IPATunity130: 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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03337724
• Collaborator: (none)
• Enrollment: 580
• Locations: 176
• Arms: 2
• Anticipated Duration (Months): 59.5
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

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 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 580 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: Jan 6, 2018
• Anticipated Primary Completion Date: Dec 22, 2022
• Anticipated Study Completion Date: Dec 22, 2022

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) [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) [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 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) [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) [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 [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 [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) [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 [From randomization up to approximately 53 months]

   Change from baseline in selected vital signs.

9. Changes in Targeted Laboratory Results [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) [Day 1 and Day 15 of Cycle 1, and on Day 15 of Cycle 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy 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

• 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

Locations

	Site	City	State	Country	Postal Code
1	UCSD Moores Cancer Center	La Jolla	California	United States	92093
2	USC Norris Cancer Center	Los Angeles	California	United States	90033
3	USC Norris Cancer Center; USC Oncology Hematology Newport Beach	Newport Beach	California	United States	92663
4	Kaiser Permanente - Oakland	Oakland	California	United States	94611
5	Kaiser Permanente - Roseville	Roseville	California	United States	95661
6	Kaiser Permanente Sacramento Medical Center	Sacramento	California	United States	95814
7	UC Davis; Comprehensive Cancer Center	Sacramento	California	United States	95817
8	Kaiser Permanente - San Francisco (2238 Geary)	San Francisco	California	United States	94115
9	UCSF Comprehensive Cancer Ctr	San Francisco	California	United States	94158
10	K. Permanente - San Jose	San Jose	California	United States	95119
11	Kaiser Permanente - San Leandro	San Leandro	California	United States	94577
12	K. Permanente - Santa Clara	Santa Clara	California	United States	95051
13	Kaiser Permanente - South San Francisco	South San Francisco	California	United States	94080
14	Kaiser Permanente - Vallejo	Vallejo	California	United States	94589
15	K. Permanente - Walnut Creek	Walnut Creek	California	United States	94596
16	Memorial Regional Hospital	Hollywood	Florida	United States	33021
17	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida	United States	33140
18	UF Health Cancer Center at Orlando Health	Orlando	Florida	United States	32824
19	Memorial Hospital West	Pembroke Pines	Florida	United States	33028
20	University of Maryland	Baltimore	Maryland	United States	21201
21	Mercy Medical Center	Baltimore	Maryland	United States	21202
22	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland	United States	21287
23	Memorial Sloan Kettering Cancer Center at Westchester	Harrison	New York	United States	10604
24	Memorial Sloan Kettering	New York	New York	United States	10065
25	West Clinic	Germantown	Tennessee	United States	38138
26	Texas Oncology, P.A.	Dallas	Texas	United States	75246
27	UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy	Dallas	Texas	United States	75390
28	Oncology Consultants PA	Houston	Texas	United States	77030
29	Fundación CENIT para la Investigación en Neurociencias	Buenos Aires		Argentina	C1125ABD
