MedPath

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

Phase 3
Completed
Conditions
Breast Cancer
Interventions
Registration Number
NCT03337724
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
579
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo + PaclitaxelPlacebo-
Ipatasertib + PaclitaxelPaclitaxel-
Placebo + PaclitaxelPaclitaxel-
Ipatasertib + PaclitaxelIpatasertib-
Primary Outcome Measures
NameTimeMethod
Cohort A: Progression-Free Survival (PFS)From randomization up to 27 months

PFS was defined as the time from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or death from any cause, whichever occurred first, assessed up to 27 months for this outcome measure. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.

Cohort B: PFSFrom randomization up to 24.4 months

PFS was defined as the time from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first, assessed up to 24.4 months for this outcome measure. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Abbreviation used in statistical analysis: PI3K=phosphoinositide 3-kinase and mTOR=mammalian target of rapamycin inhibitor.

Cohort C: PFSFrom enrollment up to 31 months

PFS for Cohort C was defined as the time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first, assessed up to 31 months for this outcome measure. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Secondary Outcome Measures
NameTimeMethod
Cohort C: CBRFrom enrollment up to 31 months

CBR was defined as percentage of participants with an objective response (CR or PR), or SD for at least 24 weeks, as determined by the investigator through the use of RECIST v.1.1 assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages are rounded off to the nearest decimal point.

Cohort A and B: Clinical Benefit Rate (CBR)From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B

CBR was defined as percentage of participants with an objective response (CR or PR), or stable disease (SD) for at least 24 weeks, as determined by the investigator through the use of RECIST v.1.1. assessed up to From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages are rounded off to the nearest decimal point.

Cohort A and B: Objective Response Rate (ORR)From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B

ORR was defined as percentage of participants with partial response (PR) or complete response (CR) on 2 consecutive occasions ≥4 weeks apart as determined by the investigator using RECIST v.1.1, assessed up to 27 months for Cohort A and up to 24.4 months for Cohort B, for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages are rounded off to the nearest decimal point.

Cohort A and B: Duration of Response (DOR)From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B

DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurred first assessed up to 27 months for Cohort A and up to 24.4 months for Cohort B, for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Cohort C: ORRFrom enrollment up to 31 months

ORR was defined as percentage of participants with PR or CR on 2 consecutive occasions ≥4 weeks apart as determined by the investigator using RECIST v.1.1, assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages are rounded off to the nearest decimal point.

Cohort C: DORFrom enrollment up to 31 months

DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurred first, assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Overall Survival (OS)From randomization/ enrollment (Cohort C) up to death from any cause, up to 45 months for Cohort A, up to 46 months for Cohort B and up to 31 months for Cohort C

OS was defined as the time from randomization to death from any cause.

Cohort A and B: Change From Baseline in Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 (cycle length=28 days)

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a cancer-specific instrument with 30 questions covering symptoms, functioning, and health-related quality of life (HRQoL). The participant's assessment of overall HRQoL is assessed by using the last 2 questions (29 and 30) of the instrument, with each of these items based on a 7-point scale (1=very poor to 7=excellent), which are then combined into the GHS/QoL multi-item scale. The scores obtained for each question were averaged into a raw score for the scale, and this raw score for the scale was then subsequently linearly transformed to a scale score of 0 to 100, with a high score indicating better GHS/QoL. Negative change from Baseline values in the GHS/QoL change from baseline analysis indicated deterioration in HRQoL and positive values indicated improvement.

Cohorts A and B:Plasma Concentration of IpatasertibDays 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days)
Cohort C: 1-year Event-free PFS RateFrom enrollment until the occurrence of disease progression or death from any cause, whichever occurred earlier, up to 1 year

PFS was defined as the time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first. Event-free PFS rate was defined as percentage of participants who did not experience any event and survived at 1 year after enrollment. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Percentages are rounded off to the nearest decimal point. As prespecified in the protocol, this outcome measure was applicable only to Cohort C.

Cohort C: Change From Baseline in GHS/HRQoL Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, and 44 (cycle length=28 days)

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions covering symptoms, functioning, and health-related quality of life (HRQoL). The participant's assessment of overall HRQoL is assessed by using the last 2 questions (29 and 30) of the instrument, with each of these items based on a 7-point scale (1=very poor to 7=excellent), which are then combined into the GHS/QoL multi-item scale. The scores obtained for each question were averaged into a raw score for the scale, and this raw score for the scale was then subsequently linearly transformed to a scale score of 0 to 100, with a high score indicating better GHS/QoL. Negative change from Baseline values in the GHS/QoL change from baseline analysis indicated deterioration in HRQoL and positive values indicated improvement.

