Triple-Negative Breast CancerPhase 3IMpassion131NCT03125902
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody and Paclitaxel in people with Triple-Negative Breast Cancer, run by Hoffmann-La Roche at 161 sites in 24 countries.
Trial summary
This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple-Negative Breast Cancer
- What is being tested?
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 653 participants
- Where
- 161 sitesin 24 countries
- Study dates
- 25 Aug 2017to 17 Jan 2023
- 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
- Participants with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PR] expression), not amenable to surgical therapy
- Participants eligible for taxane monotherapy
- No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor block (preferred) or at least 17 unstained slides, collected ≤3 months prior to randomization, with an associated pathology report, if available. If a tumour sample taken within 3 months before randomisation is not available and a tumour biopsy is not clinically feasible, the primary surgical resection sample or the most recent FFPE tumour biopsy sample may be used. Of these additional options, the most recent sample should be used.
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy at least 12 weeks
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- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end-organ function
- Negative human immunodeficiency virus (HIV) test at screening.
- 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 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. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
- Women of child bearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
- For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 5 months after the last dose of atezolizumab/placebo, or for at least 6 months after the last dose of paclitaxel
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 at least 2 weeks prior to randomization
- Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Uncontrolled tumor-related pain, or uncontrolled hypercalcemia or clinically significant (symptomatic) hypercalcemia
- Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)
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- Pregnant or breast-feeding women, or intending to become pregnant during the study
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease, cardiovascular disease, and presence of an abnormal electrocardiogram (ECG)
- Serious infection requiring antibiotics within 2 weeks prior to randomization, including but not limited to infections requiring hospitalization or IV antibiotics, such as bacteremia, or severe pneumonia
- Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis
- Treatment with investigational therapy within 30 days prior to initiation of study treatment
- History of hypersensitivity reactions to study drug or any component of the study drug formulation
Trial locations and contacts
161 sites in 24 countries.
161 sites in 24 countries
Italy20 sites
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Lombardy, 24127
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, 25123
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
Candiolo, Piedmont, 10060
Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)
Chieti, Abruzzo, 66103
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
Florence, Tuscany, 50134
Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia
Frattamaggiore, Campania, 80027
A.O. Universitaria S. Martino Di Genova
Genoa, Liguria, 16132
Ospedale Civile; Unita Operativa Di Oncologia Medica
Livorno, Tuscany, 57100
Hospital San Raffaele
Milan, Lombardy, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica
Milan, Lombardy, 20141
Azienda Ospedaliero - Universitaria di Modena Policlinico
Modena, Emilia-Romagna, 41110
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, 80131
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Campania, 80131
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova, Veneto, 35128
Universita Campus Bio-Medico di Roma (UCBM)
Rome, Lazio, 00128
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
Rome, Lazio, 00144
Azienda Policlinico Umberto I
Rome, Lazio, 00161
IRCCS Istituto Clinico Humanitas; Oncologia
Rozzano (MI), Lombardy, 20089
Ospedale S. Vincenzo; Oncologia Medica
Taormina, Sicily, 98030
China17 sites
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021
Beijing Union Hospital
Beijing, 100730
West China Hospital, Sichuan University; Department of Breast
Chengdu, 610041
Sun Yat-sen Memorial Hospital
Guangzhou, 510000
Harbin Medical University Cancer Hospital
Harbin, 150081
Shandong Cancer Hospital
Jinan, 250117
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, 210029
Jiangsu Cancer Hospital
Nanjing, 211100
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, 200025
Fudan University Shanghai Cancer Center
Shanghai, 200120
Liaoning cancer Hospital & Institute
Shenyang, 110042
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, 050035
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 3000060
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, 710004
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061
Zhejiang Cancer Hospital
Zhejiang, 310022
Henan Cancer Hospital
Zhengzhou, 450008
France17 sites
Clinique Sainte Catherine; Hopital De Semaine
Avignon, 84918
HOPITAL JEAN MINJOZ; Oncologie
Besançon, 25030
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
Hopital Morvan
Brest, 29200
CHD Les Oudairies
La Roche-sur-Yon, 85925
Centre Oscar Lambret; Senologie
Lille, 59020
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373
Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100
Hopital Caremeau; Hematologie Oncologie
Nîmes, 30029
Hopital Tenon
Paris, 75020
Institut Curie; Oncologie Medicale
Paris, 75231
Hopital Saint Louis, Service D Oncologie Medicale
Paris, 75475
Ch Pitie Salpetriere; Oncologie Medicale
Paris, 75651
Centre Eugene Marquis; Service d'oncologie
Rennes, 35042
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059
Institut Gustave Roussy; Sitep
Villejuif, 94805
Germany13 sites
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
Berlin, 13581
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, 33604