30	Hosp Provincial D. Centenarios; Oncology Dept	Rosario		Argentina	S2002KDS
31	Chris O'Brien Lifehouse	Camperdown	New South Wales	Australia	2050
32	Calvary Mater Newcastle; Medical Oncology	Waratah	New South Wales	Australia	2298
33	Westmead Hospital; Medical Oncology	Wentworthville	New South Wales	Australia	2145
34	Mater Hospital; Cancer Services	South Brisbane	Queensland	Australia	4101
35	Cabrini Medical Centre; Oncology	Malvern	Victoria	Australia	3144
36	Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit	Bull Creek	Western Australia	Australia	6149
37	Cliniques Universitaires St-Luc	Bruxelles		Belgium	1200
38	GHdC Site Notre Dame	Charleroi		Belgium	6000
39	UZ Leuven Gasthuisberg	Leuven		Belgium	3000
40	Santa Casa de Misericordia de Salvador	Salvador	BA	Brazil	40050-410
41	Hospital Araujo Jorge; Departamento de Ginecologia E Mama	Goiania	GO	Brazil	74605-070
42	Hospital do Câncer de Londrina	Londrina	PR	Brazil	86015-520
43	Instituto Nacional de Cancer - INCa; Oncologia	Rio de Janeiro	RJ	Brazil	20560-120
44	Hospital Sao Lucas - PUCRS	Porto Alegre	RS	Brazil	90610-000
45	Hospital Nossa Senhora da Conceicao	Porto Alegre	RS	Brazil	91350-200
46	Faculdade de Medicina do ABC - FMABC	Santo Andre	SP	Brazil	09060-650
47	Hospital Perola Byington	Sao Paulo	SP	Brazil	01317-000
48	British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
49	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
50	Sociedad de Investigaciones Medicas Ltda (SIM)	Temuco		Chile	4810469
51	Clinica CIMCA	San José		Costa Rica	10103
52	ICIMED Instituto de Investigación en Ciencias Médicas	San José		Costa Rica	10108
53	Masarykův onkologický ústav; Klinika komplexní onkologické péče	Brno		Czechia	656 53
54	Fakultni nemocnice Olomouc; Onkologicka klinika	Olomouc		Czechia	779 00
55	CHU Besançon - Hôpital Jean Minjoz	Besançon Cedex		France	25030
56	Polyclinique Bordeaux Nord Aquitaine	Bordeaux		France	33300
57	Centre Georges Francois Leclerc; Oncologie 3	Dijon		France	21079
58	ICM; Medecine B3	Montpellier cedex 5		France	34298
59	Centre Catherine De Sienne	Nantes		France	44202
60	APHP - Hospital Saint Louis	Paris		France	75475
61	Institut Jean Godinot; Oncologie Medicale	Reims CEDEX		France	51056
62	Onkologische Schwerpunktpraxis Kurfürstendamm	Berlin		Germany	10707
63	Praxis für Interdisziplinäre Onkologie und Hämatologie GbR	Freiburg		Germany	79110
64	Universitätsklinikum Hamburg-Eppendorf; Frauenklinik	Hamburg		Germany	20246
65	Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe	Homburg/Saar		Germany	66424
66	Praxis Dr.med. Katja Ziegler-Löhr	Köln		Germany	50679
67	Dres. Andreas Köhler und Roswitha Fuchs	Langen		Germany	63225
68	Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe	Minden		Germany	32429
69	Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie	Recklinghausen		Germany	45659
70	Universitätsfrauen- und Poliklinik am Klinikum Suedstadt	Rostock		Germany	18059
71	Universitätsklinikum Würzburg; Frauenklinik	Würzburg		Germany	97080
72	Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine	Athens		Greece	115 22
73	Agioi Anargyroi; 3Rd Dept. of Medical Oncology	Athens		Greece	145 64
74	Euromedical General Clinic of Thessaloniki; Oncology Department	Thessaloniki		Greece	546 45
75	Orszagos Onkologial Intezet; Onkologiai Osztaly X	Budapest		Hungary	1122
76	Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly	Miskolc		Hungary	3501
77	Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika	Szeged		Hungary	6720
78	Hetenyi Geza County Hospital; Onkologiai Kozpont	Szolnok		Hungary	5004
79	Zala County Hospital ICU	Zalaegerszeg		Hungary	8900
80	Indraprastha Apollo Hospitals	New Delhi	Delhi	India	110076
81	Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology	New Delhi	Delhi	India	110085
