A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
NCT ID: NCT03493854
Last Updated: 2024-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2018-06-14
2023-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy
Participants will receive 8 cycles of investigator's choice of neoadjuvant chemotherapy. This will include either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \[G-CSF\] support as needed according to local guidelines) followed by paclitaxel Q1W for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab will be given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants will undergo surgery. Thereafter, participants will receive an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
Cyclophosphamide
Cyclophosphamide 600 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of ddAC Q2W or AC Q3W) for Cycles 1-4.
Doxorubicin
Doxorubicin 60 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of either ddAC Q2W or AC Q3W) for Cycles 1-4.
Docetaxel
As part of one of the two investigator's choices of chemotherapy (AC followed by docetaxel), docetaxel 75 mg/m2 will be administered IV on Day 1 of Cycle 5 and then 100 mg/m2 IV at the discretion of the investigator for Cycles 6-8 (Q3W), if no dose-limiting toxicity occurs.
Paclitaxel
As part of one of the two investigator's choices of chemotherapy (ddAC followed by paclitaxel), paclitaxel 80 mg/m2 will be administered IV QW for 12 weeks.
Pertuzumab IV
Pertuzumab will be administered as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose Q3W.
Trastuzumab IV
Trastuzumab will be administered as an 8-mg/kg IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
Trastuzumab SC
After surgery (from Cycle 9 onwards), participants in Arm A will be allowed to switch from trastuzumab IV to trastuzumab SC, at the discretion of the investigator, in the countries where trastuzumab SC is routinely used. For participants who switch, a fixed dose of 600 mg trastuzumab SC (irrespective of the patient's weight) will be administered in the adjuvant phase.
Surgery
Participants in both cohorts are scheduled to undergo surgery after 8 cycles of neoadjuvant therapy. Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice.
Post-operative Radiotherapy
If indicated, radiotherapy is given after chemotherapy and surgery, during adjuvant HER2-targeted therapy and hormone therapy (for hormone-receptor positive disease).
Hormone Therapy
For hormone receptor positive breast cancer, tamoxifen or aromatase inhibitors will be allowed as adjuvant hormone therapy for postmenopausal participants and with ovarian suppression or ablation for premenopausal participants in countries where it has been registered for this indication. Its use must be consistent with the registered label. Hormone therapy is given after chemotherapy and surgery during adjuvant HER2-targeted therapy.
Arm B: FDC of Pertuzumab and Trastuzumab SC + Chemotherapy
Participants will receive 8 cycles of investigator's choice of neoadjuvant chemotherapy. This will include either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab will be given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants will undergo surgery. Thereafter, participants will receive an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
Cyclophosphamide
Cyclophosphamide 600 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of ddAC Q2W or AC Q3W) for Cycles 1-4.
Doxorubicin
Doxorubicin 60 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of either ddAC Q2W or AC Q3W) for Cycles 1-4.
Docetaxel
As part of one of the two investigator's choices of chemotherapy (AC followed by docetaxel), docetaxel 75 mg/m2 will be administered IV on Day 1 of Cycle 5 and then 100 mg/m2 IV at the discretion of the investigator for Cycles 6-8 (Q3W), if no dose-limiting toxicity occurs.
Paclitaxel
As part of one of the two investigator's choices of chemotherapy (ddAC followed by paclitaxel), paclitaxel 80 mg/m2 will be administered IV QW for 12 weeks.
FDC of Pertuzumab and Trastuzumab SC
The FDC of pertuzumab and trastuzumab will be administered SC at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab Q3W.
Surgery
Participants in both cohorts are scheduled to undergo surgery after 8 cycles of neoadjuvant therapy. Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice.
Post-operative Radiotherapy
If indicated, radiotherapy is given after chemotherapy and surgery, during adjuvant HER2-targeted therapy and hormone therapy (for hormone-receptor positive disease).
Hormone Therapy
For hormone receptor positive breast cancer, tamoxifen or aromatase inhibitors will be allowed as adjuvant hormone therapy for postmenopausal participants and with ovarian suppression or ablation for premenopausal participants in countries where it has been registered for this indication. Its use must be consistent with the registered label. Hormone therapy is given after chemotherapy and surgery during adjuvant HER2-targeted therapy.
Interventions
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Cyclophosphamide
Cyclophosphamide 600 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of ddAC Q2W or AC Q3W) for Cycles 1-4.
Doxorubicin
Doxorubicin 60 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of either ddAC Q2W or AC Q3W) for Cycles 1-4.
Docetaxel
As part of one of the two investigator's choices of chemotherapy (AC followed by docetaxel), docetaxel 75 mg/m2 will be administered IV on Day 1 of Cycle 5 and then 100 mg/m2 IV at the discretion of the investigator for Cycles 6-8 (Q3W), if no dose-limiting toxicity occurs.
Paclitaxel
As part of one of the two investigator's choices of chemotherapy (ddAC followed by paclitaxel), paclitaxel 80 mg/m2 will be administered IV QW for 12 weeks.
Pertuzumab IV
Pertuzumab will be administered as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose Q3W.
FDC of Pertuzumab and Trastuzumab SC
The FDC of pertuzumab and trastuzumab will be administered SC at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab Q3W.
Trastuzumab IV
Trastuzumab will be administered as an 8-mg/kg IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
Trastuzumab SC
After surgery (from Cycle 9 onwards), participants in Arm A will be allowed to switch from trastuzumab IV to trastuzumab SC, at the discretion of the investigator, in the countries where trastuzumab SC is routinely used. For participants who switch, a fixed dose of 600 mg trastuzumab SC (irrespective of the patient's weight) will be administered in the adjuvant phase.
Surgery
Participants in both cohorts are scheduled to undergo surgery after 8 cycles of neoadjuvant therapy. Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice.
Post-operative Radiotherapy
If indicated, radiotherapy is given after chemotherapy and surgery, during adjuvant HER2-targeted therapy and hormone therapy (for hormone-receptor positive disease).
Hormone Therapy
For hormone receptor positive breast cancer, tamoxifen or aromatase inhibitors will be allowed as adjuvant hormone therapy for postmenopausal participants and with ovarian suppression or ablation for premenopausal participants in countries where it has been registered for this indication. Its use must be consistent with the registered label. Hormone therapy is given after chemotherapy and surgery during adjuvant HER2-targeted therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
* Female and male patients with Stage II - IIIC (T2-T4 plus any N, or any T plus N1-N3, M0), locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer
* Primary tumor \>2 cm in diameter, or node-positive disease (clinically or on imaging, and node positivity confirmed with cytology and/or histopathology)
* HER2-positive breast cancer confirmed by a central laboratory prior to study enrollment. HER2-positive status will be determined based on pretreatment breast biopsy material.
* Hormone receptor status of the primary tumor, centrally confirmed
* Patient agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy
* Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for central confirmation of HER2 and hormone receptor status and additional biomarker research
* Baseline left ventricular ejection fraction (LVEF) ≥55% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
* For women of childbearing potential (WOCBP) who are sexually active: agreement to remain abstinent or use one highly effective non-hormonal contraceptive method with a failure rate of \<1% per year, or two effective non-hormonal contraceptive methods during the treatment period and for 7 months after the last dose of HER2-targeted therapy, and agreement to refrain from donating eggs during this same period
* For men: men must remain abstinent or use a condom with a spermicidal product during the treatment period and for 7 months after the last dose of HER2-targeted therapy to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
* A negative serum pregnancy test must be available prior to randomization for WOCBP, unless they have undergone surgical sterilization
* No major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
Exclusion Criteria
* Patients with a history of invasive breast cancer
* Patients with a history of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin
* Patients who have received any previous systemic therapy for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer
* Patients who have a past history of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast
* Patients with high-risk for breast cancer who have received chemo-preventative drugs in the past are not allowed to enter the study
* Patients with multicentric breast cancer, unless all tumors are HER2-positive
* Patients with bilateral breast cancer
* Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes
* Axillary lymph node dissection prior to initiation of neoadjuvant therapy
* Sentinel lymph node biopsy prior to neoadjuvant therapy
* Treatment with any investigational drug within 28 days prior to randomization
* Serious cardiac illness or medical conditions
* Inadequate bone marrow function, renal function or impaired liver function
* Current severe, uncontrolled systemic disease that may interfere with planned treatment
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the last dose of HER2-targeted therapy
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis
* Concurrent, serious, uncontrolled infections, or known infection with HIV
* Known hypersensitivity to study drugs, excipients, and/or murine proteins
* Current chronic daily treatment with corticosteroids
* History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, colon, skin, and/or non-melanoma skin carcinoma
* History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Maryland Oncology Hematology
Rockville, Maryland, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Northwest Medical Specialties
Lakewood, Washington, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, , Argentina
COIBA
Provincia de Buenos Aires, , Argentina
Institut Jules Bordet
Anderlecht, , Belgium
GHdC Site Notre Dame
Charleroi, , Belgium
UZ Antwerpen
Edegem, , Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Clinique Ste-Elisabeth
Namur, , Belgium
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Perola Byington
São Paulo, São Paulo, Brazil
Royal Victoria Hospital
Barrie, Ontario, Canada
Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center
Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Sherbrooke, Quebec, Canada
Masarykuv onkologicky ustav
Brno, , Czechia
Multiscan s.r.o.