Number of Participants With Adverse Events (AEs)Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.

Cohorts A and B: Plasma Concentration of G-037720Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days )

G-037720 was a metabolite of ipatasertib.

Cohort C: 1-year Event-free OS RateFrom enrollment up to death from any cause, up to 1 year

OS was defined as the time from enrollment to death from any cause. Event-free OS rate was defined as percentage of participants who did not experience any event and survived at 1 year after enrollment. As prespecified in the protocol, this outcome measure was applicable only to Cohort C. Percentages were rounded off to the nearest decimal.

Cohort B: Time to Deterioration (TTD) in PainBaseline up to 24.4 months

Time to deterioration in GHS/HRQoL was defined as the time from randomization to first observed ≥ 11-point increase from Baseline in pain scale score (Question 9 and 19) in EORTC QLQ-C30 linearly transformed GHS/HRQoL scale score, assessed up 24.4 months for this outcome measure. TTD was planned to be assessed only in cohort with HR+/HER2 - breast cancer participants (Cohort B). Questions 9 and 19 that assessed pain, used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scores were linearly transformed on a scale of 0 to 100, with higher scores indicating increased severity in symptoms.

Cohort C: Plasma Concentration of IpatasertibDays 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days)
Cohort C: Serum Concentration of AtezolizumabDay 1 of Cycle 1: 30 minutes post dose, predose on Day 15 of Cycle 1 and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length=28 days)

As prespecified in the protocol, this outcome measure was applicable only to Cohort C.

Cohort C: Number of Participants With Anti-Drug Antibodies (ADAs) to AtezolizumabUp to 45.5 months

The numbers of ADA-positive participants after drug administration were summarized for participants exposed to atezolizumab. As prespecified in the protocol, this outcome measure was applicable only to Cohort C.

Number of Participants With at Least One Adverse Events of Special Interest (AESI)Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the NCI CTCAE, Version 4.0. AESI include cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law. Suspected transmission of an infectious agent by the study drug, Grade \>= 3 fasting hyperglycemia, hepatotoxicity, diarrhea, rash, ALT/AST elevations. Grade \>= 2 colitis/enterocolitis.

Cohort C: Plasma Concentration of G-037720Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days )

G-037720 was a metabolite of ipatasertib.

Trial Locations

Locations (176)

Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

🇩🇪

Recklinghausen, Germany

Kaiser Permanente - Roseville

🇺🇸

Roseville, California, United States

Kaiser Permanente - South San Francisco

🇺🇸

South San Francisco, California, United States

Memorial Sloan Kettering

🇺🇸

New York, New York, United States

Mount Sinai Comprehensive Cancer Center

🇺🇸

Miami Beach, Florida, United States

Kaiser Permanente - Oakland

🇺🇸

Oakland, California, United States

Fundación CENIT para la Investigación en Neurociencias

🇦🇷

Buenos Aires, Argentina

UZ Leuven Gasthuisberg

🇧🇪

Leuven, Belgium

CHU Besançon - Hôpital Jean Minjoz

🇫🇷

Besançon Cedex, France

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

🇩🇪

Freiburg, Germany

Polyclinique Bordeaux Nord Aquitaine

🇫🇷

Bordeaux, France

UCSD Moores Cancer Center

🇺🇸

La Jolla, California, United States

West Clinic

🇺🇸

Germantown, Tennessee, United States

Agioi Anargyroi; 3Rd Dept. of Medical Oncology

🇬🇷

Athens, Greece

National Cancer Center Hospital East

🇯🇵

Chiba, Japan

Fukushima Medical University Hospital

🇯🇵

Fukushima, Japan

Dres. Andreas Köhler und Roswitha Fuchs

🇩🇪

Langen, Germany

Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

🇩🇪

Rostock, Germany

Santa Casa de Misericordia de Salvador

🇧🇷

Salvador, BA, Brazil

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

🇨🇿

Brno, Czechia

Universitätsklinikum Würzburg; Frauenklinik

🇩🇪

Würzburg, Germany

Praxis Dr.med. Katja Ziegler-Löhr

🇩🇪

Köln, Germany

Hosp Provincial D. Centenarios; Oncology Dept

🇦🇷

Rosario, Argentina

Cliniques Universitaires St-Luc

🇧🇪

Bruxelles, Belgium

Indraprastha Apollo Hospitals

🇮🇳

New Delhi, Delhi, India

Jewish General Hospital

🇨🇦

Montreal, Quebec, Canada

Sociedad de Investigaciones Medicas Ltda (SIM)