82	Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica	Napoli	Campania	Italy	80131
83	Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica	Bologna	Emilia-Romagna	Italy	40138
84	Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica	Aviano	Friuli-Venezia Giulia	Italy	33081
85	Ospedale Santa Maria Annunziata; Oncologia	Bagno a Ripoli	Toscana	Italy	50012
86	IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II	Padova	Veneto	Italy	35128
87	Aichi Cancer Center Hospital	Aichi		Japan	464-8681
88	National Cancer Center Hospital East	Chiba		Japan	277-8577
89	National Hospital Organization Kyushu Cancer Center;Breast Oncology	Fukuoka		Japan	811-1395
90	Fukushima Medical University Hospital	Fukushima		Japan	960-1295
91	Hyogo Medical University Hospital	Hyogo		Japan	663-8501
92	St. Marianna University Hospital	Kanagawa		Japan	216-8511
93	Kanagawa Cancer Center	Kanagawa		Japan	241-8515
94	Tokai University Hospital	Kanagawa		Japan	259-1193
95	Kumamoto Shinto General Hospital	Kumamoto		Japan	862-8655
96	Niigata Cancer Center Hospital	Niigata		Japan	951-8566
97	Okayama University Hospital	Okayama		Japan	700-8558
98	National Hospital Organization Osaka National Hospital	Osaka		Japan	540-0006
99	Kinki University Hospital, Faculty of Medicine; Surgery	Osaka		Japan	589-8511
100	Saitama Cancer Center, Breast Oncology	Saitama		Japan	362-0806
101	Shizuoka Cancer Center	Shizuoka		Japan	411-8777
102	National Cancer Center Hospital	Tokyo		Japan	104-0045
103	St. Luke's International Hospital	Tokyo		Japan	104-8560
104	The Cancer Institute Hospital of JFCR	Tokyo		Japan	135-8550
105	Showa University Hospital; Breast Surgery	Tokyo		Japan	142-8666
106	National Cancer Center	Goyang-si		Korea, Republic of	10408
107	Inha University Hospital	Incheon		Korea, Republic of	22332
108	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13605
109	Seoul National University Hospital	Seoul		Korea, Republic of	03080
110	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
111	Asan Medical Center	Seoul		Korea, Republic of	05505
112	Samsung Medical Center	Seoul		Korea, Republic of	06351
113	Centro Medico Dalinde	Cdmx	Mexico CITY (federal District)	Mexico	06760
114	Centro Médico Zambrano Hellion	Monterrey	Nuevo LEON	Mexico	66278
115	Merida | Investigacion Clinica	Mérida	Yucatan	Mexico	97125
116	Consultorio de Medicina Especializada; Dentro de Condominio San Francisco	Mexico City		Mexico	03100
117	Clinical Hospital; Oncology Department	Bitola		North Macedonia	7000
118	PHI University Clinic of Radiotherapy and Oncology; Breast malignancy	Skopje		North Macedonia	1000
119	PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax	Skopje		North Macedonia	1000
120	Centro Medico Monte Carmelo	Arequipa		Peru	04001
121	Hospital Daniel Alcides Carrion	Callao		Peru	07021
122	Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel	Lima		Peru	15088
123	Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica	Lima		Peru	15102
124	Oncosalud Sac; Oncología	Lima		Peru	41
125	Instituto Nacional de Enfermedades Neoplasicas	Lima		Peru	Lima 34
126	Clinica Ricardo Palma	San Isidro		Peru	Lima 27
127	Instituto Regional de Enfermedades Neoplasicas - IREN Norte	Trujillo		Peru	13014
128	Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.	Gliwice		Poland	44-101
129	Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr	Warszawa		Poland	02-781
130	Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej	Łódź		Poland	93-338
131	Arkhangelsk Regional Clinical Oncology Dispensary	Arkhangelsk	Arhangelsk	Russian Federation	163045
132	Moscow City Oncology Hospital #62	Moscovskaya Oblast	Moskovskaja Oblast	Russian Federation	143423
133	Blokhin Cancer Research Center; Combined Treatment	Moskva	Moskovskaja Oblast	Russian Federation	115478
134	Ivanovo Regional Oncology Dispensary	Ivanovo		Russian Federation	153040
135	SBIH Kaluga Region Clinical Oncology Dispensary	Kaluga		Russian Federation	248007
136	Clinical Oncology Dispensary of Ministry of Health of Tatarstan	Kazan		Russian Federation	420029
137	Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology	Moscow		Russian Federation	125284
138	FSI Rostov research oncological institute of MoH and SD of RF; PAD	Rostov-on-Don		Russian Federation	344037
139	S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)	Saint-Petersburg		Russian Federation	197758
140	National University Hospital; National University Cancer Institute, Singapore (NCIS)	Singapore		Singapore	119228
141	National Cancer Centre; Medical Oncology	Singapore		Singapore	169610
142	Institute of Oncology Ljubljana	Ljubljana		Slovenia	1000
143	Medical Oncology Centre of Rosebank; Oncology	Johannesburg		South Africa	2196
144	Hospital Provincial de Castellon; Servicio de Oncologia	Castellon de La Plana	Castellon	Spain	12002
145	Hospital Universitario Reina Sofia; Servicio de Oncologia	Córdoba	Cordoba	Spain	14004
146	Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia	Santiago de Compostela	LA Coruña	Spain	15706
147	Hospital Universitario Puerta de Hierro; Servicio de Oncologia	Majadahonda	Madrid	Spain	28222
148	Hospital del Mar; Servicio de Oncologia	Barcelona		Spain	08003
149	Vall d´Hebron Institute of Oncology (VHIO), Barcelona	Barcelona		Spain	08035
150	Hospital Clinic Barcelona; Servicio de oncologia	Barcelona		Spain	08036
151	Hospital de Donostia; Servicio de Oncologia	Guipuzcoa		Spain	20014
152	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid		Spain	28034
153	HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia	Madrid		Spain	28050
154	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla		Spain	41013
155	Hospital Clinico Universitario; Oncologia	Valencia		Spain	46010
156	Chi Mei Medical Center Liou Ying Campus	Liuying Township		Taiwan	736
157	Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology	Taipei City		Taiwan	11259
158	VETERANS GENERAL HOSPITAL; Department of General Surgery	Taipei		Taiwan	00112
159	National Taiwan Uni Hospital; General Surgery	Taipei		Taiwan	100
160	Ankara City Hospital	Ankara		Turkey	06490
161	Dicle Uni Medical Faculty; Internal Medicine	Diyarbakir		Turkey	10000
162	Medipol University MF; Oncology Department	Istanbul		Turkey	34214
163	Prof. Dr. Cemil Tascioglu City Hospital; Med Onc	Istanbul		Turkey	34384
164	Katip Celebi University Ataturk Training and Research Hospital; Oncology	Izmir		Turkey	35360
165	Sakarya University Medical School; Medical Oncology	Sakarya		Turkey	54100
166	Chemotherapy SI Dnipropetrovsk MA of MOHU	Dnipropetrovsk		Ukraine	49102
167	Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients	Kiev		Ukraine	03115
168	National Cancer Institute MOH of Ukraine	Kiev		Ukraine	36022
169	Lviv State Oncological Regional Treatment and Diagnostic Center	Lviv		Ukraine	79031
170	Velindre Cancer Centre	Cardiff		United Kingdom	CF14 2TL
171	University Hospital coventry; Oncology Department	Coventry		United Kingdom	CV2 2DX
172	The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit	Glasgow		United Kingdom	G12 0YN
173	Royal Marsden Hospital - London	London		United Kingdom	SW3 6JJ
174	Derriford Hospital	Plymouth		United Kingdom	PL6 8DH
175	Royal Stoke University Hospital	Stoke-on-Trent		United Kingdom	ST4 6QG
176	Royal Marsden Hospital; Dept of Medical Oncology	Sutton		United Kingdom	SM2 5PT

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03337724
• Other Study ID Numbers: CO40016; 2017-001548-36
• First Posted: Nov 9, 2017
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• 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; Paclitaxel

Study Results

No Results Posted as of Aug 17, 2022