AzTrials
AzTrials

Breast CancerPhase 3IPATunity130NCT03337724

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

A Phase 3 study testing Ipatasertib and Paclitaxel in people with Breast Cancer, run by Hoffmann-La Roche at 176 sites in 30 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 will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Ipatasertib and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
579 participants
Where
176 sitesin 30 countries
Study dates
6 Jan 2018to 4 Jan 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

  • Women or men aged =>18 years with histologically documented triple-negative breast cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate hematologic and organ function within 14 days prior to treatment initiation
  • Histologically documented TNBC or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Eligible for taxane monotherapy, as per local investigator assessment (e.g., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control which may require combination chemotherapy)
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  • HR+/HER2- breast cancer that is not considered appropriate for endocrine-based therapy and meets one of the following: patient has recurrent disease <=5 years of being on adjuvant endocrine therapy or if patient with de novo metastatic disease have progressed within 6 months of being on first line endocrine therapy.
  • Consent to submit a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block or freshly cut unstained, serial tumor slides from the most recently collected tumor tissue for central molecular analysis
  • Confirmation of biomarker eligibility using an appropriately validated molecular assay at a diagnostic laboratory, Clinically Laboratory Improvement Amendments (CLIA) or equivalently accredited i.e., valid results from either central testing or local testing of tumor tissue or blood demonstrating PIK3CA/AKT1/PTEN-altered status
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and agreement to refrain from donating sperm

Who cannot join

  • Treatment with approved or investigational cancer therapy within 14 days prior to treatment initiation
  • Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast (patients receiving neo/adjuvant chemotherapy eligible provided they have at least a 12 month disease-free interval)
  • History of or known presence of brain or spinal cord metastases
  • Malignancies other than breast cancer within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)
  • Prior treatment with an Akt inhibitor (prior PI3K or mTOR inhibitors are allowed)
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills
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  • Active infection requiring systemic anti-microbial treatment (including antibiotics, anti-fungals, and anti-viral agents)
  • Known human immunodeficiency virus (HIV) infection
  • Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of treatment (or anticipated need during study)
  • Pregnant or breastfeeding, or intending to become pregnant during the study
  • Clinically significant cardiac dysfunction (including NYHA Class II/III/IV heart failure, left ventricular ejection fraction [LVEF] <50%, active ventricular arrhythmia requiring medication, history of myocardial infarction within 6 months of treatment initiation, clinically significant electrocardiogram [ECG] abnormalities).
  • Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
  • Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
  • Uncontrolled clinical symptoms including pleural effusion, pericardial effusion, or ascites, tumor-related pain, hypercalcemia (or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy)
  • 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 or active bowel inflammation
  • Clinically significant lung disease (including pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, active infection/ history of opportunistic infections)
  • Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of treatment
  • Grade >=2 peripheral neuropathy

Trial locations and contacts

176 sites in 30 countries.

176 sites in 30 countries

United States28 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy

    Dallas, Texas, 75390

  • West Clinic

    Germantown, Tennessee, 38138

  • Memorial Sloan Kettering Cancer Center at Westchester

    Harrison, New York, 10604

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Oncology Consultants PA

    Houston, Texas, 77030

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • USC Norris Cancer Center

    Los Angeles, California, 90033

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Memorial Sloan Kettering

    New York, New York, 10065

  • USC Norris Cancer Center; USC Oncology Hematology Newport Beach

    Newport Beach, California, 92663

  • Kaiser Permanente - Oakland

    Oakland, California, 94611

  • UF Health Cancer Center at Orlando Health

    Orlando, Florida, 32824

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Kaiser Permanente - Roseville

    Roseville, California, 95661

  • UC Davis; Comprehensive Cancer Center

    Sacramento, California, 95817

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

  • Kaiser Permanente - San Francisco (2238 Geary)

    San Francisco, California, 94115

  • UCSF Comprehensive Cancer Ctr

    San Francisco, California, 94158

  • K. Permanente - San Jose

    San Jose, California, 95119

  • Kaiser Permanente - San Leandro

    San Leandro, California, 94577

  • K. Permanente - Santa Clara

    Santa Clara, California, 95051

  • Kaiser Permanente - South San Francisco

    South San Francisco, California, 94080

  • Kaiser Permanente - Vallejo

    Vallejo, California, 94589

  • K. Permanente - Walnut Creek

    Walnut Creek, California, 94596

Other trials in United States

Japan19 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • National Hospital Organization Kyushu Cancer Center;Breast Oncology

    Fukuoka, 811-1395

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501

  • St. Marianna University Hospital

    Kanagawa, 216-8511

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Tokai University Hospital

    Kanagawa, 259-1193

  • Kumamoto Shinto General Hospital

    Kumamoto, 862-8655

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700-8558

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Kinki University Hospital, Faculty of Medicine; Surgery

    Osaka, 589-8511

  • Saitama Cancer Center, Breast Oncology

    Saitama, 362-0806

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Showa University Hospital; Breast Surgery

    Tokyo, 142-8666

Other trials in Japan

Spain12 sites

  • Hospital del Mar; Servicio de Oncologia

    Barcelona, 08003

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

  • Hospital Clinic Barcelona; Servicio de oncologia

    Barcelona, 08036

  • Hospital Provincial de Castellon; Servicio de Oncologia

    Castellon, Castellon, 12002

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Hospital de Donostia; Servicio de Oncologia

    Guipuzcoa, Guipuzcoa, 20014

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Seville, 41013

  • Hospital Clinico Universitario; Oncologia

    Valencia, 46010

Other trials in Spain

Germany10 sites

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • Praxis Dr.med. Katja Ziegler-Löhr

    Cologne, 50679

  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Freiburg im Breisgau, 79110

  • Universitätsklinikum Hamburg-Eppendorf; Frauenklinik

    Hamburg, 20246

  • Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

    Homburg/Saar, 66424

  • Dres. Andreas Köhler und Roswitha Fuchs

    Langen, 63225

  • Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

    Minden, 32429

  • Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

    Recklinghausen, 45659

  • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

    Rostock, 18059

  • Universitätsklinikum Würzburg; Frauenklinik

    Würzburg, 97080

Other trials in Germany

Russia9 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arhangelsk, 163045

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • SBIH Kaluga Region Clinical Oncology Dispensary

    Kaluga, 248007

  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan

    Kazan', Tatarstan Republic, 420029

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology

    Moscow, Moscow Oblast, 125284

  • Blokhin Cancer Research Center; Combined Treatment

    Moskva, Moscow Oblast, 115478

  • FSI Rostov research oncological institute of MoH and SD of RF; PAD

    Rostov-on-Don, Rostov Oblast, 344037

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

    Saint Petersburg, Sankt-Peterburg, 197758

Other trials in Russia

Brazil8 sites

  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama

    Goiânia, Goiás, 74605-070

  • Hospital do Câncer de Londrina

    Londrina, Paraná, 86015-520

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Nacional de Cancer - INCa; Oncologia

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Santa Casa de Misericordia de Salvador

    Salvador, Estado de Bahia, 40050-410

  • Faculdade de Medicina do ABC - FMABC

    Santo André, São Paulo, 09060-650

  • Hospital Perola Byington

    São Paulo, São Paulo, 01317-000

Other trials in Brazil

Peru8 sites

  • Centro Medico Monte Carmelo

    Arequipa, 04001

  • Hospital Daniel Alcides Carrion

    Callao, 07021

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

    Lima, 15088

  • Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica

    Lima, 15102

  • Oncosalud Sac; Oncología

    Lima, 41

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

  • Clinica Ricardo Palma

    San Isidro, Lima 27

  • Instituto Regional de Enfermedades Neoplasicas - IREN Norte

    Trujillo, 13014

Other trials in Peru

France7 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Centre Georges Francois Leclerc; Oncologie 3

    Dijon, 21079

  • ICM; Medecine B3

    Montpellier, 34298

  • Centre Catherine De Sienne

    Nantes, 44202

  • APHP - Hospital Saint Louis

    Paris, 75475

  • Institut Jean Godinot; Oncologie Medicale

    Reims, 51056

Other trials in France

South Korea7 sites

  • National Cancer Center

    Goyang-si, 10408

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

United Kingdom7 sites

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • University Hospital coventry; Oncology Department

    Coventry, CV2 2DX

  • The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

    Glasgow, G12 0YN

  • Royal Marsden Hospital - London

    London, SW3 6JJ

  • Derriford Hospital

    Plymouth, PL6 8BT

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

  • Royal Marsden Hospital; Dept of Medical Oncology

    Sutton, SM2 5PT

Other trials in United Kingdom

Australia6 sites

  • Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

    Bull Creek, Western Australia, 6149

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Cabrini Medical Centre; Oncology

    Malvern, Victoria, 3144

  • Mater Hospital; Cancer Services

    South Brisbane, Queensland, 4101

  • Calvary Mater Newcastle; Medical Oncology

    Waratah, New South Wales, 2298

  • Westmead Hospital; Medical Oncology

    Wentworthville, New South Wales, 2145

Other trials in Australia

Turkey (Türkiye)6 sites

  • Ankara Bilkent City Hospital

    Ankara, 06490

  • Dicle Uni Medical Faculty; Internal Medicine

    Diyarbakır, 10000

  • Medipol University Medical Faculty; Oncology Department

    Istanbul, 34214

  • Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

    Istanbul, 34384

  • Katip Celebi University Ataturk Training and Research Hospital; Oncology

    Izmir, 35360

  • Sakarya University Medical School; Medical Oncology

    Sakarya, 54100

Other trials in Turkey (Türkiye)

Hungary5 sites

  • Orszagos Onkologial Intezet; Onkologiai Osztaly X

    Budapest, 1122

  • Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

    Miskolc, 3501

  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

    Szeged, 6720

  • Hetenyi Geza County Hospital; Onkologiai Kozpont

    Szolnok, 5004

  • Zala County Hospital ICU

    Zalaegerszeg, 8900

Other trials in Hungary

Italy5 sites

  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

    Aviano, Friuli Venezia Giulia, 33081

  • Ospedale Santa Maria Annunziata; Oncologia

    Bagno a Ripoli, Tuscany, 50012

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

    Bologna, Emilia-Romagna, 40138

  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

    Naples, Campania, 80131

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

    Padova, Veneto, 35128

Other trials in Italy

Mexico4 sites

  • Merida | Investigacion Clinica

    Mérida, Yucatán, 97125

  • Centro Medico Dalinde

    Mexico City, Mexico CITY (federal District), 06760

  • CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO

    Mexico City, 03100

  • Centro Médico Zambrano Hellion

    Monterrey, Nuevo León, 66278

Other trials in Mexico

Taiwan4 sites

  • Chi Mei Medical Center Liou Ying Campus

    Liuying Township, 736

  • VETERANS GENERAL HOSPITAL; Department of General Surgery

    Taipei, 00112

  • National Taiwan Uni Hospital; General Surgery

    Taipei, 100

  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

    Taipei, 11259

Other trials in Taiwan

Ukraine4 sites

  • Chemotherapy SI Dnipropetrovsk MA of MOHU

    Dnipropetrovsk, 49102

  • Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients

    Kiev, 03115

  • National Cancer Institute MOH of Ukraine

    Kiev, 36022

  • Lviv State Oncological Regional Treatment and Diagnostic Center

    Lviv, 79031

Other trials in Ukraine

Belgium3 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • GHdC Site Notre Dame

    Charleroi, 6000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Greece3 sites

  • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

    Athens, 115 22

  • Agioi Anargyroi; 3Rd Dept. of Medical Oncology

    Athens, 145 64

  • Euromedical General Clinic of Thessaloniki; Oncology Department

    Thessaloniki, 546 45

Other trials in Greece

North Macedonia3 sites

  • Clinical Hospital; Oncology Department

    Bitola, 7000

  • PHI University Clinic of Radiotherapy and Oncology; Breast malignancy

    Skopje, 1000

  • PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax

    Skopje, 1000

Other trials in North Macedonia

Poland3 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; III Klin. Radioter. i Chemioter.

    Gliwice, 44-101

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

    Warsaw, 02-781

Other trials in Poland

Argentina2 sites

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD

  • Hosp Provincial D. Centenarios; Oncology Dept

    Rosario, S2002KDS

Other trials in Argentina

Canada2 sites

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Costa Rica2 sites

  • Clinica CIMCA

    San José, 10103

  • ICIMED Instituto de Investigación en Ciencias Médicas

    San José, 10108

Other trials in Costa Rica

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

India2 sites

  • 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

Other trials in India

Singapore2 sites

  • National University Hospital; National University Cancer Institute, Singapore (NCIS)

    Singapore, 119228

  • National Cancer Centre; Medical Oncology

    Singapore, 168583

Other trials in Singapore

Chile1 site

  • Sociedad de Investigaciones Medicas Ltda (SIM)

    Temuco, 4800827

Other trials in Chile

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

South Africa1 site

  • Medical Oncology Centre of Rosebank; Oncology

    Johannesburg, 2196

Other trials in South Africa

About this study

Official title: A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.

Conditions
Breast Cancer
Being tested
Ipatasertib, Paclitaxel, Placebo
Medical subject headings
Breast Neoplasms

What participants receive

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

  • IpatasertibDrug

    Ipatasertib, 400 milligrams (mg), administered orally once a day (QD) on Days 1-21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

  • PaclitaxelDrug

    Paclitaxel, 80 mg/square meter (m^2), administered intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

  • PlaceboDrug

    Matching placebo, administered orally QD on Days 1-21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

Study groups in NCT03337724
Study groupRoleWhat they receive
Ipatasertib + PaclitaxelExperimentalNot described
Receives: Drug: Ipatasertib; Drug: Paclitaxel
Placebo + PaclitaxelExperimentalNot described
Receives: Drug: Paclitaxel; Drug: Placebo

What is being measured

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

  1. Cohort A: Progression-Free Survival (PFS)

    PFS was defined as the time from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or death from any cause, whichever occurred first, assessed up to 27 months for this outcome measure. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters 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 millimeter (mm). The appearance of one or more new lesions was also considered progression.

    Measured: From randomization up to 27 months

  2. Cohort B: PFS

    PFS was defined as the time from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first, assessed up to 24.4 months for this outcome measure. PD was defined as at least a 20% increase in the sum of diameters 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. Abbreviation used in statistical analysis: PI3K=phosphoinositide 3-kinase and mTOR=mammalian target of rapamycin inhibitor.

    Measured: From randomization up to 24.4 months

  3. Cohort C: PFS

    PFS for Cohort C was defined as the time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first, assessed up to 31 months for this outcome measure. PD was defined as at least a 20% increase in the sum of diameters 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: From enrollment up to 31 months

Secondary outcomes (20)

  1. Cohort A and B: Objective Response Rate (ORR)

    ORR was defined as percentage of participants with partial response (PR) or complete response (CR) on 2 consecutive occasions ≥4 weeks apart as determined by the investigator using RECIST v.1.1, assessed up to 27 months for Cohort A and up to 24.4 months for Cohort B, for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages are rounded off to the nearest decimal point.

    Measured: From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B

  2. Cohort C: ORR

    ORR was defined as percentage of participants with PR or CR on 2 consecutive occasions ≥4 weeks apart as determined by the investigator using RECIST v.1.1, assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages are rounded off to the nearest decimal point.

    Measured: From enrollment up to 31 months

  3. Cohort A and B: Duration of Response (DOR)

    DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurred first assessed up to 27 months for Cohort A and up to 24.4 months for Cohort B, for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters 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: From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B

  4. Cohort C: DOR

    DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurred first, assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters 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: From enrollment up to 31 months

  5. Cohort A and B: Clinical Benefit Rate (CBR)

    CBR was defined as percentage of participants with an objective response (CR or PR), or stable disease (SD) for at least 24 weeks, as determined by the investigator through the use of RECIST v.1.1. assessed up to From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages are rounded off to the nearest decimal point.

    Measured: From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B

  6. Cohort C: CBR

    CBR was defined as percentage of participants with an objective response (CR or PR), or SD for at least 24 weeks, as determined by the investigator through the use of RECIST v.1.1 assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages are rounded off to the nearest decimal point.

    Measured: From enrollment up to 31 months

  7. Overall Survival (OS)

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

    Measured: From randomization/ enrollment (Cohort C) up to death from any cause, up to 45 months for Cohort A, up to 46 months for Cohort B and up to 31 months for Cohort C

  8. Cohort A and B: Change From Baseline in Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30

    European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a cancer-specific instrument with 30 questions covering symptoms, functioning, and health-related quality of life (HRQoL). The participant's assessment of overall HRQoL is assessed by using the last 2 questions (29 and 30) of the instrument, with each of these items based on a 7-point scale (1=very poor to 7=excellent), which are then combined into the GHS/QoL multi-item scale. The scores obtained for each question were averaged into a raw score for the scale, and this raw score for the scale was then subsequently linearly transformed to a scale score of 0 to 100, with a high score indicating better GHS/QoL. Negative change from Baseline values in the GHS/QoL change from baseline analysis indicated deterioration in HRQoL and positive values indicated improvement.

    Measured: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 (cycle length=28 days)

  9. Cohort C: Change From Baseline in GHS/HRQoL Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30

    EORTC QLQ-C30 is a cancer-specific instrument with 30 questions covering symptoms, functioning, and health-related quality of life (HRQoL). The participant's assessment of overall HRQoL is assessed by using the last 2 questions (29 and 30) of the instrument, with each of these items based on a 7-point scale (1=very poor to 7=excellent), which are then combined into the GHS/QoL multi-item scale. The scores obtained for each question were averaged into a raw score for the scale, and this raw score for the scale was then subsequently linearly transformed to a scale score of 0 to 100, with a high score indicating better GHS/QoL. Negative change from Baseline values in the GHS/QoL change from baseline analysis indicated deterioration in HRQoL and positive values indicated improvement.