🇨🇱

Temuco, Chile

ICIMED Instituto de Investigación en Ciencias Médicas

🇨🇷

San José, Costa Rica

Cabrini Medical Centre; Oncology

🇦🇺

Malvern, Victoria, Australia

GHdC Site Notre Dame

🇧🇪

Charleroi, Belgium

Hospital Nossa Senhora da Conceicao

🇧🇷

Porto Alegre, RS, Brazil

Severance Hospital, Yonsei University Health System

🇰🇷

Seoul, Korea, Republic of

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

🇬🇷

Athens, Greece

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

🇭🇺

Szeged, Hungary

National Hospital Organization Osaka National Hospital

🇯🇵

Osaka, Japan

The Cancer Institute Hospital of JFCR

🇯🇵

Tokyo, Japan

Centro Médico Zambrano Hellion

🇲🇽

Monterrey, Nuevo LEON, Mexico

Centro Medico Monte Carmelo

🇵🇪

Arequipa, Peru

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

🇵🇱

?ód?, Poland

Hospital Provincial de Castellon; Servicio de Oncologia

🇪🇸

Castellon de La Plana, Castellon, Spain

Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

🇩🇪

Homburg/Saar, Germany

Aichi Cancer Center Hospital

🇯🇵

Aichi, Japan

Tokai University Hospital

🇯🇵

Kanagawa, Japan

Saitama Cancer Center, Breast Oncology

🇯🇵

Saitama, Japan

Inha University Hospital

🇰🇷

Incheon, Korea, Republic of

Orszagos Onkologial Intezet; Onkologiai Osztaly X

🇭🇺

Budapest, Hungary

Hyogo Medical University Hospital

🇯🇵

Hyogo, Japan

Niigata Cancer Center Hospital

🇯🇵

Niigata, Japan

Okayama University Hospital

🇯🇵

Okayama, Japan

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

🇵🇪

Lima, Peru

Oncosalud Sac; Oncología

🇵🇪

Lima, Peru

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

🇵🇱

Warszawa, Poland

SBIH Kaluga Region Clinical Oncology Dispensary

🇷🇺

Kaluga, Russian Federation

National Cancer Centre; Medical Oncology

🇸🇬

Singapore, Singapore

Hospital Clinic Barcelona; Servicio de oncologia

🇪🇸

Barcelona, Spain

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

🇵🇪

Lima, Peru

Clinica Ricardo Palma

🇵🇪

San Isidro, Peru

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

🇷🇺

Moscow, Moskovskaja Oblast, Russian Federation

National Cancer Institute MOH of Ukraine

🇺🇦

Kiev, Ukraine

Seoul National University Bundang Hospital

🇰🇷

Seongnam-si, Korea, Republic of

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

🇪🇸

Sevilla, Spain

Katip Celebi University Ataturk Training and Research Hospital; Oncology

🇹🇷

Izmir, Turkey

Royal Stoke University Hospital

🇬🇧

Stoke-on-Trent, United Kingdom

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

🇪🇸

Santiago de Compostela, LA Coruña, Spain

Moscow City Oncology Hospital #62

🇷🇺

Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation

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

🇷🇺

Rostov-on-Don, Rostov, Russian Federation

Hospital Universitario Reina Sofia; Servicio de Oncologia

🇪🇸

Córdoba, Cordoba, Spain

Dicle Uni Medical Faculty; Internal Medicine

🇹🇷

Diyarbakir, Turkey

University Hospital coventry; Oncology Department

🇬🇧

Coventry, United Kingdom

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

🇪🇸

Majadahonda, Madrid, Spain

Hospital del Mar; Servicio de Oncologia

🇪🇸

Barcelona, Spain

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

🇪🇸

Madrid, Spain

Medical Oncology Centre of Rosebank; Oncology

🇿🇦

Johannesburg, South Africa

Chemotherapy SI Dnipropetrovsk MA of MOHU

🇺🇦

Dnipropetrovsk, Ukraine

Medipol University Medical Faculty; Oncology Department

🇹🇷

Istanbul, Turkey

National Taiwan Uni Hospital; General Surgery

🇨🇳

Taipei, Taiwan

Sakarya University Medical School; Medical Oncology

🇹🇷

Sakarya, Turkey

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

🇬🇧

Glasgow, United Kingdom

Royal Marsden Hospital; Dept of Medical Oncology

🇬🇧

Sutton, United Kingdom

Derriford Hospital

🇬🇧

Plymouth, United Kingdom

K. Permanente - Santa Clara

🇺🇸

Santa Clara, California, United States

K. Permanente - Walnut Creek

🇺🇸

Walnut Creek, California, United States

Calvary Mater Newcastle; Medical Oncology

🇦🇺

Waratah, New South Wales, Australia

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

🇨🇦

Vancouver, British Columbia, Canada

Clinica CIMCA

🇨🇷

San José, Costa Rica

Fakultni nemocnice Olomouc; Onkologicka klinika

🇨🇿

Olomouc, Czechia

APHP - Hospital Saint Louis

🇫🇷

Paris, France

Institut Jean Godinot; Oncologie Medicale

🇫🇷

Reims CEDEX, France

Onkologische Schwerpunktpraxis Kurfürstendamm

🇩🇪

Berlin, Germany

Euromedical General Clinic of Thessaloniki; Oncology Department

🇬🇷

Thessaloniki, Greece

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

🇩🇪

Minden, Germany

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

🇭🇺

Miskolc, Hungary

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

🇮🇹

Bologna, Emilia-Romagna, Italy

Ospedale Santa Maria Annunziata; Oncologia

🇮🇹

Bagno a Ripoli, Toscana, Italy

National Hospital Organization Kyushu Cancer Center;Breast Oncology

🇯🇵

Fukuoka, Japan

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Merida | Investigacion Clinica

