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 (IPATunity130)

• ClinicalTrials.gov Identifier: NCT03337724
• Recruitment Status: Recruiting
• First Posted: November 9, 2017
• Last Update Posted: November 18, 2019
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Ipatasertib; Drug: Paclitaxel; Drug: Placebo	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 6, 2018
• Estimated Primary Completion Date: December 22, 2021
• Estimated Study Completion Date: December 22, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ipatasertib + Paclitaxel	Drug: Ipatasertib; 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.; Drug: Paclitaxel; 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.
Experimental: Placebo + Paclitaxel	Drug: Paclitaxel; 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.; Drug: Placebo; 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.

Outcome Measures

Primary Outcome Measures :

1. Progression-Free Survival (PFS) [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months ]
   Progression-Free Survival (PFS) as determined by the Investigator using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1)

Secondary Outcome Measures :

1. Objective Response Rate (ORR) [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months ]
   Proportion of participants with an objective response (ORR), defined as partial response or complete response on 2 consecutive occasions ≥4 weeks apart) as determined by the Investigator using RECIST v.1.1
2. Duration of Response (DOR) [ Time Frame: Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months ]
   Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause.
3. Clinical Benefit Rate (CBR) [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months ]
   Proportion of participants with a clinical benefit (CB), defined as an objective response (CR or PR), or stable disease for at least 24 weeks, as determined by the Investigator through the use of RECIST v1.1.
4. Overall Survival (OS) [ Time Frame: From randomization up to death from any cause, up to approximately 53 months ]
   Time from randomization to death from any cause.
5. Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score [ Time Frame: From Day 1 of Cycle 1 up to approximately 53 months ]
   GHS/HRQoL scores, assessed using selected questions from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
6. Time to Deterioration in Pain [ Time Frame: From Day 1 of Cycle 1 up to approximately 53 months ]
   Time to deterioration in pain is defined as the first minimally important increase of >10 points from the baseline pain scale score of selected questions of the EORTC QLQ-C30 and will only be assessed in the cohort with HR+/HER2- breast cancer participants.
7. Incidence and Severity of Adverse Events (AEs) [ Time Frame: From randomization up to approximately 53 months ]
   Percentage of participants with an adverse event (AE), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0, including analysis of pre-specified AEs.
8. Changes in Vital Signs [ Time Frame: From randomization up to approximately 53 months ]
   Change from baseline in selected vital signs.
9. Changes in Targeted Laboratory Results [ Time Frame: From randomization up to approximately 53 months ]
   Change from baseline in selected laboratory test results.
10. Plasma Concentration of Ipatasertib and Its Metabolite (G-037720) [ Time Frame: Day 1 and Day 15 of Cycle 1, and on Day 15 of Cycle 3 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• 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

Contacts and Locations

Contacts

Contact: Reference Study ID: CO40016 www.roche.com/about_roche/roche_worldwide.htm; 888-662-6728 (U.S. only); global-roche-genentech-trials@gene.com

  Hide Study Locations

Locations

United States, California

UCSD Moores Cancer Center; Completed

La Jolla, California, United States, 92093

USC Norris Cancer Center; Recruiting

Los Angeles, California, United States, 90033

USC Norris Cancer Center; USC Oncology Hematology Newport Beach; Recruiting

Newport Beach, California, United States, 92663

Kaiser Permanente - Oakland; Recruiting

Oakland, California, United States, 94611

Emad Ibrahim, Md, Inc; Withdrawn

Redlands, California, United States, 92373

Kaiser Permanente - Roseville; Recruiting

Roseville, California, United States, 95661

Kaiser Permanente Sacramento Medical Center; Recruiting

Sacramento, California, United States, 95814

UC Davis; Comprehensive Cancer Center; Recruiting

Sacramento, California, United States, 95817

Kaiser Permanente - San Francisco (2238 Geary); Recruiting

San Francisco, California, United States, 94115

UCSF Comprehensive Cancer Ctr; Recruiting

San Francisco, California, United States, 94158

K. Permanente - San Jose; Recruiting

San Jose, California, United States, 95119

Kaiser Permanente - San Leandro; Recruiting

San Leandro, California, United States, 94577

K. Permanente - Santa Clara; Recruiting

Santa Clara, California, United States, 95051

Kaiser Permanente - South San Francisco; Recruiting

South San Francisco, California, United States, 94080

Kaiser Permanente - Vallejo; Recruiting

Vallejo, California, United States, 94589

K. Permanente - Walnut Creek; Recruiting

Walnut Creek, California, United States, 94596

United States, Florida

Memorial Regional Hospital; Recruiting

Hollywood, Florida, United States, 33021

Mount Sinai Comprehensive Cancer Center; Recruiting

Miami Beach, Florida, United States, 33140

UF Health Cancer Center at Orlando Health; Recruiting

Orlando, Florida, United States, 32824

Memorial Hospital West; Recruiting

Pembroke Pines, Florida, United States, 33028

United States, Illinois

Northwestern Center for Clinical Research; Cancer Center; Withdrawn

Chicago, Illinois, United States, 60611

Rush University Medical Center; Div of Hematology; Withdrawn

Chicago, Illinois, United States, 60612

United States, Maryland

University of Maryland; Recruiting

Baltimore, Maryland, United States, 21201

Mercy Medical Center; Recruiting

Baltimore, Maryland, United States, 21202

John Hopkins Sidney Kimmel Comprehensive Cancer Center; Recruiting

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Mass General/North Shore Cancer; Recruiting

