Clinical trial NCT05563220: Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Official title: A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Metastatic Breast Cancer
Keywords: breast cancer
Lead sponsor: Stemline Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

Detailed description: This is a multicenter, Phase 1b/2 trial. The Phase 1b aims at selecting the RP2D dose, defined as a dose that is associated with less than 33% of patients experiencing a DLT of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib, that is, ≤1 patient experiencing a DLT out of 6 DLT evaluable patients. For each combination, this phase will have between 1 and 3 cohorts of 6 DLT-evaluable patients each. The total number of DLT-evaluable patients in all the combinations will vary between 24 and 72.

The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

The treatment arms will be:

* Arm A: 50 patients: elacestrant with alpelisib;
* Arm B: 50 patients: elacestrant with everolimus;
* Arm C: 60 patients (30 patients in each combination): elacestrant with either abemaciclib or ribociclib;
* Arm D: 90 patients (30 patients in each combination): elacestrant with either palbociclib, abemaciclib, or ribociclib
* Arm E: 60 patients: elacestrant with capivasertib

Phase 1b will have a total of 90 patients, while Phase 2 will have 310 patients for all treatment arm combinations.

Eligibility criteria: Inclusion Criteria:

1. Patient has signed the informed consent before all study specific activities are conducted.
2. Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female patients may be of any menopausal status.

   * Postmenopausal status is defined by:

     1. Age ≥60 years
     2. Age \<60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or a follicle-stimulating hormone (FSH) value \>40 mIU/mL and an estradiol value\<40 pg/mL (140 pmol/L) or in postmenopausal ranges per local reference ranges
     3. Documentation of prior surgical sterilization (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, at least 1 month before first dose of trial therapy).
   * Premenopausal and perimenopausal women (who do not fit postmenopausal criteria) and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist initiated at least 4 weeks before the start of trial therapy and are planning to continue LHRH agonist treatment during the study treatment.
   * For perimenopausal women to be considered of non-childbearing potential, FSH levels must be \>40 mIU/ml.
3. Histopathological or cytological confirmed ER+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists(CAP) guidelines (Allison et al, 2020, Wolff et al, 2018). Note: In the context of this trial, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without PGR positivity. .
4. At least 1 not previously irradiated measurable lesion as per RECIST version 1.1 and/or at least 1 lytic or mixed (lytic +sclerotic) bone lesion with identifiable soft tissue components meeting the definition of measurability by RECIST version 1.1 that can be evaluated by CT or MRI; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible.
5. ECOG performance status of 0 or 1.
6. Patient has adequate bone marrow and organ function, as defined by the following laboratory values:

   1. Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L
   2. Platelets ≥100 × 10\^9/L
   3. Hemoglobin ≥9.0 g/dL
   4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE grade ≤1
   5. Creatinine is ≤ 1.5 x ULN or if creatinine is \> 1.5 x ULN, then creatinine clearance must be ≥50 mL/min based on the Cockcroft-Gault formula. Note: C-G formula:

      * Creatinine clearance (male) = (\[140-age in years\] × weight in kg)/ (\[serum creatinine in mg/dL\] × 72)
      * Creatinine clearance (female) = (0.85 × \[140-age in years\] × weight in kg)/ (\[serum creatinine in mg/dL\] × 72)
   6. Serum albumin ≥3.0 g/dL (≥30 g/L)
   7. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN. If the patient has liver metastases, ALT and AST ≤ 5 × ULN
   8. Total serum bilirubin \<1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.

Exclusion Criteria:

1. Active or newly diagnosed CNS metastases, including meningeal carcinomatosis. Note: Patients with stable brain or subdural metastases are allowed if the patient has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for management of brain metastasis for at least 4 weeks before starting treatment in this study. The dose must be ≤2.0 mg/day of dexamethasone or equivalent. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
2. Patients with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \>50%.
3. Prior chemotherapy or elacestrant in the advanced/metastatic setting.
4. Patients with known germline BRCA mutation without prior treatment with a PARP inhibitor before study entry.
5. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERM), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysis-targeting chimeras (PROTACs), in the metastatic setting. Prior treatment with fulvestrant is not exclusionary as it is an approved medication.
6. Patient has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy. Other malignancies with low risk of recurrence may be considered eligible with Sponsor approval.
7. Uncontrolled significant active infections. • Patients with HBV and/or HCV infection must have undetectable viral load during screening.

   • Patients known to be HIV+ are allowed if they have undetectable viral load at baseline.
8. Documented pneumonitis/ILD prior to Cycle 1 Day 1.
9. Major surgery within 28 days before starting trial therapy.
10. Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impact the absorption of the study drug.
11. Known intolerance to elacestrant or any of its excipients.
12. Pregnant and breast-feeding women are excluded from the study. In addition, women of childbearing potential are excluded who:

    • Within 28 days before starting trial therapy, did not use a highly effective method of contraception.