Pardubice, , Czechia
ICO Paul Papin; Oncologie Medicale.
Angers, , France
Institut Sainte Catherine
Avignon, , France
CHRU Besançon
Besançon, , France
Institut Bergonie; Oncologie
Bordeaux, , France
Centre Léon Bérard
Lyon, , France
Institut Curie; Oncologie Medicale
Paris, , France
APHP - Hospital Saint Louis
Paris, , France
ICO - Site René Gauducheau
Saint-Herblain, , France
Klinikum Augsburg; Frauenklinik
Augsburg, , Germany
Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie
Bad Nauheim, , Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, , Germany
St. Johannes-Hospital
Dortmund, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, , Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, , Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach, , Germany
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
Stralsund, , Germany
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
Napoli, Campania, Italy
Università degli Studi Federico II; Clinica di Oncologia Medica
Napoli, Campania, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli Venezia Giulia, Italy
Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico
Genoa, Liguria, Italy
ASST DI LECCO; Oncologia Medica
Lecco, Lombardy, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padua, Veneto, Italy
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Gifu University Hospital
Gifu, , Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, , Japan
Hyogo Medical University Hospital
Hyōgo, , Japan
Sagara Hospital
Kagoshima, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Tokai University Hospital
Kanagawa, , Japan
Fukushima Medical University Hospital
Miyagi, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Saitama Medical University International Medical Center
Saitama, , Japan
St. Luke's International Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Iem-Fucam
D.F., Mexico CITY (federal District), Mexico
Centro Médico Zambrano Hellion
Monterrey, Nuevo León, Mexico
Oncologico Potosino
San Luis Potosí City, San Luis Potosí, Mexico
Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie
Bialystok, , Poland
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi
Gliwice, , Poland
Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna
Krakow, , Poland
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
Szczecin, , Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
Warsaw, , Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, , Poland
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Arhangelsk, Russia
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, Russia
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, Sankt-Peterburg, Russia
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan', Tatarstan Republic, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, , Russia
Omsk Region Clinical Oncology Dispensary; 1St Sergical Department
Omsk, , Russia
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Ulsan University Hosiptal
Ulsan, , South Korea
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, Spain
Hospital de Cruces; Servicio de Oncología Médica
Barakaldo, Vizcaya, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, , Spain
China Medical University Hospital; Surgery
Taichung, , Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Dept of Surgery
Taoyuan District, , Taiwan
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
Chiang Mai, , Thailand
Songklanagarind Hospital; Department of Surgery
Songkhla, , Thailand
Municipal Noncommercial Institution Regional Center of Oncology
Kharkiv, Kharkiv Governorate, Ukraine
Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipropetrovsk, , Ukraine
National Cancer Institute MOH of Ukraine
Kiev, , Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Centre
Lviv, , Ukraine
RCI Sumy Regional Clinical Oncological Dispensary
Sumy, , Ukraine
Brighton and Sussex Univ Hosp
Brighton, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
St Georges University Hospitals NHS Foundation Trust
London, , United Kingdom
Christie Hospital NHS Trust
Manchester, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Peterborough City Hospital
Peterborough, , United Kingdom
Countries
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References
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Tan AR, Im SA, Mattar A, Colomer R, Stroyakovskii D, Nowecki Z, De Laurentiis M, Pierga JY, Jung KH, Schem C, Hogea A, Badovinac Crnjevic T, Heeson S, Shivhare M, Kirschbrown WP, Restuccia E, Jackisch C; FeDeriCa study group. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2021 Jan;22(1):85-97. doi: 10.1016/S1470-2045(20)30536-2. Epub 2020 Dec 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004897-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WO40324
Identifier Type: -
Identifier Source: org_study_id
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