Danvers, Massachusetts, United States, 01923

United States, New York

Westchester Medical Center Cancer Institute; Withdrawn

Hawthorne, New York, United States, 10532

Memorial Sloan Kettering; Recruiting

New York, New York, United States, 10065

United States, Ohio

Mid Ohio Onc Hematology Inc; Withdrawn

Columbus, Ohio, United States, 43219

United States, Oregon

Oregon Health and Science University; Recruiting

Portland, Oregon, United States, 97239

United States, Tennessee

West Clinic; Recruiting

Germantown, Tennessee, United States, 38138

Brig Cancer Care; Withdrawn

Knoxville, Tennessee, United States, 37909

Vanderbilt Breast Center; Vanderbilt Health Pharmacy; Withdrawn

Nashville, Tennessee, United States, 37204

United States, Texas

Texas Oncology, P.A.; Recruiting

Dallas, Texas, United States, 75246

Parkland Hospital; Not yet recruiting

Dallas, Texas, United States, 75390

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

Dallas, Texas, United States, 75390

Houston Methodist Cancer Center; Withdrawn

Houston, Texas, United States, 77030

Oncology Consultants PA; Recruiting

Houston, Texas, United States, 77030

Argentina

Fundación CENIT para la Investigación en Neurociencias; Recruiting

Buenos Aires, Argentina, C1125ABD

Hospital Britanico; Recruiting

Ciudad Autonoma Bs As, Argentina, C1280AEB

Centro Oncologico Riojano Integral (CORI); Recruiting

La Rioja, Argentina, F5300COE

Hosp Provincial D. Centenarios; Oncology Dept; Recruiting

Rosario, Argentina, S2002KDS

Australia, New South Wales

Chris O'Brien Lifehouse; Recruiting

Camperdown, New South Wales, Australia, 2050

Calvary Mater Newcastle; Medical Oncology; Recruiting

Waratah, New South Wales, Australia, 2298

Westmead Hospital; Medical Oncology; Recruiting

Wentworthville, New South Wales, Australia, 2145

Australia, Queensland

Mater Hospital; Cancer Services; Recruiting

South Brisbane, Queensland, Australia, 4101

Australia, Victoria

Cabrini Medical Centre; Oncology; Recruiting

Malvern, Victoria, Australia, 3144

Australia, Western Australia

Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit; Recruiting

Bull Creek, Western Australia, Australia, 6149

Belgium

Cliniques Universitaires St-Luc; Recruiting

Bruxelles, Belgium, 1200

GHdC Site Notre Dame; Recruiting

Charleroi, Belgium, 6000

UZ Leuven Gasthuisberg; Active, not recruiting

Leuven, Belgium, 3000

Brazil

Santa Casa de Misericordia de Salvador; Oncologia; Recruiting

Salvador, BA, Brazil, 40050-410

Hospital Araujo Jorge; Departamento de Ginecologia E Mama; Recruiting

Goiania, GO, Brazil, 74605-070

Hospital do Câncer de Londrina; Recruiting

Londrina, PR, Brazil, 86015-520

Instituto Nacional de Cancer - INCa; Pesquisa Clinica; Recruiting

Rio de Janeiro, RJ, Brazil, 20231-050

Hospital Sao Lucas - PUCRS; Recruiting

Porto Alegre, RS, Brazil, 90610-000

Hospital Nossa Senhora da Conceicao; Recruiting

Porto Alegre, RS, Brazil, 91350-200

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia; Recruiting

Santo André, SP, Brazil, 09060-650

Hospital Perola Byington; Active, not recruiting

Sao Paulo, SP, Brazil, 01317-000

Hospital A. C. Camargo; Oncologia; Active, not recruiting

Sao Paulo, SP, Brazil, 01509-010

Canada, Alberta

Cross Cancer Institute ; Dept of Medical Oncology; Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Canada, British Columbia

Bcca - Cancer Center Southern Interior; Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre; Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Ontario