    • Do not agree to use a highly effective method of contraception (Appendix F) or abstain from heterosexual intercourse throughout the entire study period and for 120 days after trial therapy discontinuation.
13. Men or women who do not agree to abstain from donating sperm or ova, or to use a highly effective method of contraception, during the course of the treatment period and for 120 days after the last dose of study treatment.
14. Patient is currently receiving or received any of the following medications prior to first dose of trial therapy:

    • Anti-cancer therapy within 14 days (28 days for anticancer antibody based treatment) or 5 half-lives, whichever is shorter.

    Please note: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2).

    • Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 within 14 days or 5 half-lives, whichever is shorter, (refer to http://medicine.iupui.edu/clinpharm/ddis/ or https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers).

    • Herbal preparations/medications within 7 days. These include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.

    • Vaccination, including but not limited to vaccination against COVID-19, during the 7 days prior to randomization.
15. Evidence of ongoing alcohol or drug abuse as assessed by the investigator.
16. Any severe medical or psychiatric condition that, in the Investigator's opinion, would preclude the patient's participation in a clinical study.

Additional Eligibility for the Alpelisib Combination (Phase 1b and Arm A)

Inclusion:

In general, the SmPC of the respective combination drug should be consulted for instructions/restrictions with respect to interactions with concomitant medications.

1. PIK3CA mutation by local laboratory assessment.
2. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Exclusion:

1. Prior therapy with alpelisib or any other PI3K inhibitor.
2. Type 1 diabetes or uncontrolled type 2 diabetes (fasting plasma glucose level of \>140 mg/dL \[7.7 mmol/L\], or glycosylated hemoglobin \[HbA1c\] level of \>6.4%).
3. Known intolerance to alpelisib or any of its excipients.
4. Patient is currently receiving or received drugs known to be a BCRP inhibitor within 14 days or 5 half-lives, whichever is shorter, prior to first dose of trial therapy
5. Patient has ongoing osteonecrosis of the jaw from previous or concurrent treatment with bisphosphonates or denosumab

Additional Eligibility for the Everolimus Combination (Phase 1b and Arm B)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Exclusion:

1. Prior therapy with everolimus.
2. Known intolerance to everolimus or any of its excipients.

Additional Eligibility for the Abemaciclib Combination (Arm C)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Exclusion:

1. Prior therapy with abemaciclib in the advanced or metastatic setting. Adjuvant therapy with abemaciclib is exclusionary if the patient relapsed within the past 12 months.
2. Known intolerance to abemaciclib or any of its excipients.

Additional Eligibility for the Ribociclib Combination (Phase 1b and Arm C)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Exclusion:

1. Prior therapy with ribociclib in the metastatic setting. Prior adjuvant therapy with ribociclib is also exclusionary if the patient relapsed within the past 12 months.
2. Known intolerance to ribociclib or any of its excipients.
3. QTcF values ≥450 msec.
4. Patients who already have or who are at significant risk of developing QTc prolongation, including patients with:

   * Long QT syndrome
   * Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias
   * Electrolyte abnormalities
5. Patient is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy.

Additional Eligibility for the Palbociclib Combination (Phase 1b)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Exclusion:

1. Prior therapy with palbociclib in the metastatic setting.
2. Known intolerance to palbociclib or any of its excipients

Additional Eligibility for the Palbociclib Combination (Arm D)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting.

Exclusion:

1. Prior therapy with a CDK4/6i in the metastatic setting.
2. Known intolerance to palbociclib or any of its excipients.

Additional Eligibility for the Abemaciclib Combination (Arm D)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting.

Exclusion:

1. Prior therapy with any CDK4/6i in the metastatic setting.
2. Known intolerance to abemaciclib or any of its excipients.

Additional Eligibility for Ribociclib Combination (Arm D)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting.

Exclusion:

1. Prior therapy with a CDK4/6i in the advanced or metastatic setting.
2. Known intolerance to ribociclib or any of its excipients.
3. QTcF values ≥450 msec.
4. Patients who already have or who are at significant risk of developing QTc prolongation, including patients with:

   * Long QT syndrome
   * Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias
   * Electrolyte abnormalities
5. Patient is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy.

