Clinical Trial - NCT03337724

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

Recruiting

Sponsor: Hoffmann-La Roche

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03337724

Protocol Info

Short Description: Ipataserib + Paclitaxel in Breast Cancer (IPATunity130)
Long Description: A Double-Blind, Placebo-Controlled, Randomized, Phase III Study of Ipataserib 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
MGH Status: Open
Sponsor: Hoffman-LaRoche
Disease Program: Breast

Next Steps


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Purpose

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 Title Intervention Phase
Breast Cancer Ipatasertib Paclitaxel Placebo Phase 2/Phase 3
Study Type Interventional
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

Primary Outcome Measures

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] [Designated as safety issue: ]


Secondary Outcome Measures

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] [Designated as safety issue: ]

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] [Designated as safety issue: ]

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] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: From randomization up to death from any cause, up to approximately 53 months] [Designated as safety issue: ]

Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score [Time Frame: From Day 1 of Cycle 1 up to approximately 53 months] [Designated as safety issue: ]

Time to Deterioration in Pain [Time Frame: From Day 1 of Cycle 1 up to approximately 53 months] [Designated as safety issue: ]

Incidence and Severity of Adverse Events (AEs) [Time Frame: From randomization up to approximately 53 months] [Designated as safety issue: ]

Changes in Vital Signs [Time Frame: From randomization up to approximately 53 months] [Designated as safety issue: ]

Changes in Targeted Laboratory Results [Time Frame: From randomization up to approximately 53 months] [Designated as safety issue: ]

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] [Designated as safety issue: ]

Estimated Enrollment: 450
Study Start Date: January 2018
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021
Arms Assigned Interventions

Experimental:Ipatasertib + 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.

Experimental:Placebo + Paclitaxel

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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT03337724

Locations

  • United States, California
    • UCSD Moores Cancer Center La Jolla, California, United States, 92093
    • USC Norris Cancer Center Los Angeles, California, United States, 90033
    • USC Norris Cancer Center; USC Oncology Hematology Newport Beach Newport Beach, California, United States, 92663
    • Kaiser Permanente - Oakland Oakland, California, United States, 94611
    • Emad Ibrahim, Md, Inc Redlands, California, United States, 92373
    • Kaiser Permanente - Roseville Roseville, California, United States, 95661
    • Kaiser Permanente Sacramento Medical Center Sacramento, California, United States, 95814
    • UC Davis; Comprehensive Cancer Center Sacramento, California, United States, 95817
    • Kaiser Permanente - San Francisco (2238 Geary) San Francisco, California, United States, 94115
    • UCSF Comprehensive Cancer Ctr San Francisco, California, United States, 94115
    • K. Permanente - San Jose San Jose, California, United States, 95119
    • Kaiser Permanente - San Leandro San Leandro, California, United States, 94577
    • K. Permanente - Santa Clara Santa Clara, California, United States, 95051
    • Kaiser Permanente - South San Francisco South San Francisco, California, United States, 94080
    • Kaiser Permanente - Vallejo Vallejo, California, United States, 94589
    • K. Permanente - Walnut Creek Walnut Creek, California, United States, 94596
  • United States, Florida
    • Memorial Regional Hospital Hollywood, Florida, United States, 33021
    • Mount Sinai Comprehensive Cancer Center Miami Beach, Florida, United States, 33140
    • UF Health Cancer Center at Orlando Health Orlando, Florida, United States, 32824
    • Memorial Hospital West Pembroke Pines, Florida, United States, 33028
  • United States, Illinois
    • Northwestern Center for Clinical Research; Cancer Center Chicago, Illinois, United States, 60611
    • Rush University Medical Center; Div of Hematology Chicago, Illinois, United States, 60612
  • United States, Maryland
    • University of Maryland Baltimore, Maryland, United States, 21201
    • Mercy Medical Center Baltimore, Maryland, United States, 21202
    • John Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
    • Mass General/North Shore Cancer Danvers, Massachusetts, United States, 01923
  • United States, New York
    • Westchester Medical Center Cancer Institute Hawthorne, New York, United States, 10532
    • Memorial Sloan Kettering New York, New York, United States, 10065
  • United States, Ohio
    • Mid Ohio Onc Hematology Inc Columbus, Ohio, United States, 43219
  • United States, Oregon
    • Oregon Health and Science University Portland, Oregon, United States, 97239
  • United States, Tennessee
    • West Clinic Germantown, Tennessee, United States, 38138
    • Brig Cancer Care Knoxville, Tennessee, United States, 37909
    • Vanderbilt Breast Center; Vanderbilt Health Pharmacy Nashville, Tennessee, United States, 37204
  • United States, Texas
    • Texas Oncology, P.A. Dallas, Texas, United States, 75246
    • UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy Dallas, Texas, United States, 75390
    • Houston Methodist Cancer Center Houston, Texas, United States, 77030
    • Oncology Consultants PA Houston, Texas, United States, 77030
  • Argentina,
    • Fundación CENIT para la Investigación en Neurociencias Buenos Aires, , Argentina, C1125ABD
    • Hospital Britanico Ciudad Autonoma Bs As, , Argentina, C1280AEB
    • Centro Oncologico Riojano Integral (CORI) La Rioja, , Argentina, F5300COE
    • Hosp Provincial D. Centenarios; Oncology Dept Rosario, , Argentina, S2002KDS
  • Australia, New South Wales
    • Chris O'Brien Lifehouse Camperdown, New South Wales, Australia, 2050
    • Calvary Mater Newcastle; Medical Oncology Waratah, New South Wales, Australia, 2298
    • Westmead Hospital; Medical Oncology Wentworthville, New South Wales, Australia, 2145
  • Australia, Queensland
    • Mater Hospital; Cancer Services South Brisbane, Queensland, Australia, 4101
  • Australia, Victoria
    • Cabrini Medical Centre; Oncology Malvern, Victoria, Australia, 3144
  • Australia, Western Australia
    • Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit Bull Creek, Western Australia, Australia, 6149
  • Belgium,
    • Cliniques Universitaires St-Luc Bruxelles, , Belgium, 1200
    • GHdC Site Notre Dame Charleroi, , Belgium, 6000
    • UZ Leuven Gasthuisberg Leuven, , Belgium, 3000
  • Brazil, BA
    • Santa Casa de Misericordia de Salvador; Oncologia Salvador, BA, Brazil, 40050-410
  • Brazil, GO
    • Hospital Araujo Jorge; Departamento de Ginecologia E Mama Goiania, GO, Brazil, 74605-070
  • Brazil, PR
    • Hospital do Câncer de Londrina Londrina, PR, Brazil, 86015-520
  • Brazil, RJ
    • Instituto Nacional de Cancer - INCa; Pesquisa Clinica Rio De Janerio, RJ, Brazil, 20560-120
  • Brazil, RS
    • Hospital Sao Lucas - PUCRS Porto Alegre, RS, Brazil, 90610-000
    • Hospital Nossa Senhora da Conceicao Porto Alegre, RS, Brazil, 91350-200
  • Brazil, SP
    • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia Santo André, SP, Brazil, 09060-650
    • Hospital Perola Byington Sao Paulo, SP, Brazil, 01317-000
    • Hospital A. C. Camargo; Oncologia Sao Paulo, SP, Brazil, 01509-010
  • Canada, Alberta
    • Cross Cancer Institute ; Dept of Medical Oncology Edmonton, Alberta, Canada, T6G 1Z2
  • Canada, British Columbia
    • Bcca - Cancer Center Southern Interior Kelowna, British Columbia, Canada, V1Y 5L3
    • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre Vancouver, British Columbia, Canada, V5Z 4E6
  • Canada, Ontario
    • Sunnybrook Health Sciences Centre Toronto, Ontario, Canada, M4N 3M5
  • Canada, Quebec
    • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology Montreal, Quebec, Canada, H3T 1E2
  • Chile,
    • Servicio de Oncología Hospital Regional e Concepción Concepcion, , Chile, 4070038
    • Sociedad de Investigaciones Medicas Ltda (SIM) Temuco, , Chile, 4810469
    • Hospital Base de Valdivia; Unidad de Oncología Médica Valdivia, , Chile, 5111055
  • China,
    • Beijing Hospital Beijing City, , China, 100006
    • Beijing Cancer Hospital Beijing, , China, 100142
    • the First Hospital of Jilin University Changchun, , China, 130021
    • Sun Yat-sen Memorial Hospital Guangzhou, , China, 510000
    • Zhejiang Cancer Hospital Hangzhou, , China, 310022
    • Harbin Medical University Cancer Hospital Harbin, , China, 150081
    • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) Nanjing City, , China, 210029
    • Jiangsu Cancer Hospital Nanjing, , China, 210009
    • Fudan University Shanghai Cancer Center Shanghai, , China, 200032
    • Liaoning cancer Hospital & Institute Shenyang, , China, 110042
  • Costa Rica,
    • Clinica CIMCA San Jose, , Costa Rica, 10103
    • ICIMED Instituto de Investigación en Ciencias Médicas San Jose, , Costa Rica, 10108
  • Czechia,
    • Masarykův onkologický ústav; Klinika komplexní onkologické péče Brno, , Czechia, 656 53
    • Fakultni nemocnice Olomouc; Onkologicka klinika Olomouc, , Czechia, 779 00
  • France,
    • Institut Sainte Catherine Avignon, , France, 84918
    • CHU Besançon - Hôpital Jean Minjoz Besançon Cedex, , France, 25030
    • Polyclinique Bordeaux Nord Aquitaine Bordeaux, , France, 33300
    • Centre Francois Baclesse; Oncologie Caen, , France, 14076
    • Centre Georges Francois Leclerc; Oncologie 3 Dijon, , France, 21079
    • Centre Leon Berard; Oncologie Genetique Lyon, , France, 69373
    • ICM; Medecine B3 Montpellier cedex 5, , France, 34298
    • Centre Catherine De Sienne Nantes, , France, 44202
    • APHP - Hospital Saint Louis Paris, , France, 75475
    • Institut Jean Godinot; Oncologie Medicale Reims CEDEX, , France, 51056
  • Germany,
    • Onkologische Schwerpunktpraxis Kurfürstendamm Berlin, , Germany, 10707
    • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR Freiburg, , Germany, 79110
    • Universitätsklinikum Hamburg-Eppendorf; Frauenklinik Hamburg, , Germany, 20246
    • Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe Homburg/Saar, , Germany, 66424
    • Praxis Dr.med. Katja Ziegler-Löhr Köln, , Germany, 50679
    • Dres. Andreas Köhler und Roswitha Fuchs Langen, , Germany, 63225
    • Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe Minden, , Germany, 32429
    • Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie Recklinghausen, , Germany, 45659
    • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt Rostock, , Germany, 18059
    • Universitätsklinikum Würzburg; Frauenklinik Würzburg, , Germany, 97080
  • Greece,
    • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine Athens, , Greece, 115 22
    • ARETAIEION UNIVERSITY HOSPITAL; oncology unit Athens, , Greece, 115 28
    • Agioi Anargyroi; 3Rd Dept. of Medical Oncology Athens, , Greece, 145 64
    • Euromedical General Clinic of Thessaloniki; Oncology Department Thessaloniki, , Greece, 546 45
  • Hungary,
    • Orszagos Onkologial Intezet; Onkologiai Osztaly X Budapest, , Hungary, 1122
    • Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly Miskolc, , Hungary, 3501
    • Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz Nyiregyhaza, , Hungary, 4400
    • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika Szeged, , Hungary, 6720
    • Hetenyi Geza County Hospital; Onkologiai Kozpont Szolnok, , Hungary, 5004
    • Zala County Hospital ICU Zalaegerszeg, , Hungary, 8900
  • India, Delhi
    • Indraprastha Apollo Hospitals New Delhi, Delhi, India, 110076
    • Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology New Delhi, Delhi, India, 110085
    • Max Super Speciality Hospital; Medical Oncology North WEST Delhi, Delhi, India, 110088
  • India, Gujarat
    • HealthCare Global Cancer Centre; Medical Oncology Ahmedabad, Gujarat, India, 380060
  • India, Maharashtra
    • Tata Memorial Hospital Mumbai, Maharashtra, India, 400013
  • India,
    • Grant Medical Foundation, Ruby Hall Clinic Pune, , India, 411001
  • Italy, Campania
    • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica Napoli, Campania, Italy, 80131
  • Italy, Emilia-Romagna
    • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica Bologna, Emilia-Romagna, Italy, 40138
  • Italy, Friuli-Venezia Giulia
    • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica Aviano, Friuli-Venezia Giulia, Italy, 33081
  • Italy, Lombardia
    • Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica Milano, Lombardia, Italy, 20141
  • Italy, Toscana
    • Ospedale Santa Maria Annunziata; Oncologia Bagno a Ripoli, Toscana, Italy, 50012
  • Italy, Veneto
    • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II Padova, Veneto, Italy, 35128
  • Japan,
    • Aichi Cancer Center Hospital Aichi, , Japan, 464-8681
    • National Cancer Center Hospital East Chiba, , Japan, 277-8577
    • National Hospital Organization Kyushu Cancer Center;Breast Oncology Fukuoka, , Japan, 811-1395
    • Fukushima Medical University Hospital Fukushima, , Japan, 960-1295
    • Hyogo College of Medicine Hospital Hyogo, , Japan, 663-8501
    • St. Marianna University School of Medicine Hospital Kanagawa, , Japan, 216-8511
    • Kanagawa Cancer Center Kanagawa, , Japan, 241-8515
    • Tokai University Hospital Kanagawa, , Japan, 259-1193
    • Kumamoto Shinto General Hospital Kumamoto, , Japan, 862-8655
    • Tohoku University Hospital Miyagi, , Japan, 980-8574
    • Niigata Cancer Center Hospital Niigata, , Japan, 951-8566
    • Okayama University Hospital Okayama, , Japan, 700-8558
    • National Hospital Organization Osaka National Hospital Osaka, , Japan, 540-0006
    • Kinki University Hospital, Faculty of Medicine; Surgery Osaka, , Japan, 589-8511
    • Saitama Cancer Center, Breast Oncology Saitama, , Japan, 362-0806
    • Shizuoka Cancer Center Shizuoka, , Japan, 411-09340
    • National Cancer Center Hospital Tokyo, , Japan, 104-0045
    • St. Luke's International Hospital Tokyo, , Japan, 104-8560
    • Juntendo University Hospital Tokyo, , Japan, 113-8431
    • The Cancer Institute Hospital of JFCR Tokyo, , Japan, 135-8550
    • Showa University Hospital; Breast Surgery Tokyo, , Japan, 142-8666
  • Korea, Republic of,
    • National Cancer Center Gyeonggi-do, , Korea, Republic of, 10408
    • Seoul National University Bundang Hospital Gyeonggi-do, , Korea, Republic of, 13620
    • Inha University Hospital Incheon, , Korea, Republic of, 22332
    • Seoul National University Hospital Seoul, , Korea, Republic of, 03080
    • Severance Hospital, Yonsei University Health System Seoul, , Korea, Republic of, 03722
    • Asan Medical Center - Oncology Seoul, , Korea, Republic of, 05505
    • Samsung Medical Center Seoul, , Korea, Republic of, 6351
  • Mexico, Mexico CITY (federal District)
    • Centro Medico Dalinde Cdmx, Mexico CITY (federal District), Mexico, 06760
  • Mexico, Nuevo LEON
    • Centro Médico Zambrano Hellion Monterrey, Nuevo LEON, Mexico, 66278
  • Mexico, Yucatan
    • Merida | Investigacion Clinica Mérida, Yucatan, Mexico, 97125
  • Mexico,
    • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco Mexico City, , Mexico, 03100
  • North Macedonia,
    • Clinical Hospital; Oncology Department Bitola, , North Macedonia, 7000
    • PHI University Clinic of Radiotherapy and Oncology; Breast malignancy Skopje, , North Macedonia, 1000
    • PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax Skopje, , North Macedonia, 1000
  • Peru,
    • Centro Medico Monte Carmelo Arequipa, , Peru, 04001
    • Hospital Daniel Alcides Carrion Callao, , Peru, 07021
    • Instituto Nacional de Enfermedades Neoplasicas Lima, , Peru, 15038
    • Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel Lima, , Peru, 15088
    • Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica Lima, , Peru, 15102
    • Oncosalud Sac; Oncología Lima, , Peru, 41
    • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional Lima, , Peru, Lima 41
    • Clinica Ricardo Palma San Isidro, , Peru, Lima 27
    • Instituto Regional de Enfermedades Neoplasicas - IREN Norte Trujillo, , Peru, 13014
  • Poland,
    • Centrum Onkologii, Inst.Im M. Curie-Slodowskiej; Iii Klinika Radioterapii I Chemioterapii Gliwice, , Poland, 44-101
    • Klinika Onkologii Klinicznej CO-I Kraków Krakow, , Poland,
    • Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych Szczecin, , Poland, 71-730
    • Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon Warszawa, , Poland, 02-781
    • Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej Łódź, , Poland, 93-338
  • Russian Federation, Moskovskaja Oblast
    • Moscow City Oncology Hospital #62 Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
  • Russian Federation, Niznij Novgorod
    • Nizhny Novgorod Regional Clinical Oncology Center Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603126
  • Russian Federation,
    • Arkhangelsk Regional Clinical Oncology Dispensary Arkhangelsk, , Russian Federation, 163045
    • Ivanovo Regional Oncology Dispensary Ivanovo, , Russian Federation, 153040
    • SBIH Kaluga Region Clinical Oncology Dispensary Kaluga, , Russian Federation, 248007
    • Clinical Oncology Dispensary of Ministry of Health of Tatarstan Kazan, , Russian Federation, 420029
    • Blokhin Cancer Research Center; Combined Treatment Moscow, , Russian Federation, 115478
    • Blokhin Cancer Research Center; Combined Treatment Moscow, , Russian Federation, 115478
    • Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology Moscow, , Russian Federation, 125284
    • FSI Rostov research oncological institute of MoH and SD of RF; PAD Rostov-on-Don, , Russian Federation, 344037
    • SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF Ryazan, , Russian Federation, 390011
    • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) Saint-Petersburg, , Russian Federation, 197758
  • Singapore,
    • National University Hospital; National University Cancer Institute, Singapore (NCIS) Singapore, , Singapore, 119228
    • National Cancer Centre; Medical Oncology Singapore, , Singapore, 169610
  • Slovenia,
    • Institute of Oncology Ljubljana Ljubljana, , Slovenia, 1000
    • Univerzitetni klinični center Maribor; Oddelek za onkologijo Maribor, , Slovenia, 2000
  • South Africa,
    • The Oncology Center Durban, , South Africa, 4091
    • Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital Johannesburg, , South Africa, 2193
    • Medical Oncology Centre of Rosebank; Oncology Johannesburg, , South Africa, 2196
    • Langenhoven Drive Oncology Centre Port Elizabeth, , South Africa, 6045
    • Steve Biko Academic Hospital; Oncology Pretoria, , South Africa, 0002
  • Spain, Cordoba
    • Hospital Universitario Reina Sofia; Servicio de Oncologia Córdoba, Cordoba, Spain, 14004
  • Spain, LA Coruña
    • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Santiago de Compostela, LA Coruña, Spain, 15706
  • Spain,
    • Hospital del Mar; Servicio de Oncologia Barcelona, , Spain, 08003
    • Hospital Univ Vall d'Hebron; Servicio de Oncologia Barcelona, , Spain, 08035
    • Hospital Clinic Barcelona; Servicio de oncologia Barcelona, , Spain, 08036
    • Hospital Provincial de Castellon; Servicio de Oncologia Castellon, , Spain, 12002
    • Hospital de Donostia; Servicio de Oncologia Guipuzcoa, , Spain, 20014
    • Hospital Ramon y Cajal; Servicio de Oncologia Madrid, , Spain, 28034
    • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia Madrid, , Spain, 28050
    • Hospital Universitario Puerta de Hierro; Servicio de Oncologia Madrid, , Spain, 28222
    • Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla, , Spain, 41013
    • Hospital Clinico Universitario; Oncologia Valencia, , Spain, 46010
    • Hospital Universitario Miguel Servet; Servicio de Oncologia Medica Zaragoza, , Spain, 50009
  • Taiwan,
    • Changhua Christian Hospital; Dept of Surgery Changhua, , Taiwan, 500
    • Chi Mei Medical Center Liou Ying Campus Liuying Township, , Taiwan, 736
    • VETERANS GENERAL HOSPITAL; Department of General Surgery Taipei, , Taiwan, 00112
    • National Taiwan Uni Hospital; General Surgery Taipei, , Taiwan, 100
    • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology Taipei, , Taiwan, 112
  • Turkey,
    • Adana Baskent University Hospital; Medical Oncology Adana, , Turkey, 01120
    • Ankara Onkoloji Eğitim ve Araştırma Hastanesi Ankara, , Turkey, 06200
    • Ankara City Hospital Ankara, , Turkey, 06490
    • Dicle Uni Medical Faculty; Internal Medicine Diyarbakir, , Turkey, 10000
    • Medipol University MF; Oncology Department Istanbul, , Turkey, 34214
    • Okmeydani T and R Hospital; Med Onc Istanbul, , Turkey, 34384
    • Katip Celebi University Ataturk Training and Research Hospital; Oncology Izmir, , Turkey, 35360
    • Sakarya University Medical School; Medical Oncology Sakarya, , Turkey, 54100
  • Ukraine, KIEV Governorate
    • Municipal Institution Odesa Regional Oncology Dispensary Odesa, KIEV Governorate, Ukraine, 65055
  • Ukraine,
    • CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU Dnipropetrovsk, , Ukraine, 49102
    • Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients Kiev, , Ukraine, 03115
    • National Cancer Institute MOH of Ukraine Kiev, , Ukraine, 36022
    • Treatment and Prevention Institution Volyn Regional Oncology Dispensary Lutsk, , Ukraine, 43018
    • Lviv State Oncological Regional Treatment and Diagnostic Center Lviv, , Ukraine, 79031
  • United Kingdom,
    • Velindre Cancer Centre Cardiff, , United Kingdom, CF14 2TL
    • University Hospital coventry; Oncology Department Coventry, , United Kingdom, CV2 2DX
    • The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit Glasgow, , United Kingdom, G12 0YN
    • Royal Marsden Hospital - London London, , United Kingdom, SW3 6JJ
    • Derriford Hospital Plymouth, , United Kingdom, PL6 8DH
    • Royal Stoke University Hospital Stoke on Trent, , United Kingdom, ST4 6QG
    • Royal Marsden Hospital; Dept of Medical Oncology Sutton, , United Kingdom, SM2 5PT

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03337724
Other Study ID Numbers: 2017-001548-36
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Breast Neoplasms

Triple Negative Breast Neoplasms

Paclitaxel

Albumin-Bound Paclitaxel

Hormones

Next Steps


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ClinicalTrials.gov processed this data on July 18, 2019