🇲🇽

Mérida, Yucatan, Mexico

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

🇲🇰

Skopje, North Macedonia

Instituto Regional de Enfermedades Neoplasicas - IREN Norte

🇵🇪

Trujillo, Peru

Blokhin Cancer Research Center; Combined Treatment

🇷🇺

Moskva, Moskovskaja Oblast, Russian Federation

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

🇷🇺

Kazan, Tatarstan, Russian Federation

Institute of Oncology Ljubljana

🇸🇮

Ljubljana, Slovenia

Hospital de Donostia; Servicio de Oncologia

🇪🇸

Guipuzcoa, Spain

VETERANS GENERAL HOSPITAL; Department of General Surgery

🇨🇳

Taipei, Taiwan

Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

🇹🇷

Istanbul, Turkey

Velindre Cancer Centre

🇬🇧

Cardiff, United Kingdom

Lviv State Oncological Regional Treatment and Diagnostic Center

🇺🇦

Lviv, Ukraine

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

🇮🇳

New Delhi, Delhi, India

Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

🇦🇺

Bull Creek, Western Australia, Australia

Centre Georges Francois Leclerc; Oncologie 3

🇫🇷

Dijon, France

ICM; Medecine B3

🇫🇷

Montpellier cedex 5, France

Centre Catherine De Sienne

🇫🇷

Nantes, France

Ankara Bilkent City Hospital

🇹🇷

Ankara, Turkey

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

🇮🇹

Aviano, Friuli-Venezia Giulia, Italy

Royal Marsden Hospital - London

🇬🇧

London, United Kingdom

Hospital Araujo Jorge; Departamento de Ginecologia E Mama

🇧🇷

Goiania, GO, Brazil

Instituto Nacional de Cancer - INCa; Oncologia

🇧🇷

Rio de Janeiro, RJ, Brazil

Hospital Sao Lucas - PUCRS

🇧🇷

Porto Alegre, RS, Brazil

Faculdade de Medicina do ABC - FMABC

🇧🇷

Santo Andre, SP, Brazil

Hospital Perola Byington

🇧🇷

Sao Paulo, SP, Brazil

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

🇪🇸

Barcelona, Spain

Hospital Ramon y Cajal; Servicio de Oncologia

🇪🇸

Madrid, Spain

Hospital Clinico Universitario; Oncologia

🇪🇸

Valencia, Spain

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Zala County Hospital ICU

🇭🇺

Zalaegerszeg, Hungary

Kanagawa Cancer Center

🇯🇵

Kanagawa, Japan

Kinki University Hospital, Faculty of Medicine; Surgery

🇯🇵

Osaka, Japan

Shizuoka Cancer Center

🇯🇵

Shizuoka, Japan

National Cancer Center Hospital

🇯🇵

Tokyo, Japan

Showa University Hospital; Breast Surgery

🇯🇵

Tokyo, Japan

Memorial Sloan Kettering Cancer Center at Westchester

🇺🇸

Harrison, New York, United States

Hospital do Câncer de Londrina

🇧🇷

Londrina, PR, Brazil

Universitätsklinikum Hamburg-Eppendorf; Frauenklinik

🇩🇪

Hamburg, Germany

Hetenyi Geza County Hospital; Onkologiai Kozpont

🇭🇺

Szolnok, Hungary

CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO

🇲🇽

Mexico City, Mexico

PHI University Clinic of Radiotherapy and Oncology; Breast malignancy

🇲🇰

Skopje, North Macedonia

Instituto Nacional de Enfermedades Neoplasicas

🇵🇪

Lima, Peru

National Cancer Center

🇰🇷

Goyang-si, Korea, Republic of

St. Marianna University Hospital

🇯🇵

Kanagawa, Japan

Kumamoto Shinto General Hospital

🇯🇵

Kumamoto, Japan

Centro Medico Dalinde

🇲🇽

Cdmx, Mexico CITY (federal District), Mexico

Hospital Daniel Alcides Carrion

🇵🇪

Callao, Peru

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

🇵🇱

Gliwice, Poland

Ivanovo Regional Oncology Dispensary

🇷🇺

Ivanovo, Russian Federation

Clinical Hospital; Oncology Department

🇲🇰

Bitola, North Macedonia

St. Luke's International Hospital

🇯🇵

Tokyo, Japan

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

🇸🇬

Singapore, Singapore

Arkhangelsk Regional Clinical Oncology Dispensary

🇷🇺

Arkhangelsk, Arhangelsk, Russian Federation

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

🇷🇺

Saint-Petersburg, Sankt Petersburg, Russian Federation

Chi Mei Medical Center Liou Ying Campus

🇨🇳

Liuying Township, Taiwan

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

🇨🇳

Taipei City, Taiwan

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

🇺🇦

Kiev, Ukraine

USC Norris Cancer Center

🇺🇸

Los Angeles, California, United States

USC Norris Cancer Center; USC Oncology Hematology Newport Beach

🇺🇸

Newport Beach, California, United States

Kaiser Permanente - San Francisco (2238 Geary)

🇺🇸

San Francisco, California, United States

UCSF Comprehensive Cancer Ctr

🇺🇸

San Francisco, California, United States

UC Davis; Comprehensive Cancer Center

🇺🇸

Sacramento, California, United States

Kaiser Permanente Sacramento Medical Center

🇺🇸

Sacramento, California, United States

Kaiser Permanente - San Leandro

🇺🇸

San Leandro, California, United States

Texas Oncology, P.A.

🇺🇸

Dallas, Texas, United States

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

🇺🇸

Dallas, Texas, United States

Kaiser Permanente - Vallejo

🇺🇸

Vallejo, California, United States

Memorial Regional Hospital

🇺🇸

Hollywood, Florida, United States

UF Health Cancer Center at Orlando Health

🇺🇸

Orlando, Florida, United States

Memorial Hospital West

🇺🇸

Pembroke Pines, Florida, United States

University of Maryland

🇺🇸

Baltimore, Maryland, United States

Mercy Medical Center

🇺🇸

Baltimore, Maryland, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

🇺🇸

Baltimore, Maryland, United States

Oncology Consultants PA

🇺🇸

Houston, Texas, United States

Chris O'Brien Lifehouse

🇦🇺

Camperdown, New South Wales, Australia

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

🇮🇹

Napoli, Campania, Italy

K. Permanente - San Jose

🇺🇸

San Jose, California, United States

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

🇮🇹

Padova, Veneto, Italy

Westmead Hospital; Medical Oncology

🇦🇺

Wentworthville, New South Wales, Australia

Mater Hospital; Cancer Services

🇦🇺

South Brisbane, Queensland, Australia

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