Primary outcomes:
measure: Number of DLTs observed during the first cycle
timeFrame: 28 days
measure: Estimation of PFS rate at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Standard PK parameters including AUC0-tau, Cmax, Tmax, and Ctrough
timeFrame: 36 months
measure: Overall Response Rate
timeFrame: 36 months
measure: Duration of Response
timeFrame: 36 months
measure: Clinical Benefit Rate
timeFrame: 36 months
measure: Progression-free survival
timeFrame: 36 months
measure: Overall Survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Dothan Hematology and Oncology
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Arcadia
country: United States
facility: OPN Healthcare (Arcadia Location)
state: California
city: Glendale
country: United States
facility: Glendale Adventist
state: California
city: Los Alamitos
country: United States
facility: OPN Healthcare (Los Alamitos Location)
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Los Angeles
country: United States
facility: UCLA UCLA Hem/Onc - Clinical Research Unit
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Whittier
country: United States
facility: TOI Clinical Research
state: California
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: New Haven
country: United States
facility: Yale School Of Medicine - Smilow Cancer Hospital - Breast Center
state: Connecticut
city: Washington
country: United States
facility: George Washington Cancer Center
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Advent Health (Florida Hospital) - Altamonte Springs
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology
state: Florida
city: Cumming
country: United States
facility: Northside Hospital Atlanta Cancer Care
state: Georgia
city: Chicago
country: United States
facility: Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Merriam
country: United States
facility: MD Alliance for Multispecialty Research, LLC
state: Kansas
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: New Brunswick
country: United States
facility: Cooperman Barnabas Medical Center
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Port Jefferson Station
country: United States
facility: New York Cancer and Blood Specialists
state: New York
city: Providence
country: United States
facility: W&IH of RI Breast Health Center of Women and Infants Hospital of Rhode Island
state: Rhode Island
city: Nashville
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center Texas
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Spokane Valley
country: United States
facility: Cancer Care Northwest
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties (Nwms) - Puyallup - Medical Oncology (Rainier Hematology-Oncology)/Exigent Research Network; LLC
state: Washington
city: Madison
country: United States
facility: University of WI - Carbone Cancer Center (Phase II only)
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Centro Medico Austral
city: Buenos Aires
country: Argentina
facility: Hospital Britanico De Buenos Aires
city: Cordoba
country: Argentina
facility: Cemaic - Centro De Especialidades Medicas Ambulatorias E Investigacion Clinica
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (Cori)
city: Sydney
country: Australia
facility: Macquarie University
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Site Notre Dame
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen (Uz) Leuven - Campus Gasthuisberg - Multidisciplinair Borstcentrum (Multidisciplinary Breast Center) (Mbc)
city: Sint-Niklaas
country: Belgium
facility: Algemeen Ziekenhuis Nikolaas; VITAZ; Oncologie Klinisch Studiecentrum
city: Goiania
country: Brazil
facility: ACCG - Hospital Araujo Jorge
city: Itajai
country: Brazil
facility: Clinica Neoplasias Litoral
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia; Hematologia; Ensino e Pesquisa - Hospital Mae de Deus/AESC
city: Sao Paulo
country: Brazil
facility: Hospital Sirio-Libanes (HSL) - Centro De Oncologia - Sao Paulo
city: Hořovice
country: Czechia
facility: Nemocnice Horovice Hospital
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Lyon
country: France
facility: Centre Hospitalier Lyon SUD- HCL
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier
city: Rouen
country: France
facility: Centre de Cancérologie du Grand Montpellier
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire (Chu) De Toulouse - Institut Universitaire Du Cancer De Toulouse-Oncopole (Iuct-Oncopole) (Institut Claudius Regaud)
city: Villejuif
country: France
facility: Institut Gustave-Roussy-Umr 981
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: Technischen Universitaet Muenchen (TUM), Klinikum Rechts der Isar
state: Bayern
city: Dresden
country: Germany
facility: Universitatskinikum Carl Gustav Carus Dresden
state: Sachsen
city: Bottrop
country: Germany
facility: Marienhospital Bottrop
city: Dresden
country: Germany
facility: Universitatskinikum Carl Gustav Carus Dresden
city: Essen
country: Germany
facility: Kliniken Essen-Mitte (KEM)
city: Kassel
country: Germany
facility: Gesundheit Nordhessen Klinikum Kassel
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Klinikai Kozpont - Onkologiai Intezet
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Ashdod
country: Israel
facility: Samson Assuta Ashdod University Hospital - The Institute of Oncology
city: Haifa
country: Israel
facility: Rambam Heath
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petah Tikva
country: Israel
facility: Davidoff Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center; Center Israel
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Cremona
country: Italy
facility: Azienda Ospedaliera "Istituti Ospitalieri" Di Cremona
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia (IEO)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori "Fondazione PASCALE"
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini - Azienda Unita Sanitaria Locale Della Romagna
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea - Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Libramont
country: Luxembourg
facility: Centre Hospitalier De L'Ardenne
city: Warszawa
country: Poland
facility: Klinika Onkologii; Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
state: Mazowieckie
city: Konin
country: Poland
facility: Przychodnia Lekarska "Komed" Roman Karaszewski
city: Poznań
country: Poland
facility: Med-Polonia Sp. Z o.o.
city: Łódź
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: IOB Madrd Institute of Oncology Hospital Beata Maria Ana de Jesus
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Pozuelo de Alarcon
country: Spain
facility: NEXT Madrid
city: Valencia
country: Spain
facility: Fundacion Instituto Valeciano De Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau De Vilanova
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Oncology Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital, Bilkent Campus, Universiteler Mh. (old: Ankara Yildirim Beyazit Universitesi)
city: Liverpool
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Hospital
city: London
country: United Kingdom
facility: North Middlesex University Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK; Ltd
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust; The London Clinic - Main Hospital
Study officials:
References: