Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.

NCT ID: NCT03161353

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 377 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-26
• Study Completion Date: 2026-11-01

Brief Summary

The study assess the early metabolic effects of neoadjuvant treatment with trastuzumab and pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their predictive value for pathologic complete response (pCR) in the breast and axilla.

And also assess 3-year invasive disease-free survival (iDFS) in patients with HER2-positive (HER: human epidermal receptor) breast cancer treated with neoadjuvant trastuzumab and pertuzumab (± endocrine therapy) using a FDG-PET response-adapted strategy.

Detailed Description

Investigational Medicinal Products (IMPs) will be trastuzumab and pertuzumab, carboplatin, and docetaxel, as well as all endocrine therapy drugs to be administered according to HR status (hormone receptor). For cohort C, trastuzumab SC (subcutaneous) and pertuzumab IV will be IMPs until a maximum of 18 cycles.

Patients will be randomly assigned in a 1:4 ratio, with a randomization stratified by HR status to receive trastuzumab and pertuzumab with docetaxel and carboplatin (cohort A) or trastuzumab and pertuzumab ± endocrine therapy according to HR status (cohort B).

A F-FDG PET/CT will be performed at baseline (total body) and after 2 cycles of neoadjuvant therapy. Central review of F-FDG PET/CT will be mandatory. Patients allocated into cohort A will continue with the same treatment for a total of six cycles regardless of 18F-FDG PET/CT results. Patients enrolled into cohort B showing at least 40% reduction of the SUVmax of F-FDG PET/CT respect to baseline (PET responders) will continue with the same treatment for a total of 8 cycles. PET-non responders patients will also receive neoadjuvant chemotherapy based on six cycles of docetaxel and carboplatin concurrently with trastuzumab and pertuzumab for all cycles.

Following surgery, cohort B/PET responders patients who do not achieve a pCR will additionally receive six cycles of docetaxel and carboplatin concurrently with trastuzumab and pertuzumab for all cycles. Moreover, all patients from cohorts A/B must complete 18 cycles of trastuzumab and pertuzumab, along with adjuvant endocrine therapy and radiotherapy according to HR status (hormone receptor) and institutional practices, respectively.

An additional exploratory cohort (cohort C) will include patients with evidence of subclinic M1 at baseline 18F-FDG PET/CT, but not previously detected by routine clinical assessment. These patients will receive trastuzumab and pertuzumab with docetaxel and carboplatin for a total of six cycles. After first six cycles, these patients will receive trastuzumab and pertuzumab ± endocrine.therapy according to HR status for at least 12 additional cycles after surgery (only if surgery is performed). According to institutional practices, it will be allowed to continue treatment with trastuzumab and pertuzumab, along endocrine therapy on the basis of HR status, as maintenance therapy until disease progression or unacceptable toxicity.

A sub-set of 42 patients (35 patients from cohort A and 7 patients from cohort B) from 5 sites in Spain are participating in the LINGain sub-study "Prospective evaluation of predictive/prognostic immunogenicity biomarkers for target therapy in HER2-positive early breast cancer within the PHERGain study" : Hospital General de Valencia, Hospital Clínico Universitario de Valencia, IVO, Hospital La Fe and Hospital Arnau de Vilanova.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

Cohorts A/B if there is no evidence of subclinic M1 assessed by 18F-FDG PET/CT at screening. Interventional: Perjeta+Herceptin+Carboplatin+Docetaxel (during 4 cycles):

PET responders or not responders after surgery: Continue with Perjeta+Herceptin+ Endocrine therapy (tamoxifen or letrozole) during 12 cycles

A sub-set of 42 patients (35 patients from cohort A and 7 patients from cohort B) from 5 sites in Spain are participating in the LINGain sub-study "Prospective evaluation of predictive/prognostic immunogenicity biomarkers for target therapy in HER2-positive early breast cancer within the PHERGain study".

Group Type: EXPERIMENTAL

Perjeta

Intervention Type: DRUG

All patients will receive Perjeta® as an IV infusion on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent 3-week cycle. Perjeta® IV should be administered 60 minutes after the end of Herceptin® SC (subcutaneous) administration. An observation period of 30-60 minutes is recommended after each Perjeta® infusion.

Herceptin

Intervention Type: DRUG

All patients will receive a fixed dose of 600 mg, irrespective of the patient's weight, will be administered throughout the treatment phase. All doses of Herceptin® SC will be administered as an SC injection into the thigh by a trained health care professional over a period of 2-5 minutes. No loading dose is required with Herceptin® SC.

Docetaxel

Intervention Type: DRUG

Docetaxel will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC, Perjeta® IV, and carboplatin

Carboplatin

Intervention Type: DRUG

Carboplatin will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC and Perjeta® IV.

Letrozole

Intervention Type: DRUG

Postmenopausal women will receive letrozole 2.5 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Tamoxifen

Intervention Type: DRUG

Premenopausal women will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Male patients will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Cohort B

Cohorts A/B if there is no evidence of subclinic M1 assessed by 18F-FDG PET/CT at screening. Interventional: Perjeta+Herceptin+Endocrine therapy (tamoxifen or letrozole) during 2 cycles.

• PET responders: Perjeta+Herceptin+Endocrine therapy during 6 cycles. -Complete response: continue with Perjeta+Herceptin+ Endocrine therapy during 10 cycles -Non-complete response: Perjeta+Herceptin+ Carboplatin+ Docetaxel during 6 cycles and Perjeta+Herceptin+Endocrine therapy during 4 cycles.
• PET non-responders: Perjeta+Herceptin+Carboplatin+Docetaxel during 6 cycles. Patients with or without complete response will continue with Perjeta+Herceptin+Endocrine therapy during 10 cycles.

A sub-set of 42 patients (35 patients from cohort A and 7 patients from cohort B) from 5 sites in Spain are participating in the LINGain sub-study "Prospective evaluation of predictive/prognostic immunogenicity biomarkers for target therapy in HER2-positive early breast cancer within the PHERGain study".

Group Type: EXPERIMENTAL

Perjeta

Intervention Type: DRUG

All patients will receive Perjeta® as an IV infusion on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent 3-week cycle. Perjeta® IV should be administered 60 minutes after the end of Herceptin® SC (subcutaneous) administration. An observation period of 30-60 minutes is recommended after each Perjeta® infusion.

Herceptin

Intervention Type: DRUG

All patients will receive a fixed dose of 600 mg, irrespective of the patient's weight, will be administered throughout the treatment phase. All doses of Herceptin® SC will be administered as an SC injection into the thigh by a trained health care professional over a period of 2-5 minutes. No loading dose is required with Herceptin® SC.

Docetaxel

Intervention Type: DRUG

Docetaxel will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC, Perjeta® IV, and carboplatin

Carboplatin

Intervention Type: DRUG

Carboplatin will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC and Perjeta® IV.

Letrozole

Intervention Type: DRUG

Postmenopausal women will receive letrozole 2.5 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Tamoxifen

Intervention Type: DRUG

Premenopausal women will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Male patients will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Cohort C

cohorts C if there is evidence of subclinic M1 assessed by 18F-FDG PET/CT at screening Interventional: Perjeta+Herceptin+Carboplatin+Docetaxel during 6 cycles. Patients will continue with Perjeta+Herceptin+Endocrine therapy (tamoxifen or letrozole) after surgery or no surgery.

Group Type: EXPERIMENTAL

Perjeta

Intervention Type: DRUG

All patients will receive Perjeta® as an IV infusion on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent 3-week cycle. Perjeta® IV should be administered 60 minutes after the end of Herceptin® SC (subcutaneous) administration. An observation period of 30-60 minutes is recommended after each Perjeta® infusion.

Herceptin

Intervention Type: DRUG

All patients will receive a fixed dose of 600 mg, irrespective of the patient's weight, will be administered throughout the treatment phase. All doses of Herceptin® SC will be administered as an SC injection into the thigh by a trained health care professional over a period of 2-5 minutes. No loading dose is required with Herceptin® SC.

Docetaxel

Intervention Type: DRUG

Docetaxel will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC, Perjeta® IV, and carboplatin

Carboplatin

Intervention Type: DRUG

Carboplatin will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC and Perjeta® IV.

Letrozole

Intervention Type: DRUG

Postmenopausal women will receive letrozole 2.5 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Tamoxifen

Intervention Type: DRUG

Premenopausal women will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Male patients will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Interventions

Perjeta

All patients will receive Perjeta® as an IV infusion on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent 3-week cycle. Perjeta® IV should be administered 60 minutes after the end of Herceptin® SC (subcutaneous) administration. An observation period of 30-60 minutes is recommended after each Perjeta® infusion.

Intervention Type: DRUG

Herceptin

All patients will receive a fixed dose of 600 mg, irrespective of the patient's weight, will be administered throughout the treatment phase. All doses of Herceptin® SC will be administered as an SC injection into the thigh by a trained health care professional over a period of 2-5 minutes. No loading dose is required with Herceptin® SC.

Intervention Type: DRUG

Docetaxel

Docetaxel will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC, Perjeta® IV, and carboplatin

Intervention Type: DRUG

Carboplatin

Carboplatin will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC and Perjeta® IV.

Intervention Type: DRUG

Letrozole

Postmenopausal women will receive letrozole 2.5 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Intervention Type: DRUG

Tamoxifen

Premenopausal women will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Male patients will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.

Intervention Type: DRUG

Other Intervention Names

Pertuzumab; Trastuzumab

Eligibility Criteria

Inclusion Criteria

1. Written informed consent prior to beginning specific protocol procedures.

2. Female or male patients ≥ 18 years of age.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

4. Histologically proven invasive breast cancer.

5. Operable breast cancer (cT1-3 and/or cN0-2 tumors) (breast cancer TNM classification)

6. Tumor size larger than or equal to 1.5 centimeter (cm) in diameter by magnetic resonance imaging (MRI) or ultrasound with a significant 18F-FDG uptake defined as maximum standarized uptake value (SUVmax: maximum standarized uptake value) ≥1.5 x SUVmean (mean standarized uptake value) liver + 2 SD (standard deviation.

Multicentric/multifocal tumors will be allowed only if:

1. Histological confirmation of at least two lesions.

2. All tumors must be HER2-positive.

3. Largest lesion must be larger than or equal to 1.5 cm in diameter by MRI or ultrasound.

7)Centrally confirmed HER2-positive disease according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria.

8)Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status locally determined prior to study entry.

Patient has adequate bone marrow, liver, and renal function:

9)Hematological: White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100.0 x109/L, and hemoglobin ≥ 10.0 g/dL (≥ 6.2 mmol/L).

10)Hepatic: total bilirubin ≤ institutional upper limit of normal (ULN) (except for Gilbert's syndrome); alkaline phosphatase (ALP) ≤ 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times ULN.

11)Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

12)Patient must be accessible for treatment and follow-up.

Exclusion Criteria

1. Previous treatment with chemotherapy, anti-HER2 therapy, radiation therapy, or endocrine therapy for invasive breast cancer.

2. cT4 and/or cN3 tumors (TNM breast cancer classification)

3. Bilateral breast cancer.

4. Evidence of metastatic disease by routine clinical assessment chest x-ray, liver ultrasound, and bone scan; or computed tomography (CT) scan of thorax and abdomen and bone scan, except patients with subclinic M1 (metastases) at baseline only according to 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) that will be allowed to be included into cohort C.

5. Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances.

6. History of other malignancy within the last five years prior to first dose of study drug administration, except for curatively treated basal and squamous cell carcinoma of the skin and/or in situ cervical carcinoma.

7. Left ventricular ejection fraction (LVEF) below 55% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO).

8. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) despite adequate antihypertensive treatment.

9. Clinically significant cardiovascular disease [stroke, unstable angina pectoris, or documented myocardial infarction within six months prior to study entry; history of documented congestive heart failure (CHF) (New York Heart Association II-III-IV); symptomatic pericarditis; documented cardiomyopathy; ventricular arrythmias with the exception of benign premature ventricular contractions; conduction abnormality requiring a pacemaker; other arrhythmias not controlled with medication].

10. Active uncontrolled infection at the time of enrollment.

11. Current known infection with HIV, hepatitis B virus, or hepatitis C virus.

12. Patients with pulmonary disease requiring continuous oxygen therapy.

13. Previous history of bleeding diathesis.

14. Patient is currently receiving anti-coagulant therapy, chronic treatment with corticosteroids, or another immunosuppressive agent (standard premedication for chemotherapy and local applications are allowed).

15. Major surgical procedure or significant traumatic injury within 14 days prior to randomization or anticipation of need for major surgery within the course of the study treatment.

16. Patient has other concurrent severe and/or uncontrolled medical conditions that would, in the investigator´s judgment, contraindicate her participation in the clinical study.

17. Concurrent participation in other clinical trial, except other translational studies.

18. History of receiving any investigational treatment within 28 days prior to randomization.

19. Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol.

LINGain sub-study: The LINGAIN project intends to include a total of 126 blood samples from PHERGain trial, as follows:

105 from patients treated with trastuzumab and pertuzumab ± endocrine therapy (according to HR status); 21 from patients treated with trastuzumab and pertuzumab + carboplatin and docetaxel.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedSIR

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Llombart, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Arnau de Vilanova

Locations

Institute Jules Bordet

Brussels, , Belgium

CLCC d'Auvergne. Centre Jean Perrin.

Clermont-Ferrand, , France

Institute de Cancerologie de Laurraine

Nancy, , France

Groupe Hospitalier Diaconesses

Paris, , France

Hopital Tenon

Paris, , France

Hospital Georges Pompidou

Paris, , France

Centre Paul Strauss

Strasbourg, , France

Institut Claudius Régaud

Toulouse, , France

Kliniken Essen Mitte

Essen, , Germany

Klinikum der Med. Fakultät Halle

Halle, , Germany

National center for tumor disease NCT

Heidelberg, , Germany

Städtisches Klinikum "St. Georg" Leipzig

Leipzig, , Germany

Clinical of Nuclear Medicine Technical University Munich

Munich, , Germany

Hämatologisch-Onkologische Schwerpunktpraxis

München, , Germany

Ospedale Maggiore Bologna

Bologna, , Italy

Ospedale Antonio Perrino

Brindisi, , Italy

Istituto Ospedalieri di Cremona

Cremona, , Italy

Ospedale Mantova

Mantova, , Italy

Istituto Europeo di Oncologia

Milan, , Italy

Ospedale San Gerardo

Monza, , Italy

Ospedale Guglielmo de Saliceto

Piacenza, , Italy

Hospital Senhora da Oliveira

Guimarães, , Portugal

Hospital Beatriz Angelo

Lisbon, , Portugal

Hospital da Luz

Lisbon, , Portugal

Hospital Fernando Fonseca

Lisbon, , Portugal

Centro Hospitalar Sao Joao

Porto, , Portugal

Hospital do Santo Antonio

Porto, , Portugal

Centro Hospitalaer de Tras-os-Montes e Alto Douro

Vila Real, , Portugal

ICO Badalona

Badalona, Barcelona, Spain

ICO l'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Provincial de Castellón

Castelló, Castelló, Spain

Hospital de Jaén

Jaén, Jaén, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Hospital San Joan de Reus

Reus, Tarragona, Spain

Hospital Universitario A Coruña

A Coruña, , Spain

Hospital Vall D'Hebrón

Barcelona, , Spain

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Hospital Universitario de Burgos

Burgos, , Spain

Hospital Reina Sofía

Córdoba, , Spain

ICO Girona

Girona, , Spain

Hospital Arnau de Vilanova

Lleida, , Spain

Hospital La Paz

Madrid, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

CHUS Santiago de Compostela

Santiago de Compostela, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital Arnau de Vilanova

Valencia, , Spain

Hospital Clínic Universitari de Valencia

Valencia, , Spain

Hospital Dr Peset

Valencia, , Spain

Hospital General Universitari de Valencia

Valencia, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Instituto Valenciano de Oncologia

Valencia, , Spain

Hospital Lozano Blesa

Zaragoza, , Spain

Hospital Universitario Miquel Servet

Zaragoza, , Spain

Barts Cancer Institute

London, , United Kingdom

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Royal Cornwall Hospital

Truro, , United Kingdom

Countries

Belgium; France; Germany; Italy; Portugal; Spain; United Kingdom

References

Llombart-Cussac A, Prat A, Perez-Garcia JM, Mateos J, Pascual T, Escriva-de-Romani S, Stradella A, Ruiz-Borrego M, de Las Heras BB, Keyaerts M, Galvan P, Braso-Maristany F, Garcia-Mosquera JJ, Guiot T, Gion M, Sampayo-Cordero M, Di Cosimo S, Perez-Escuredo J, de Frutos MA, Cortes J, Gebhart G. Clinicopathological and molecular predictors of [18F]FDG-PET disease detection in HER2-positive early breast cancer: RESPONSE, a substudy of the randomized PHERGain trial. Eur J Nucl Med Mol Imaging. 2024 Jul;51(9):2733-2743. doi: 10.1007/s00259-024-06683-0. Epub 2024 Apr 8.

Reference Type: DERIVED

PMID: 38587643 (View on PubMed)

Perez-Garcia JM, Cortes J, Ruiz-Borrego M, Colleoni M, Stradella A, Bermejo B, Dalenc F, Escriva-de-Romani S, Calvo Martinez L, Ribelles N, Marme F, Cortes A, Albacar C, Gebhart G, Prat A, Kerrou K, Schmid P, Braga S, Di Cosimo S, Gion M, Antonarelli G, Popa C, Szostak E, Alcala-Lopez D, Gener P, Rodriguez-Morato J, Mina L, Sampayo-Cordero M, Llombart-Cussac A; PHERGain Trial Investigators. 3-year invasive disease-free survival with chemotherapy de-escalation using an 18F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): a randomised, open-label, phase 2 trial. Lancet. 2024 Apr 27;403(10437):1649-1659. doi: 10.1016/S0140-6736(24)00054-0. Epub 2024 Apr 3.

Reference Type: DERIVED

PMID: 38582092 (View on PubMed)

Perez-Garcia JM, Gebhart G, Borrego MR, Schmid P, Marme F, Prat A, Dalenc F, Kerrou K, Colleoni M, Braga S, Malfettone A, Sampayo-Cordero M, Cortes J, Llombart-Cussac A. Trastuzumab and pertuzumab without chemotherapy in early-stage HER2+ breast cancer: a plain language summary of the PHERGain study. Future Oncol. 2022 Oct;18(33):3677-3688. doi: 10.2217/fon-2022-0663. Epub 2022 Oct 27.

Reference Type: DERIVED

PMID: 36300423 (View on PubMed)

Perez-Garcia JM, Gebhart G, Ruiz Borrego M, Stradella A, Bermejo B, Schmid P, Marme F, Escriva-de-Romani S, Calvo L, Ribelles N, Martinez N, Albacar C, Prat A, Dalenc F, Kerrou K, Colleoni M, Afonso N, Di Cosimo S, Sampayo-Cordero M, Malfettone A, Cortes J, Llombart-Cussac A; PHERGain steering committee and trial investigators. Chemotherapy de-escalation using an 18F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):858-871. doi: 10.1016/S1470-2045(21)00122-4. Epub 2021 May 18.

Reference Type: DERIVED

PMID: 34019819 (View on PubMed)

Other Identifiers

2016-002676-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MedOPP096

Identifier Type: -

Identifier Source: org_study_id