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Cologne, 50935
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, 45136
HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg
Hamburg, 22767
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, 69120
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, 55131
OnkoNet Marburg GmbH
Marburg, 35037
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, 80336
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48153
Klinikum Ernst von Bergmann; Frauenklinik
Potsdam, 14467
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
Troisdorf, 53840
Universitätsklinik Tübingen; Frauenklinik
Tübingen, 72076
India12 sites
Manipal Hospital; Department of Oncology
Bangalore, Karnataka, 560017
Apollo Speciality Hospital
Chennai, Tamil Nadu, 600035
MAX Balaji Hospital
Delhi, 1100092
Yashoda Hospital
Hyderabad, Andhra Pradesh, 500082
Apollo Gleneagles Hospitals
Kolkata, West Bengal, 700054
TATA Medical Centre; Medical Oncology
Kolkata, West Bengal, 700156
Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, 400012
Dr. B L Kapur Memorial Hospital; BLK Cancer Centre
New Delhi, National Capital Territory of Delhi, 110005
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
New Delhi, National Capital Territory of Delhi, 110085
Max Super Speciality Hospital; Medical Oncology
North WEST Delhi, National Capital Territory of Delhi, 110088
Jehangir Hospital
Pune, Maharashtra, 411001
Japan10 sites
Gunma Prefectural Cancer Center
Gunma, 373-8550
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
Sagara Hospital
Kagoshima, 892-0833
Kanagawa Cancer Center
Kanagawa, 241-8515
Tokai University Hospital
Kanagawa, 259-1193
Niigata Cancer Center Hospital
Niigata, 951-8566
Naha-nishi Clinic
Okinawa, 901-0154
Osaka International Cancer Institute
Osaka, 541-8567
Saitama Cancer Center
Saitama, 362-0806
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Canada9 sites
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Grand River Hospital
Kitchener, Ontario, N2G 1G3
London Regional Cancer Centre
London, Ontario, N6A 4L6
McGill University; Glen Site; Oncology
Montreal, Quebec, H4A 3J1
Hopital du Saint Sacrement
Québec, Quebec, G1S 4L8
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
United States8 sites
Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, 33901-8101
HCA Midwest Health
Kansas City, Missouri, 64132
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060
Tennessee Oncology; Sarah Cannon Research Institute
Nashville, Tennessee, 37203
The Valley Hospital
Paramus, New Jersey, 07652
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, 15213
Florida Cancer Specialist, North Region
St. Petersburg, Florida, 33705
Stanford Cancer Center
Stanford, California, 94305-5820
Turkey (Türkiye)8 sites
Adana Baskent University Medical Faculty; Oncology
Adana, 01220
Ankara Bilkent City Hospital
Ankara, 06490
Uludag University Medical Faculty; Internal Medicine
Bursa, 16059
Dicle Uni Medical Faculty; Internal Medicine
Diyarbakır, 10000
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030
Izmir Ataturk Training and Research Hospital
Izmir, 35965
Kocaeli University Faculty of Medicine; Medical oncology
İzmit, 31380
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
Kadiköy, 34722
Israel7 sites
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, 9112000
Rabin MC; Davidof Center - Oncology Institute
Petah Tikva, 4941492
Sheba Medical Center
Ramat Gan, 5262100
Rambam Health Corporation; Oncology Institute
Rambam, 3525408
Kaplan Medical Center
Rehovot, 7610001
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, 6423906
Assaf Harofeh; Oncology
Ẕerifin, 6093000
Brazil6 sites
Centro de Pesquisas Clinicas em Oncologia - CPCO
Cachoeiro de Itapemirim, Espírito Santo, 29308-014
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, 74605-070
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 90040-373
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia, 40050-410
Hospital Perola Byington
São Paulo, São Paulo, 01317-000
Spain5 sites
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña, LA Coruña, 15006
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036
Hospital Universitario de Fuenlabrada; Servicio de Oncologia
Madrid, 28943
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, 41009
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, 41013
Czechia4 sites
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Králové, 500 05
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00
Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU
Ostrava-Poruba, 70852
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Prague, 128 08
Greece4 sites
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
Athens, 115 22
ARETAIEION UNIVERSITY HOSPITAL; oncology unit
Athens, 115 28
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifissia, 145 64
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, 564 29
Saudi Arabia3 sites
King Fahad Specialist Hospital; Oncology
Dammam, 31444
International Medical Center (IMC)
Jeddah, 21451
King Fahad Medical City; Gastroentrology
Riyadh, 11525
South Africa3 sites
Wilgers Oncology Centre
Pretoria, 0001
Private Oncology Centre
Pretoria, 0081
Sandton Oncology Medical Group
Sandton, 2196
United Kingdom3 sites
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT
Christie Hospital
Manchester, M20 3BG
Mount Vernon Cancer Centre
Northwood, HA6 2RN
Morocco2 sites
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
Marrakesh, 40000
Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie
Rabat, 10000
Romania2 sites
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015
Centrul de Oncologie Sfantul Nectarie
Craiova, 200347
Russia2 sites
Russian Oncology Research Center n.a. N.N. Blokhin
Moscow, Moscow Oblast, 115478
Petrov Research Inst. of Oncology
Saint Petersburg, 197758
Slovakia2 sites
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
Bratislava, 833 10
POKO Poprad; Department of Oncology
Poprad, 058 01
Vietnam2 sites
K hospital
Hanoi, 100000
Hochiminh city oncology hospital
Hochiminh City, 700000
Argentina1 site
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE
About this study
Official title: A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer
This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.
- Conditions
- Triple-Negative Breast Cancer
- Being tested
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Atezolizumab Placebo, Paclitaxel
- 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.
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibodyDrug
Also called MPDL3280A, TECENTRIQ
Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
Atezolizumab PlaceboDrug
Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
PaclitaxelDrug
Paclitaxel will be administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Placebo and Paclitaxel | Placebo comparator | Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody; Drug: Paclitaxel |
| Atezolizumab and Paclitaxel | Experimental | Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. Receives: Drug: Atezolizumab Placebo; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Measured: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Measured: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
Secondary outcomes (20)
Overall Survival (OS) in the PD-L1-Positive Subpopulation
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
Measured: From Day 1 to death from any cause, assessed up 36 months
Overall Survival (OS) in the ITT Population
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
Measured: From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)
Percentage of Participants Who Are Alive at 12 and 18 Months
Measured: From Day 1 to death from any cause, assessed up to 12 and 18 months
Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population
Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.
Measured: From Day 1 to deterioration, assessed up 64 months
Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1
PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Measured: From Day 1 to PD or death from any cause, assessed up to 12 months
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed )
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
Measured: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed)
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD.
Measured: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed )
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
Measured: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed )
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD.
Measured: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)
DOR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Measured: From objective response to PD, assessed up to primary completion date (approximately 26 months)
Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population
Clinical benefit is defined as the achievement of CR, PR, or stable disease according to RECIST v1.1 that lasts for at least 6 months. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference smallest SD since treatment started.
Measured: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population
Measured: Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months).
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population
Measured: C1D1 30 min postdose
Minimum Observed Plasma Concentration (Cmin) of Paclitaxel
Measured: Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)
Maximum Observed Plasma Concentration (Cmax) of Paclitaxel
Measured: Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days)
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Investigator text for AEs is coded using MedDRA version 25.1
Measured: From Day 1 From baseline up to 64 months
Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population
Measured: Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days)
Overall Survival by PD-L1 Status, Intent to Treat Population
Measured: From Day 1 up to 66 months
Progression Free Survival by PD-L1 Status, Intent to Treat Population
Measured: From Day 1 up to primary completion date (approximately 26 months)
Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population
C-DoR is defined as the time from the first occurrence of a documented confirmed response (CR or PR) in C-DOR evaluable population until the date of disease progression per RECIST v1.1 or death from any cause, whichever occurs first. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
Measured: From objective response to PD, assessed up to primary completion date (approximately 26 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start25 Aug 2017
- Primary completion15 Nov 2019
- Study completion17 Jan 2023
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 CancerStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 653 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
- NCT03125902
- Sponsor's protocol ID
- MO39196
- Other IDs
- 2016-004024-29, 2016
- Acronym
- IMpassion131
- Status last verified
- Mar 2024
- First submitted
- 20 Apr 2017
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Miles D, Gligorov J, Andre F, Cameron D, Schneeweiss A, Barrios C, Xu B, Wardley A, Kaen D, Andrade L, Semiglazov V, Reinisch M, Patel S, Patre M, Morales L, Patel SL, Kaul M, Barata T, O'Shaughnessy J; IMpassion131 investigators. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021 Aug;32(8):994-1004. doi: 10.1016/j.annonc.2021.05.801. Epub 2021 Jul 1.
PubMed 34219000