Sunnybrook Health Sciences Centre; Withdrawn

Toronto, Ontario, Canada, M4N 3M5

Canada, Quebec

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology; Recruiting

Montreal, Quebec, Canada, H3T 1E2

Chile

Servicio de Oncología Hospital Regional e Concepción; Withdrawn

Concepcion, Chile, 4070038

Sociedad de Investigaciones Medicas Ltda (SIM); Recruiting

Temuco, Chile, 4810469

Hospital Base de Valdivia; Unidad de Oncología Médica; Withdrawn

Valdivia, Chile, 5111055

China

Beijing Hospital; Withdrawn

Beijing City, China, 100006

Beijing Cancer Hospital; Withdrawn

Beijing, China, 100142

the First Hospital of Jilin University; Withdrawn

Changchun, China, 130021

Sun Yat-sen Memorial Hospital; Withdrawn

Guangzhou, China, 510000

Zhejiang Cancer Hospital; Withdrawn

Hangzhou, China, 310022

Harbin Medical University Cancer Hospital; Withdrawn

Harbin, China, 150081

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University); Withdrawn

Nanjing City, China, 210029

Jiangsu Cancer Hospital; Withdrawn

Nanjing, China, 210009

Fudan University Shanghai Cancer Center; Withdrawn

Shanghai, China, 200032

Liaoning cancer Hospital & Institute; Withdrawn

Shenyang, China, 110042

Costa Rica

Clinica CIMCA; Active, not recruiting

San Jose, Costa Rica, 10103

ICIMED Instituto de Investigación en Ciencias Médicas; Completed

San Jose, Costa Rica, 10108

Czechia

Masarykův onkologický ústav; Klinika komplexní onkologické péče; Recruiting

Brno, Czechia, 656 53

Fakultni nemocnice Olomouc; Onkologicka klinika; Recruiting

Olomouc, Czechia, 779 00

France

Institut Sainte Catherine; Withdrawn

Avignon, France, 84918

CHU Besançon - Hôpital Jean Minjoz; Active, not recruiting

Besançon Cedex, France, 25030

Polyclinique Bordeaux Nord Aquitaine; Recruiting

Bordeaux, France, 33300

Centre Francois Baclesse; Oncologie; Recruiting

Caen, France, 14076

Centre Georges Francois Leclerc; Oncologie 3; Recruiting

Dijon, France, 21079

Centre Leon Berard; Oncologie Genetique; Withdrawn

Lyon, France, 69373

ICM; Medecine B3; Recruiting

Montpellier cedex 5, France, 34298

Centre Catherine De Sienne; Recruiting

Nantes, France, 44202

APHP - Hospital Saint Louis; Recruiting

Paris, France, 75475

Institut Jean Godinot; Oncologie Medicale; Recruiting

Reims CEDEX, France, 51056

Germany

Onkologische Schwerpunktpraxis Kurfürstendamm; Recruiting

Berlin, Germany, 10707

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR; Recruiting

Freiburg, Germany, 79110

Universitätsklinikum Hamburg-Eppendorf; Frauenklinik; Recruiting

Hamburg, Germany, 20246

Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe; Recruiting

Homburg/Saar, Germany, 66424

Praxis Dr.med. Katja Ziegler-Löhr; Recruiting

Köln, Germany, 50679

Dres. Andreas Köhler und Roswitha Fuchs; Recruiting

Langen, Germany, 63225

Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe; Active, not recruiting

Minden, Germany, 32429

Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie; Recruiting

Recklinghausen, Germany, 45659

Universitätsfrauen- und Poliklinik am Klinikum Suedstadt; Recruiting

Rostock, Germany, 18059

Universitätsklinikum Würzburg; Frauenklinik; Recruiting

Würzburg, Germany, 97080

Greece

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

Athens, Greece, 115 22

ARETAIEION UNIVERSITY HOSPITAL; oncology unit; Recruiting

Athens, Greece, 115 28

Agioi Anargyroi; 3Rd Dept. of Medical Oncology; Recruiting

Athens, Greece, 145 64

Euromedical General Clinic of Thessaloniki; Oncology Department; Active, not recruiting

