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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03337724
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337724


Contacts
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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

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Locations
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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
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

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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    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for 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