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

NCT03337724 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CO400162017-001548-36
• Study Type: interventional
• Target: 579
• Locations: 30 countries
• Sites: 176

Brief 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 growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  From randomization up to 27 months

• 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.

  From randomization up to 24.4 months

• 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.

  From enrollment up to 31 months

Secondary Outcomes (20)

• Cohort A and B: Objective Response Rate (ORR)

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

• Cohort C: ORR

  From enrollment up to 31 months

• Cohort A and B: Duration of Response (DOR)

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

• Cohort C: DOR

  From enrollment up to 31 months

• Cohort A and B: Clinical Benefit Rate (CBR)

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

Study Arms (2)

Ipatasertib + Paclitaxel

EXPERIMENTAL

Drug: Ipatasertib; Drug: Paclitaxel

Placebo + Paclitaxel

EXPERIMENTAL

Drug: Paclitaxel; Drug: Placebo

Interventions

Ipatasertib DRUG

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.

Ipatasertib + Paclitaxel

Paclitaxel DRUG

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.

Ipatasertib + Paclitaxel; Placebo + Paclitaxel

Placebo DRUG

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.

Placebo + Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (176)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

USC Norris Cancer Center

Los Angeles, California, 90033, United States

Location

USC Norris Cancer Center; USC Oncology Hematology Newport Beach

Newport Beach, California, 92663, United States

Location

Kaiser Permanente - Oakland

Oakland, California, 94611, United States

Location

Kaiser Permanente - Roseville

Roseville, California, 95661, United States

Location

UC Davis; Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente Sacramento Medical Center

Sacramento, California, 95825, United States

Location

Kaiser Permanente - San Francisco (2238 Geary)

San Francisco, California, 94115, United States

Location

UCSF Comprehensive Cancer Ctr

San Francisco, California, 94158, United States

Location

K. Permanente - San Jose

San Jose, California, 95119, United States

Location

Kaiser Permanente - San Leandro

San Leandro, California, 94577, United States

Location

K. Permanente - Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente - South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente - Vallejo

Vallejo, California, 94589, United States

Location

K. Permanente - Walnut Creek

Walnut Creek, California, 94596, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

UF Health Cancer Center at Orlando Health

Orlando, Florida, 32824, United States

Location

Memorial Hospital West

Pembroke Pines, Florida, 33028, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

West Clinic

Germantown, Tennessee, 38138, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

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

Dallas, Texas, 75390, United States

Location

Oncology Consultants PA

Houston, Texas, 77030, United States

Location

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, C1125ABD, Argentina

Location

Hosp Provincial D. Centenarios; Oncology Dept

Rosario, S2002KDS, Argentina

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales, 2298, Australia

Location

Westmead Hospital; Medical Oncology

Wentworthville, New South Wales, 2145, Australia

Location

Mater Hospital; Cancer Services

South Brisbane, Queensland, 4101, Australia

Location

Cabrini Medical Centre; Oncology

Malvern, Victoria, 3144, Australia

Location

Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

Bull Creek, Western Australia, 6149, Australia

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

GHdC Site Notre Dame

Charleroi, 6000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Santa Casa de Misericordia de Salvador

Salvador, Estado de Bahia, 40050-410, Brazil

Location

Hospital Araujo Jorge; Departamento de Ginecologia E Mama

Goiânia, Goiás, 74605-070, Brazil

Location

Hospital do Câncer de Londrina

Londrina, Paraná, 86015-520, Brazil

Location

Instituto Nacional de Cancer - INCa; Oncologia

Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Faculdade de Medicina do ABC - FMABC

Santo André, São Paulo, 09060-650, Brazil

Location

Hospital Perola Byington

São Paulo, São Paulo, 01317-000, Brazil

Location

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, 4800827, Chile

Location

Clinica CIMCA

San José, 10103, Costa Rica

Location

ICIMED Instituto de Investigación en Ciencias Médicas

San José, 10108, Costa Rica

Location

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

Brno, 656 53, Czechia

Location

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, 779 00, Czechia

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, 25030, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

Centre Georges Francois Leclerc; Oncologie 3

Dijon, 21079, France

Location

ICM; Medecine B3

Montpellier, 34298, France

Location

Centre Catherine De Sienne

Nantes, 44202, France

Location

APHP - Hospital Saint Louis

Paris, 75475, France

Location

Institut Jean Godinot; Oncologie Medicale

Reims, 51056, France

Location

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, 10707, Germany

Location

Praxis Dr.med. Katja Ziegler-Löhr

Cologne, 50679, Germany

Location

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, 79110, Germany

Location

Universitätsklinikum Hamburg-Eppendorf; Frauenklinik

Hamburg, 20246, Germany

Location

Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

Homburg/Saar, 66424, Germany

Location

Dres. Andreas Köhler und Roswitha Fuchs

Langen, 63225, Germany

Location

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

Minden, 32429, Germany

Location

Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

Recklinghausen, 45659, Germany

Location

Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

Rostock, 18059, Germany

Location

Universitätsklinikum Würzburg; Frauenklinik

Würzburg, 97080, Germany

Location

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

Athens, 115 22, Greece

Location

Agioi Anargyroi; 3Rd Dept. of Medical Oncology

Athens, 145 64, Greece

Location

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, 546 45, Greece

Location

Orszagos Onkologial Intezet; Onkologiai Osztaly X

Budapest, 1122, Hungary

Location

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

Miskolc, 3501, Hungary

Location

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

Szeged, 6720, Hungary

Location

Hetenyi Geza County Hospital; Onkologiai Kozpont

Szolnok, 5004, Hungary

Location

Zala County Hospital ICU

Zalaegerszeg, 8900, Hungary

Location

Indraprastha Apollo Hospitals

New Delhi, National Capital Territory of Delhi, 110076, India

Location

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

New Delhi, National Capital Territory of Delhi, 110085, India

Location

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

Napoli, Campania, 80131, Italy

Location

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

Bologna, Emilia-Romagna, 40138, Italy

Location

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

Aviano, Friuli Venezia Giulia, 33081, Italy

Location

Ospedale Santa Maria Annunziata; Oncologia

Bagno a Ripoli, Tuscany, 50012, Italy

Location

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

Padua, Veneto, 35128, Italy

Location

Aichi Cancer Center Hospital

Aichi, 464-8681, Japan

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

National Hospital Organization Kyushu Cancer Center;Breast Oncology

Fukuoka, 811-1395, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Hyogo Medical University Hospital

Hyōgo, 663-8501, Japan

Location

St. Marianna University Hospital

Kanagawa, 216-8511, Japan

Location

Kanagawa Cancer Center

Kanagawa, 241-8515, Japan

Location

Tokai University Hospital

Kanagawa, 259-1193, Japan

Location

Kumamoto Shinto General Hospital

Kumamoto, 862-8655, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

Location

Kinki University Hospital, Faculty of Medicine; Surgery

Osaka, 589-8511, Japan

Location

Saitama Cancer Center, Breast Oncology

Saitama, 362-0806, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

St. Luke's International Hospital

Tokyo, 104-8560, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Showa University Hospital; Breast Surgery

Tokyo, 142-8666, Japan

Location

Centro Medico Dalinde

Mexico City, Mexico CITY (federal District), 06760, Mexico

Location

Centro Médico Zambrano Hellion

Monterrey, Nuevo León, 66278, Mexico

Location

Merida | Investigacion Clinica

Mérida, Yucatán, 97125, Mexico

Location

CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO

Mexico City, 03100, Mexico

Location

Clinical Hospital; Oncology Department

Bitola, 7000, North Macedonia

Location

PHI University Clinic of Radiotherapy and Oncology; Breast malignancy

Skopje, 1000, North Macedonia

Location

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

Skopje, 1000, North Macedonia

Location

Centro Medico Monte Carmelo

Arequipa, 04001, Peru

Location

Hospital Daniel Alcides Carrion

Callao, 07021, Peru

Location

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

Lima, 15088, Peru

Location

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

Lima, 15102, Peru

Location

Oncosalud Sac; Oncología

Lima, 41, Peru

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

Location

Clinica Ricardo Palma

San Isidro, Lima 27, Peru

Location

Instituto Regional de Enfermedades Neoplasicas - IREN Norte

Trujillo, 13014, Peru

Location

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

?ód?, 93-338, Poland

Location

Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.

Gliwice, 44-101, Poland

Location

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

Warsaw, 02-781, Poland

Location

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Arhangelsk, 163045, Russia

Location

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, 143423, Russia

Location

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

Moscow, Moscow Oblast, 125284, Russia

Location

Blokhin Cancer Research Center; Combined Treatment

Moskva, Moscow Oblast, 115478, Russia

Location

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

Rostov-on-Don, Rostov Oblast, 344037, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

Kazan', Tatarstan Republic, 420029, Russia

Location

Ivanovo Regional Oncology Dispensary

Ivanovo, 153040, Russia

Location

SBIH Kaluga Region Clinical Oncology Dispensary

Kaluga, 248007, Russia

Location

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

Singapore, 119228, Singapore

Location

National Cancer Centre; Medical Oncology

Singapore, 168583, Singapore

Location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

Medical Oncology Centre of Rosebank; Oncology

Johannesburg, 2196, South Africa

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Provincial de Castellon; Servicio de Oncologia

Castellon, Castellon, 12002, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, 14004, Spain

Location

Hospital de Donostia; Servicio de Oncologia

Guipuzcoa, Guipuzcoa, 20014, Spain

Location

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

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Majadahonda, Madrid, 28222, Spain

Location

Hospital del Mar; Servicio de Oncologia

Barcelona, 08003, Spain

Location

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

Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona; Servicio de oncologia

Barcelona, 08036, Spain

Location

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Location

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

Madrid, 28050, Spain

Location

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Seville, 41013, Spain

Location

Hospital Clinico Universitario; Oncologia

Valencia, 46010, Spain

Location

Chi Mei Medical Center Liou Ying Campus

Liuying Township, 736, Taiwan

Location

VETERANS GENERAL HOSPITAL; Department of General Surgery

Taipei, 00112, Taiwan

Location

National Taiwan Uni Hospital; General Surgery

Taipei, 100, Taiwan

Location

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

Taipei, 11259, Taiwan

Location

Ankara Bilkent City Hospital

Ankara, 06490, Turkey (Türkiye)

Location

Dicle Uni Medical Faculty; Internal Medicine

Diyarbakır, 10000, Turkey (Türkiye)

Location

Medipol University Medical Faculty; Oncology Department

Istanbul, 34214, Turkey (Türkiye)

Location

Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

Istanbul, 34384, Turkey (Türkiye)

Location

Katip Celebi University Ataturk Training and Research Hospital; Oncology

Izmir, 35360, Turkey (Türkiye)

Location

Sakarya University Medical School; Medical Oncology

Sakarya, 54100, Turkey (Türkiye)

Location

Chemotherapy SI Dnipropetrovsk MA of MOHU

Dnipropetrovsk, 49102, Ukraine

Location

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

Kiev, 03115, Ukraine

Location

National Cancer Institute MOH of Ukraine

Kiev, 36022, Ukraine

Location

Lviv State Oncological Regional Treatment and Diagnostic Center

Lviv, 79031, Ukraine

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

University Hospital coventry; Oncology Department

Coventry, CV2 2DX, United Kingdom

Location

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

Glasgow, G12 0YN, United Kingdom

Location

Royal Marsden Hospital - London

London, SW3 6JJ, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8BT, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Royal Marsden Hospital; Dept of Medical Oncology

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34860318 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ipatasertib; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 9, 2017
• Study Start: January 6, 2018
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-02

Locations

US (28); GR (3); SG (2); ME (4); FR (7); AR (2); JP (19); KR (7); CL (1); NO (3); BR (8); PE (8); UA (4); CO (2); SL (1); TW (4); CZ (2); HU (5); ZA (1); IT (5); ES (12); PL (3); BE (3); RU (9); GB (7); AU (6); CA (2); DE (10); IN (2); TU (6)