Thessaloniki, Greece, 546 45

Hungary

Orszagos Onkologial Intezet; Onkologiai Osztaly X; Recruiting

Budapest, Hungary, 1122

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

Miskolc, Hungary, 3501

Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz; Recruiting

Nyiregyhaza, Hungary, 4400

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

Szeged, Hungary, 6720

Hetenyi Geza County Hospital; Onkologiai Kozpont; Recruiting

Szolnok, Hungary, 5004

Zala County Hospital ICU; Recruiting

Zalaegerszeg, Hungary, 8900

India

Indraprastha Apollo Hospitals; Recruiting

New Delhi, Delhi, India, 110076

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology; Not yet recruiting

New Delhi, Delhi, India, 110085

Max Super Speciality Hospital; Medical Oncology; Not yet recruiting

North WEST Delhi, Delhi, India, 110088

HealthCare Global Cancer Centre; Medical Oncology; Recruiting

Ahmedabad, Gujarat, India, 380060

Tata Memorial Hospital; Recruiting

Mumbai, Maharashtra, India, 400013

Grant Medical Foundation, Ruby Hall Clinic; Recruiting

Pune, India, 411001

Italy

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

Napoli, Campania, Italy, 80131

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

Bologna, Emilia-Romagna, Italy, 40138

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

Aviano, Friuli-Venezia Giulia, Italy, 33081

Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica; Withdrawn

Milano, Lombardia, Italy, 20141

Ospedale Santa Maria Annunziata; Oncologia; Recruiting

Bagno a Ripoli, Toscana, Italy, 50012

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

Padova, Veneto, Italy, 35128

Japan

Aichi Cancer Center Hospital; Recruiting

Aichi, Japan, 464-8681

National Cancer Center Hospital East; Recruiting

Chiba, Japan, 277-8577

National Hospital Organization Kyushu Cancer Center;Breast Oncology; Recruiting

Fukuoka, Japan, 811-1395

Fukushima Medical University Hospital; Recruiting

Fukushima, Japan, 960-1295

Hyogo College of Medicine Hospital; Recruiting

Hyogo, Japan, 663-8501

St. Marianna University School of Medicine Hospital; Recruiting

Kanagawa, Japan, 216-8511

Kanagawa Cancer Center; Active, not recruiting

Kanagawa, Japan, 241-8515

Tokai University Hospital; Active, not recruiting

Kanagawa, Japan, 259-1193

Kumamoto Shinto General Hospital; Recruiting

Kumamoto, Japan, 862-8655

Tohoku University Hospital; Recruiting

Miyagi, Japan, 980-8574

Niigata Cancer Center Hospital; Recruiting

Niigata, Japan, 951-8566

Okayama University Hospital; Recruiting

Okayama, Japan, 700-8558

National Hospital Organization Osaka National Hospital; Active, not recruiting

Osaka, Japan, 540-0006

Kinki University Hospital, Faculty of Medicine; Surgery; Recruiting

Osaka, Japan, 589-8511

Saitama Cancer Center, Breast Oncology; Recruiting

Saitama, Japan, 362-0806

Shizuoka Cancer Center; Recruiting

Shizuoka, Japan, 411-8777

National Cancer Center Hospital; Active, not recruiting

Tokyo, Japan, 104-0045

St. Luke's International Hospital; Recruiting

Tokyo, Japan, 104-8560

Juntendo University Hospital; Recruiting

Tokyo, Japan, 113-8431

The Cancer Institute Hospital of JFCR; Recruiting

Tokyo, Japan, 135-8550

Showa University Hospital; Breast Surgery; Recruiting

Tokyo, Japan, 142-8666

Korea, Republic of

National Cancer Center; Active, not recruiting

Gyeonggi-do, Korea, Republic of, 10408

Seoul National University Bundang Hospital; Recruiting

Gyeonggi-do, Korea, Republic of, 13620

Inha University Hospital; Recruiting

Incheon, Korea, Republic of, 22332

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of, 03080

Severance Hospital, Yonsei University Health System; Active, not recruiting

Seoul, Korea, Republic of, 03722

Asan Medical Center - Oncology; Active, not recruiting

Seoul, Korea, Republic of, 05505

Samsung Medical Center; Recruiting

Seoul, Korea, Republic of, 06351

Mexico

Centro Medico Dalinde; Recruiting

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

Centro Médico Zambrano Hellion; Active, not recruiting

Monterrey, Nuevo LEON, Mexico, 66278

Merida | Investigacion Clinica; Completed

Mérida, Yucatan, Mexico, 97125

Consultorio de Medicina Especializada; Dentro de Condominio San Francisco; Recruiting

Mexico City, Mexico, 03100

North Macedonia

Clinical Hospital; Oncology Department; Recruiting

Bitola, North Macedonia, 7000

PHI University Clinic of Radiotherapy and Oncology; Breast malignancy; Recruiting

Skopje, North Macedonia, 1000

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

Skopje, North Macedonia, 1000

Peru

Centro Medico Monte Carmelo; Recruiting

Arequipa, Peru, 04001

Hospital Daniel Alcides Carrion; Recruiting

Callao, Peru, 07021

Instituto Nacional de Enfermedades Neoplasicas; Recruiting

Lima, Peru, 15038

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

Lima, Peru, 15088

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

Lima, Peru, 15102

Oncosalud Sac; Oncología; Active, not recruiting

Lima, Peru, 41

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional; Withdrawn

Lima, Peru, Lima 41

Clinica Ricardo Palma; Recruiting

San Isidro, Peru, Lima 27

Instituto Regional de Enfermedades Neoplasicas - IREN Norte; Active, not recruiting

Trujillo, Peru, 13014

Poland

Centrum Onkologii, Inst.Im M. Curie-Slodowskiej; Iii Klinika Radioterapii I Chemioterapii; Recruiting

Gliwice, Poland, 44-101

Klinika Onkologii Klinicznej CO-I Kraków; Withdrawn

Krakow, Poland

Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych; Withdrawn

Szczecin, Poland, 71-730

Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon; Active, not recruiting

Warszawa, Poland, 02-781

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

Łódź, Poland, 93-338

Russian Federation

Moscow City Oncology Hospital #62; Completed

Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423

Nizhny Novgorod Regional Clinical Oncology Center; Withdrawn

Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603126

Arkhangelsk Regional Clinical Oncology Dispensary; Recruiting

Arkhangelsk, Russian Federation, 163045

Ivanovo Regional Oncology Dispensary; Active, not recruiting

Ivanovo, Russian Federation, 153040

SBIH Kaluga Region Clinical Oncology Dispensary; Completed

Kaluga, Russian Federation, 248007

Clinical Oncology Dispensary of Ministry of Health of Tatarstan; Recruiting

Kazan, Russian Federation, 420029

Blokhin Cancer Research Center; Combined Treatment; Withdrawn

Moscow, Russian Federation, 115478

Blokhin Cancer Research Center; Combined Treatment; Recruiting

Moscow, Russian Federation, 115478

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

Moscow, Russian Federation, 125284

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

Rostov-on-Don, Russian Federation, 344037

SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF; Withdrawn

Ryazan, Russian Federation, 390011

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

Saint-Petersburg, Russian Federation, 197758

Singapore

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

Singapore, Singapore, 119228

National Cancer Centre; Medical Oncology; Recruiting

Singapore, Singapore, 169610

Slovenia

Institute of Oncology Ljubljana; Recruiting

Ljubljana, Slovenia, 1000

Univerzitetni klinični center Maribor; Oddelek za onkologijo; Withdrawn

Maribor, Slovenia, 2000

South Africa

The Oncology Center; Recruiting

Durban, South Africa, 4091

Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital; Not yet recruiting

Johannesburg, South Africa, 2193

Medical Oncology Centre of Rosebank; Oncology; Recruiting

Johannesburg, South Africa, 2196

Langenhoven Drive Oncology Centre; Recruiting

Port Elizabeth, South Africa, 6045

Steve Biko Academic Hospital; Oncology; Recruiting

Pretoria, South Africa, 0002

Spain

Hospital Provincial de Castellon; Servicio de Oncologia; Recruiting

Castellon DE LA Plana/castello DE LA Plana, Castellon, Spain, 12002

Hospital Universitario Reina Sofia; Servicio de Oncologia; Recruiting

Córdoba, Cordoba, Spain, 14004

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

Santiago de Compostela, LA Coruña, Spain, 15706

Hospital Universitario Puerta de Hierro; Servicio de Oncologia; Recruiting

Majadahonda, Madrid, Spain, 28222

Hospital del Mar; Servicio de Oncologia; Recruiting

Barcelona, Spain, 08003

Hospital Univ Vall d'Hebron; Servicio de Oncologia; Recruiting

Barcelona, Spain, 08035

Hospital Clinic Barcelona; Servicio de oncologia; Recruiting

Barcelona, Spain, 08036

Hospital de Donostia; Servicio de Oncologia; Recruiting

Guipuzcoa, Spain, 20014

Hospital Ramon y Cajal; Servicio de Oncologia; Recruiting

Madrid, Spain, 28034

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

Madrid, Spain, 28050

Hospital Universitario Virgen del Rocio; Servicio de Oncologia; Recruiting

Sevilla, Spain, 41013

Hospital Clinico Universitario; Oncologia; Recruiting

Valencia, Spain, 46010

Hospital Universitario Miguel Servet; Servicio de Oncologia Medica; Recruiting

Zaragoza, Spain, 50009

Taiwan

Changhua Christian Hospital; Dept of Surgery; Withdrawn

Changhua, Taiwan, 500

Chi Mei Medical Center Liou Ying Campus; Completed

Liuying Township, Taiwan, 736

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

Taipei City, Taiwan, 11259

VETERANS GENERAL HOSPITAL; Department of General Surgery; Recruiting

Taipei, Taiwan, 00112

National Taiwan Uni Hospital; General Surgery; Recruiting

Taipei, Taiwan, 100

Turkey

Adana Baskent University Hospital; Medical Oncology; Recruiting

Adana, Turkey, 01120

Ankara Onkoloji Eğitim ve Araştırma Hastanesi; Recruiting

Ankara, Turkey, 06200

Ankara City Hospital; Recruiting

Ankara, Turkey, 06490

Dicle Uni Medical Faculty; Internal Medicine; Recruiting

Diyarbakir, Turkey, 10000

Medipol University MF; Oncology Department; Recruiting

Istanbul, Turkey, 34214

Okmeydani T and R Hospital; Med Onc; Recruiting

Istanbul, Turkey, 34384

Katip Celebi University Ataturk Training and Research Hospital; Oncology; Recruiting

Izmir, Turkey, 35360

Sakarya University Medical School; Medical Oncology; Recruiting

Sakarya, Turkey, 54100

Ukraine

Municipal Institution Odesa Regional Oncology Dispensary; Withdrawn

Odesa, KIEV Governorate, Ukraine, 65055

CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU; Recruiting

Dnipropetrovsk, Ukraine, 49102

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

Kiev, Ukraine, 03115

National Cancer Institute MOH of Ukraine; Recruiting

Kiev, Ukraine, 36022

Treatment and Prevention Institution Volyn Regional Oncology Dispensary; Withdrawn

Lutsk, Ukraine, 43018

Lviv State Oncological Regional Treatment and Diagnostic Center; Active, not recruiting

Lviv, Ukraine, 79031

United Kingdom

Velindre Cancer Centre; Recruiting

Cardiff, United Kingdom, CF14 2TL

University Hospital coventry; Oncology Department; Recruiting

Coventry, United Kingdom, CV2 2DX

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

Glasgow, United Kingdom, G12 0YN

Royal Marsden Hospital - London; Recruiting

London, United Kingdom, SW3 6JJ

Derriford Hospital; Recruiting

Plymouth, United Kingdom, PL6 8DH

Royal Stoke University Hospital; Recruiting

Stoke on Trent, United Kingdom, ST4 6QG

Royal Marsden Hospital; Dept of Medical Oncology; Recruiting

Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03337724 History of Changes
• Other Study ID Numbers: CO40016; 2017-001548-36 ( EudraCT Number )
• First Posted: November 9, 2017
• Last Update Posted: November 18, 2019
• Last Verified: November 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Paclitaxel; Albumin-Bound Paclitaxel; Hormones; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs