saint Petersburg, Sankt-Peterburg, 195271
City Clinical Oncology Dispensary, SPb SBIH CCOD
Saint Petersburg, Sankt-Peterburg, 198255
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint Petersburg, Sankt-Peterburg, DUMMY_VALUE
Spain6 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital de Cruces
Bilbao, Vizcaya, 48903
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Ramon y Cajal
Madrid, 28034
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010
Hospital Clínico Universitario de Valencia
Valencia, 46010
Turkey (Türkiye)6 sites
Ankara Oncology Hospital
Ankara, 06200
Ege University Medical Faculty
Bornova, ?zm?r, 35100
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030
Medipol University Medical Faculty
Istanbul, 34214
Marmara University Pendik Training and Research Hospital
Istanbul, 34890
Necmettin Erbakan University Meram Medical Faculty
Konya, 42080
Hungary5 sites
Szent Margit Hospital
Budapest, 1032
Orszagos Onkologiai Intezet
Budapest, 1122
Budapesti Uzsoki Utcai Kórház
Budapest, 1145
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
Pécsi Tudományegyetem
Pécs, 7623
South Korea5 sites
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Serbia4 sites
Institute of Oncology and Radiology of Serbia
Belgrade, 11000
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080
Oncology Institute of Vojvodina
Kamenitz, 21204
Clinical Centre Nis, Clinic for Oncology
Niš, 18000
Mexico3 sites
Instituto Nacional de Cancerologia
Distrito Federal, 14080
Centro Medico Dalinde
Mexico City, Mexico CITY (federal District), 06760
CENEIT Oncologicos
Mexico City, 03100
Morocco3 sites
Centre Hospitalier Universitaire Hassan II
Fes, 30000
Centre Hospitalier Universitaire Mohamed VI
Marrakesh, 40000
Clinique specialise Menara
Marrakesh, 40000
South Africa3 sites
Wits Clinical Research
Johannesburg, 2193
Medical Oncology Centre of Rosebank
Johannesburg, 2196
Private Oncology Centre
Pretoria, 0081
Argentina2 sites
Hospital Provincial del Centenario
Rosario, 2000
Instituto de Oncología de Rosario
Rosario, S2000KZE
Chile2 sites
Bradford Hill Centro de Investigaciones Clinicas
Recoleta, 8420383
Clinica Vespucio
Santiago, 8241479
Cuba2 sites
Hospital Hermanos Ameijeiras
La Habana, 10300
Instituto Nacional de Oncología y Radiología (INOR)
La Habana, 10400
Finland2 sites
Helsinki University Central Hospital
Helsinki, 00029
Tampere University Hospital
Tampere, 33520
Poland2 sites
?wi?tokrzyskie Centrum Onkologii
Kielce, 25-734
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
Warsaw, 02-781
Portugal2 sites
Hospital de Santa Maria
Lisbon, 1649-035
Centro Hospitalar do Porto ? Hospital de Santo António
Porto, 4099-001
Bosnia and Herzegovina1 site
Clinical center University of Sarajevo
Sarajevo, 71000
Kazakhstan1 site
Kazakh Scientific Research Institution Of Oncology and Radiology
Almaty, 050022
About this study
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
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).
- Conditions
- Triple Negative Breast Neoplasms
- Being tested
- Atezolizumab, Placebo, Gemcitabine, Capecitabine, Carboplatin
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
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
PlaceboDrug
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
GemcitabineDrug
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
CapecitabineDrug
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
CarboplatinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab | Experimental | Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle Receives: Drug: Atezolizumab; Drug: Gemcitabine; Drug: Capecitabine; Drug: Carboplatin |
| Placebo | Placebo comparator | Participants will receive Placebo on day 1 of each 3-week treatment cycle Receives: Drug: Placebo; Drug: Gemcitabine; Drug: Capecitabine; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) in PD-L1-positive Population
OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day.
Measured: Time from randomization to death (Up to 68 months)
OS in Modified Intent-to-treat (mITT) Population
OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day.
Measured: Time from randomization to death (Up to 68 months)
Secondary outcomes (22)
12-month Survival Rate in PD-L1-positive Population
12-month survival rate was defined as the percentage of participants alive 12 months after randomization. The 12-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to the nearest whole number.
Measured: 12 months
12-month Survival Rate in mITT Population
12-month survival rate was defined as the percentage of participants alive 12 months after randomization. The 12-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.
Measured: 12 months
18-month Survival Rate in PD-L1-positive Population
18-month survival rate was defined as the percentage of participants alive 18 months after randomization. The 18-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.
Measured: 18 months
18-month Survival Rate in mITT Population
18-month survival rate was defined as the percentage of participants alive 18 months after randomization. The 18-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.
Measured: 18 months
Progression-free Survival (PFS) in PD-L1-positive Population
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 millimeters (mm). Data for participants not experiencing PD or death were censored at the last tumour assessment date. If no tumor assessment was performed after randomisation, data were censored at the date of randomisation +1 day.
Measured: Time from randomization to the first occurrence of PD or death (Up to 68 months)
PFS in mITT Population
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Data for participants not experiencing PD or death were censored at the last tumour assessment date. If no tumor assessment was performed after randomisation, data were censored at the date of randomisation +1 day.
Measured: Time from randomization to the first occurrence of PD or death (Up to 68 months)
Objective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population
ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed objective response (OR). OR was defined as either a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.
Measured: Baseline up to end of study (Up to 68 months)
ORR in Response-evaluable Population, Subset of mITT Population
ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.
Measured: Baseline up to end of study (Up to 68 months)
Duration of Objective Response (DoR) in DoR-evaluable Population Subset of PD-L1-positive Population
DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Measured: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
DoR in DoR-evaluable Population Subset of mITT Population
DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Measured: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
Clinical Benefit Rate (CBR) in Response-evaluable Population Subset of PD-L1-positive Population
CBR was defined as the percentage of participants with either an unconfirmed CR or PR or stable disease (SD) that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Percentages have been rounded off to nearest whole number.
Measured: Up to 68 months
CBR in Response-evaluable Population Subset of mITT Population
CBR was defined as the percentage of participants with either an unconfirmed CR or PR or SD that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Percentages have been rounded off to nearest whole number.
Measured: Up to 68 months
Confirmed Objective Response Rate (C-ORR) in Response-evaluable Population Subset of PD-L1-positive Population
C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.
Measured: Up to 68 months
C-ORR in Response-evaluable Population Subset of mITT Population
C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.
Measured: Up to 68 months
DoR for Confirmed Responders (C-DoR) in C-DoR-evaluable Population Subset of PD-L1-positive Population
C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Measured: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
C-DoR in C-DoR-evaluable Population Subset of mITT Population
C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Measured: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
Time to Confirmed Deterioration (TTD) in Global Health Status/Quality of Life (GHS/QoL) According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) in PD-L1-positive Population
TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, \& six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") \& QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed \& were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.
Measured: Up to 68 months
TTD in GHS/QoL According to EORTC QLQ-C30 in mITT Population
TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, \& six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") \& QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed \& were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.
Measured: Up to 68 months
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions that worsen during a study are also considered AEs.
Measured: From treatment initiation up to 90 days after last dose (up to 71 months)
Serum Concentration of Atezolizumab
Measured: Pre-dose on Day 1 of Cycles 1, 2, 3 and 4; Post-dose on Day 1 of Cycles 1 and 3 and Treatment Discontinuation Visit (up to 69 months) (1 Cycle= 3 weeks)
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Number of ADA-positive participants after drug administration was determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. The sum of participants who were ADA-positive at postbaseline visits of Cycles 1 to 4 and treatment discontinuation has been reported here.
Measured: Cycles 1 to 4 and Treatment Discontinuation visit (up to 69 months)
Number of Participants With PD-L1 Protein Expression in Screening Tumour Tissue and Post-baseline Assessment
Measured: Baseline up to 68 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start11 Jan 2018
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371017
- Sponsor's protocol ID
- MO39193
- Other IDs
- 2016-005119-42, 2016
- Acronym
- IMpassion132
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2017
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Dent R, Andre F, Goncalves A, Martin M, Schmid P, Schutz F, Kummel S, Swain SM, Bilici A, Loirat D, Villalobos Valencia R, Im SA, Park YH, De Laurentis M, Colleoni M, Guarneri V, Bianchini G, Li H, Kirchmayer Machackova Z, Mouta J, Deurloo R, Gan X, Fan M, Mani A, Swat A, Cortes J. IMpassion132 double-blind randomised phase III trial of chemotherapy with or without atezolizumab for early relapsing unresectable locally advanced or metastatic triple-negative breast cancer. Ann Oncol. 2024 Jul;35(7):630-642. doi: 10.1016/j.annonc.2024.04.001. Epub 2024 May 15.
PubMed 38755096