    Measured: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, and 44 (cycle length=28 days)

  10. Cohort B: Time to Deterioration (TTD) in Pain

    Time to deterioration in GHS/HRQoL was defined as the time from randomization to first observed ≥ 11-point increase from Baseline in pain scale score (Question 9 and 19) in EORTC QLQ-C30 linearly transformed GHS/HRQoL scale score, assessed up 24.4 months for this outcome measure. TTD was planned to be assessed only in cohort with HR+/HER2 - breast cancer participants (Cohort B). Questions 9 and 19 that assessed pain, used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scores were linearly transformed on a scale of 0 to 100, with higher scores indicating increased severity in symptoms.

    Measured: Baseline up to 24.4 months

  11. 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 which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.

    Measured: Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C

  12. Number of Participants With at Least One Adverse Events of Special Interest (AESI)

    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 which worsen during a study are also considered as adverse events. AEs were reported based on the NCI CTCAE, Version 4.0. AESI include cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law. Suspected transmission of an infectious agent by the study drug, Grade >= 3 fasting hyperglycemia, hepatotoxicity, diarrhea, rash, ALT/AST elevations. Grade >= 2 colitis/enterocolitis.

    Measured: Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C

  13. Cohorts A and B:Plasma Concentration of Ipatasertib

    Measured: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days)

  14. Cohort C: Plasma Concentration of Ipatasertib

    Measured: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days)

  15. Cohorts A and B: Plasma Concentration of G-037720

    G-037720 was a metabolite of ipatasertib.

    Measured: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days )

  16. Cohort C: Plasma Concentration of G-037720

    G-037720 was a metabolite of ipatasertib.

    Measured: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days )

  17. Cohort C: 1-year Event-free PFS Rate

    PFS was defined as the time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first. Event-free PFS rate was defined as percentage of participants who did not experience any event and survived at 1 year after enrollment. PD was defined as at least a 20% increase in the sum of diameters 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. Percentages are rounded off to the nearest decimal point. As prespecified in the protocol, this outcome measure was applicable only to Cohort C.

    Measured: From enrollment until the occurrence of disease progression or death from any cause, whichever occurred earlier, up to 1 year

  18. Cohort C: 1-year Event-free OS Rate

    OS was defined as the time from enrollment to death from any cause. Event-free OS rate was defined as percentage of participants who did not experience any event and survived at 1 year after enrollment. As prespecified in the protocol, this outcome measure was applicable only to Cohort C. Percentages were rounded off to the nearest decimal.

    Measured: From enrollment up to death from any cause, up to 1 year

  19. Cohort C: Serum Concentration of Atezolizumab

    As prespecified in the protocol, this outcome measure was applicable only to Cohort C.

    Measured: Day 1 of Cycle 1: 30 minutes post dose, predose on Day 15 of Cycle 1 and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length=28 days)

  20. Cohort C: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

    The numbers of ADA-positive participants after drug administration were summarized for participants exposed to atezolizumab. As prespecified in the protocol, this outcome measure was applicable only to Cohort C.

    Measured: Up to 45.5 months

Timeline

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

  1. First posted9 Nov 2017
  2. Study start6 Jan 2018
  3. Primary completion4 Jan 2023
  4. Study completion4 Jan 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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
579 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03337724
Sponsor's protocol ID
CO40016
Other IDs
2017-001548-36, 2017
Acronym
IPATunity130
Status last verified
Feb 2024
First submitted
7 Nov 2017
Last updated
12 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Turner N, Dent RA, O'Shaughnessy J, Kim SB, Isakoff SJ, Barrios C, Saji S, Bondarenko I, Nowecki Z, Lian Q, Reilly SJ, Hinton H, Wongchenko MJ, Kovic B, Mani A, Oliveira M. Ipatasertib plus paclitaxel for PIK3CA/AKT1/PTEN-altered hormone receptor-positive HER2-negative advanced breast cancer: primary results from cohort B of the IPATunity130 randomized phase 3 trial. Breast Cancer Res Treat. 2022 Feb;191(3):565-576. doi: 10.1007/s10549-021-06450-x. Epub 2021 Dec 3.

    PubMed 34860318

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ipatasertib and Paclitaxel in people with Breast Cancer, run by Hoffmann-La Roche at 176 sites in 30 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 11 inclusion and 21 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 12 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 176 sites in United States, Japan, Spain, Germany, Russia and 25 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 12 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?

Cohort A: Progression-Free Survival (PFS) (time frame: From randomization up to 27 months). The study lists 3 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 NCT03337724, which also lists 1 linked publication.

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 12 Mar 2024.

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