AzTrials
AzTrials

Triple-Negative Breast CancerPhase 3NCT04177108

A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

A Phase 3 study testing Atezolizumab, Ipatasertib and Paclitaxel in people with Triple-Negative Breast Cancer, run by Hoffmann-La Roche at 182 sites in 37 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting. 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, Ipatasertib and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
182 sitesin 37 countries
Study dates
25 Nov 2019to 28 Feb 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Willingness and ability to complete all study-related assessments, including Participant-Reported Outcome (PRO) assessments, in the investigator's judgement.
  • Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1.
  • Life expectancy of at least 6 months.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
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  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
  • Appropriate candidate for paclitaxel monotherapy if tumor programmed death-ligand 1 (PD-L1) status is unknown or non-positive; appropriate candidate for paclitaxel and atezolizumab if tumor PD-L1 status is positive.
  • Histologically documented triple-negative adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent.

Who cannot join

  • Inability to comply with study and follow-up procedures.
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
  • Severe infection within 4 weeks prior to initiation of study treatment (including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia) as well as those who have received treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment.
  • Known human immunodeficiency virus (HIV) infection (there must be a negative HIV test at screening).
  • Known clinically significant history of liver disease consistent with Child-Pugh Class B or C.
  • Current treatment with anti-viral therapy for hepatitis B virus (HBV).
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  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study.
  • Pregnancy or breastfeeding, or intention to become pregnant during the study or within 28 days after the final dose of ipatasertib or (/) placebo, 5 months after the final dose of atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs later.
  • New York Heart Association Class II, III, or IV heart failure, left ventricular ejection fraction less than (<) 50 percent (%), or active ventricular arrhythmia requiring medication.
  • Current unstable angina or history of myocardial infarction within 6 months prior to Day 1 of Cycle 1.
  • Congenital long QT syndrome or screening QT interval corrected through use Fridericia's formula (QTcF) greater than (>) 480 milliseconds (ms).
  • Current treatment with medications used at doses known to cause clinically relevant prolongation of QT/QTc interval.
  • History or presence of an abnormal ECG that is clinically significant in the investigator's opinion (including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction).
  • Requirement for chronic corticosteroid therapy of > 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease.
  • Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk from treatment complications.
  • History of or known presence of spinal cord metastases, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments.
  • Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases.
  • Known germline breast cancer gene (BRCA)1/2 deleterious mutation, unless the participant is not an appropriate candidate for a poly adenosine diphosphate ribose polymerase (PARP)-inhibitor.
  • Any previous systemic therapy for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast.
  • Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
  • Participants who have received palliative radiotherapy to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 may be enrolled in the study if they have recovered from all acute, reversible effects (e.g., to Grade 1 or resolved by enrolment).
  • Uncontrolled pleural effusion, pericardial effusion or ascites.
  • Uncontrolled tumor-related pain.
  • Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer.
  • Known hypersensitivity or contraindication to any component of the study treatments, including the paclitaxel excipient, macrogolglycerol ricinoleate.
  • Grade greater than or equal to (≥) 2 peripheral neuropathy.
  • History of Type I or Type II diabetes mellitus requiring insulin.
  • Grade ≥ 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.
  • History of or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).
  • Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia).
  • Treatment with strong Cytochrome P450 (CYP)3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug.
  • Prior treatment with an Protein kinase B (Akt) inhibitor.
  • Active or history of autoimmune disease or immune deficiency.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezolizumab or within 5 months after the final dose of atezolizumab.
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  • Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies.
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment.
  • Treatment with systemic immunosuppressive medication (including, but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the study.

Trial locations and contacts

182 sites in 37 countries.

182 sites in 37 countries

United States31 sites

  • St. Joseph Mercy Hospital; Cancer Care Center.

    Ann Arbor, Michigan, 48106

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Medstar Franklin Square Medical Center

    Baltimore, Maryland, 21237

  • Ochsner Clinic Foundation

    Baton Rouge, Louisiana, 70809

  • Charleston Oncology, P .A

    Charleston, South Carolina, 29414

  • Rush University

    Chicago, Illinois, 60612

  • Kaiser Permanente - Franklin

    Denver, Colorado, 80205

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • The West Clinic; West Cancer Center

    Germantown, Tennessee, 38138

  • CHI Health Saint Francis; Oncology

    Grand Island, Nebraska, 68803

  • Greenville Health System; Cancer Center

    Greenville, South Carolina, 29605-4292

  • Hackensack Univ Med Ctr

    Hackensack, New Jersey, 07601

  • Memorial Healthcare System - Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Jackson Oncology Associates, PLLC

    Jackson, Mississippi, 39202

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • UCLA

    Los Angeles, California, 90095

  • USA Mitchell Cancer Institute

    Mobile, Alabama, 36688

  • Vanderbilt Univ Medical Ctr

    Nashville, Tennessee, 37203

  • Ochsner Health System

    New Orleans, Louisiana, 70121

  • Memorial Cancer Institute at Memorial West

    Pembroke Pines, Florida, 33028

  • Kaiser Permanente - Portland

    Portland, Oregon, 97227

  • Oregon Health and Science University

    Portland, Oregon, 97229

  • Kaiser Permanente-SCPMG; Oncology Research

    San Diego, California, 92108

  • Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME

    Savannah, Georgia, 31405

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Stamford Hospital; BCC, MOHR

    Stamford, Connecticut, 06904

  • Stanford Cancer Center

    Stanford, California, 94305-5820

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain11 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 Provincial de Castellon; Servicio de Oncologia

    Castellon, Castellon, 12002

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Centro Integral Oncologico Clara Campal; Servicio de Oncología

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia

    Majadahonda, Madrid, 28222

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Sant Andreu de la Barca, Barcelona, 08740

  • Hospital Clínico Universitario de Valencia; Servicio de Oncología

    Valencia, 46010

Other trials in Spain

Australia10 sites

  • Monash Health Monash Medical Centre

    Clayton, Victoria, 3168

  • Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109

  • Peter MacCallum Cancer Centre; Medical Oncology

    Melbourne, Victoria, 3000

  • Mid North Coast Cancer Institute

    Port Macquarie, New South Wales, 2444

  • Sunshine Hospital; Oncology Research

    St Albans, Victoria

  • Royal North Shore Hospital; Department of Medical Oncology

    St Leonards, New South Wales, 2065

  • St John of God Hospital; Bendat Cancer Centre

    Subiaco, Western Australia, 6008

  • Calvary Mater Newcastle; Medical Oncology

    Waratah, New South Wales, 2298

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Russia9 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arhangelsk, 163045

  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan

    Kazan', Tatarstan Republic, 420029

  • University ?linic of headaches

    Moscow, Moscow Oblast, 121467

  • P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

    Moscow, Moscow Oblast, 125284

  • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

    Moskva, Moscow Oblast, 111123

  • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

    Moskva, Moscow Oblast, 115478

  • FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.

    Moskva, Moscow Oblast, 125367

  • Limited Liability Company "RC Medical"

    Novosibirsk, 630005

  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

    Saint Petersburg, Sankt-Peterburg, 197758

Other trials in Russia

Canada8 sites

  • Royal Victoria Hospital

    Barrie, Ontario, L4M 6M2

  • Cross Cancer Institute ; Dept of Medical Oncology

    Edmonton, Alberta, T6G 1Z2

  • Jewish General Hospital; Research Unit

    Montreal, Quebec, H3T 1E2

  • McGill University; Glen Site; Oncology

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K2H 6C2

  • Hopital du Saint Sacrement

    Québec, Quebec, G1S 4L8

  • Fraser Valley Centre British Columbia Cancer Agency

    Surrey, British Columbia, V3V 1Z2

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Italy8 sites

  • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

    Brescia, Lombardy, 25123

  • ASST DI LECCO; Oncologia Medica

    Lecco, Lombardy, 23900

  • Ospedale Civile; Unita Operativa Di Oncologia Medica

    Livorno, Tuscany, 57100

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

    Meldola, Emilia-Romagna, 47014

  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

    Padova, Veneto, 35128

  • IRCCS Istituto Clinico Humanitas; Oncologia

    Rozzano (MI), Lombardy, 20089

  • ASU FC S. M. DELLA MISERICORDIA; Oncologia

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Japan8 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Gunma Prefectural Cancer Center

    Gunma, 373-8550

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Kumamoto Shinto General Hospital

    Kumamoto, 862-8655

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka International Cancer Institute

    Osaka, 541-8567

Other trials in Japan

Peru8 sites

  • Centro Medico Monte Carmelo

    Arequipa, 04001

  • Instituto Regional de Enfermedades Neoplasicas

    Arequipa, 04002

  • Unidad de Investigación Oncologica; Hospital Nacional Daniel Alcides Carrion

    Lima, 07016

  • Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

    Lima, 15088

  • Hospital Arzobispo Loayza

    Lima, 1

  • Oncosalud Sac; Oncología

    Lima, 41

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

  • Clinica Ricardo Palma

    San Isidro, Lima 27

Other trials in Peru

Ukraine7 sites

  • Regional Oncology Center; Department of Mammology

    Chernihiv, 14029

  • Chemotherapy SI Dnipropetrovsk MA of MOHU

    Dnipropetrovsk, 49102

  • SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department

    Kharkiv, Kharkiv Governorate, 61018

  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department

    Kryvyi Rih, 50048

  • MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology

    Kyiv, 04107

  • Municipal Institution Odesa Regional Clinical Hospital

    Odesa, 65025

  • RCI Sumy Regional Clinical Oncological Dispensary

    Sumy, 40005

Other trials in Ukraine

Argentina6 sites

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD

  • Inst. Angel Roffo; Haematology

    Buenos Aires, C1417DTB

  • Hospital Britanico

    Ciudad Autonoma Bs As, C1280AEB

  • Instituto Medico Rio Cuarto

    Córdoba, X5800AEU

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Fundacion Scherbovsky

    Mendoza, M5500AYB

Other trials in Argentina

South Korea6 sites

  • Kyungpook National University Medical Center

    Daegu, 41404

  • National Cancer Center

    Goyang-si, 10408

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Thailand6 sites

  • Chulalongkorn Hospital; Medical Oncology

    Bangkok, 10330

  • Rajavithi Hospital; Division of Medical Oncology

    Bangkok, 10400

  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

    Chiang Mai, 50200

  • Khonkaen Hospital

    Khonkaen, 40000

  • Songklanagarind Hospital; Department of Oncology

    Songkhla, 90110

Other trials in Thailand

Poland5 sites

  • Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej

    ?ód?, 93-338

  • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi

    Gliwice, 44-101

  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

    Krakow, 30-688

  • Wielkopolskie Centrum Onkologii

    Poznan, 61-866

  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr

    Warsaw, 02-781

Other trials in Poland

Portugal5 sites

  • Hospital da Luz; Departamento de Oncologia Medica

    Lisbon, 1500-650

  • Hospital de Santa Maria; Servico de Oncologia Medica

    Lisbon, 1649-035

  • Hospital Beatriz Angelo; Departamento de Oncologia

    Loures, 2674-514

  • Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia

    Porto, 4099-001

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

South Africa5 sites

  • National Hospital; Oncotherapy Dept

    Bloemfontein, 9301

  • Cancercare

    George, 6529

  • Wits Clinical Research

    Johannesberg, 2013

  • Cancercare

    Port Elizabeth, 6045

  • Wilgers Oncology Centre

    Pretoria, 0001

Other trials in South Africa

Austria4 sites

  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

    Innsbruck, 6020

  • Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie

    Linz, 4010

  • Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

    Salzburg, 5020

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

    Vienna, 1090

Other trials in Austria

Brazil4 sites

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo, 01317-001

  • Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

    São Paulo, São Paulo, 04014-002

Other trials in Brazil

Taiwan4 sites

  • China Medical University Hospital; Surgery

    Taichung, 404

  • VETERANS GENERAL HOSPITAL; Department of General Surgery

    Taipei, 00112

  • National Taiwan Uni Hospital; General Surgery

    Taipei, 100

  • Chang Gung Memorial Hosipital at Linkou

    Taoyuan City, 333

Other trials in Taiwan

Finland3 sites

  • Docrates Cance Center

    Helsinki, 00180

  • KYS Sadesairaala; Syopatautien poliklinikka

    Kuopio, 70210

  • VAASAN KESKUSSAIRAALA; Onkologian poliklinikka

    Vaasa, 65130

Other trials in Finland

Hong Kong3 sites

  • Queen Mary Hospital; Dept of Medicine

    Hong Kong

  • Tuen Mun Hospital; Clinical Onc

    Hong Kong

  • Prince of Wales Hospital; Department of Clinical Onocology

    Shatin

Other trials in Hong Kong

Mexico3 sites

  • Investigacion Oncofarmaceutica

    La Paz, Baja California Sur, 23040

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

  • Christus Muguerza Clinica Vidriera

    Monterrey, Nuevo León, 64570

Other trials in Mexico

New Zealand3 sites

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023

  • Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

    Tauranga, 3112

  • Wellington Regional Hospital; Clinical Trials Unit

    Wellington, 6021

Other trials in New Zealand

Turkey (Türkiye)3 sites

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Medipol University Medical Faculty; Oncology Department

    Istanbul, 34214

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Sihhiye/Ankara, 06230

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • BEATSON WEST OF SCOTLAND CANCER CENTRE; Clinical Research Unit ? Level 1

    Glasgow, G12 0YN

  • The Royal Marsden Hospital, Fulham

    London, SW3 6JJ

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

Other trials in United Kingdom

Belgium2 sites

  • AZ Maria Middelares

    Ghent, 9000

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

Other trials in Belgium

Colombia2 sites

  • Clinica del Country

    Bogotá, 11001

  • Oncólogos de Occidente

    Pereira, 600004

Other trials in Colombia

Czechia2 sites

  • Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e

    Brno, 656 53

  • Fakultni nemocnice Olomouc; Onkologicka klinika

    Olomouc, 779 00

Other trials in Czechia

Denmark2 sites

  • Herlev Hospital; Afdeling for Kræftbehandling

    Herlev, 2730

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000

Other trials in Denmark

Greece2 sites

  • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

    Kifissia, 145 64

  • Euromedical General Clinic of Thessaloniki; Oncology Department

    Thessaloniki, 546 45

Other trials in Greece

Switzerland2 sites

  • Universitätsspital Basel

    Basel, 4031

  • Universitätsspital Zürich Gynäkologische Klinik; Klinik für Gynäkologie

    Zurich, 8091

Other trials in Switzerland

Bulgaria1 site

  • MHAT Nadezhda

    Sofia, 1330

Other trials in Bulgaria

Costa Rica1 site

  • Clinica CIMCA

    San José, 10103

Other trials in Costa Rica

France1 site

  • Centre Eugene Marquis; Service d'oncologie

    Rennes, 35042

Other trials in France

India1 site

  • Sahyadri Super Specialty Hospital Hadapsar

    Pune, Maharashtra, 411028

Other trials in India

Israel1 site

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

Other trials in Israel

Romania1 site

  • Oncology Center Sf. Nectarie

    Craiova, 200347

Other trials in Romania

Singapore1 site

  • National Cancer Centre; Medical Oncology

    Singapore, 168583

Other trials in Singapore

About this study

Official title: A Phase III, Double-blind, Placebo-controlled, Randomized Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Patients With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

Being tested
Atezolizumab, Ipatasertib, Paclitaxel, Placebo for Atezolizumab, Placebo for Ipatasertib
Keywords
Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases, Paclitaxel, Atezolizumab, Ipatasertib, Antibodies, Monoclonal, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Atezolizumab was administered as per the dosage regimen mentioned in arm descriptions.

  • IpatasertibDrug

    Ipatasertib was administered as per the dosage regimen mentioned in arm descriptions.

  • PaclitaxelDrug

    Paclitaxel was administered as per the dosage regimen mentioned in arm descriptions.

  • Placebo for AtezolizumabDrug

    Placebo was administered as per the dosage regimen mentioned in arm descriptions.

  • Placebo for IpatasertibDrug

    Placebo was administered as per the dosage regimen mentioned in arm descriptions.

Study groups in NCT04177108
Study groupRoleWhat they receive
Cohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelExperimentalTNBC participants with programmed death-ligand 1 (PD-L1) non-positive received a combination of paclitaxel, 80 milligrams per meter square (mg/m^2), intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, orally (PO), once daily (QD), from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Receives: Drug: Atezolizumab; Drug: Ipatasertib; Drug: Paclitaxel
Cohort 1 Arm B: Ipatasertib + Placebo + PaclitaxelExperimentalTNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Receives: Drug: Ipatasertib; Drug: Paclitaxel; Drug: Placebo for Atezolizumab
Cohort 1 Arm C: Placebo + Placebo + PaclitaxelExperimentalTNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Receives: Drug: Paclitaxel; Drug: Placebo for Atezolizumab; Drug: Placebo for Ipatasertib
Cohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxelExperimentalTNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Receives: Drug: Atezolizumab; Drug: Ipatasertib; Drug: Paclitaxel
Cohort 2 Arm B: Placebo+ Atezolizumab + PaclitaxelExperimentalTNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Receives: Drug: Atezolizumab; Drug: Paclitaxel; Drug: Placebo for Ipatasertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    PFS was defined as the time from randomization to the first occurrence of disease progression as determined locally by RECIST or death from any cause during treatment, whichever occurs first.

    Measured: From Randomization to disease progression, study completion, or death (up to 39 months)

  2. Overall Survival (OS)

    OS was defined as the time from randomization to the time of death from any cause on study.

    Measured: From randomization up to study completion or death (Up to 39 months)

Secondary outcomes (1)

  1. Number of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measured: Up to 39 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2019
  2. Study start25 Nov 2019
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2023

Resources

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
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04177108
Sponsor's protocol ID
CO41101
Other IDs
2019-000810-12, 2019
Status last verified
Feb 2024
First submitted
7 Nov 2019
Last updated
27 Mar 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Ipatasertib and Paclitaxel in people with Triple-Negative Breast Cancer, run by Hoffmann-La Roche at 182 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States, Spain, Australia, Russia, Canada and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: From Randomization to disease progression, study completion, or death (up to 39 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04177108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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