A PHASE 2 STUDY TO RESEARCH THE SAFETY AND EFFICACY OF TRASTUZUMAB DERUXTECAN VERSUS CDK4/6I PLUS ENDOCRINE THERAPY IN ADVANCED BREAST CANCER PATIENTS (PONTIAC).

Start 30 Jun 2025 · Status Authorised, recruiting · 9 EU/EEA countries · 84 sites · Protocol MEDOPP556

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Authorised, recruiting

Participants planned 200

Countries 9

Sites 84

Unresectable locally recurrent or metastatic hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-low/ultralow breast cancer classified as non-luminal by gene expression profiling.

Key facts

Sponsor: Medica Scientia Innovation Research S.L.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 30 Jun 2025 → ongoing
Decision date (initial): 2025-06-11
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: Daiichi Sankyo

External identifiers

EU CT number: 2024-512360-55-00
ClinicalTrials.gov: NCT06486883

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To demonstrate that first-line T-DXd compared with CDK4/6i plus ET is superior in prolonging the progression free survival (PFS) based on investigator assessment in patients with HR-positive, HER2-low (1+ by IHC or 2+ and negative by an ISH test) advanced breast cancer classified as non-luminal by central PAM50 analysis (HER2-low population).

To demonstrate that first-line T-DXd compared with CDK4/6i plus ET is superior in prolonging the PFS based on investigator assessment in patients with HR-positive and HER2-low/ultralow advanced breast cancer classified as non-luminal by central PAM50 analysis (all patients).

Secondary objectives 12

To evaluate the efficacy of T-DXd compared with CDK4/6i plus ET in terms of OS in all patients and HER2-low population.
To determine the efficacy in terms of ORR of first-line T-DXd compared with CDK4/6i plus ET in all patients and HER2-low population.
To assess the efficacy of first-line T-DXd compared with CDK4/6i plus ET defined as CBR in all patients and HER2-low population.
To assess the efficacy defined as DoR of first-line T-DXd compared with CDK4/6i plus ET in all patients and HER2-low population.
To assess the efficacy in terms of TTR of first-line T-DXd compared with CDK4/6i plus ET in all patients and HER2-low population.
To determine the efficacy of treatment with first-line T-DXd compared with CDK4/6i plus ET defined as time to treatment failure in all patients and HER2-low population.
To determine the efficacy of treatment with first-line T-DXd compared with CDK4/6i plus ET defined as time to first subsequent chemotherapy in all patients and HER2- low population
To determine the efficacy of treatment with first-line T-DXd compared with CDK4/6i plus ET defined as best percentage of change in tumor in all patients in all patients and HER2-low population
To assess the second progression- free survival (PFS2) in all patients and HER2- low population
To assess the time to start of first subsequent therapy or death (TFST) in all patients and HER2-low population
To evaluate changes during treatment with first-line T-DXd compared with CDK4/6i plus ET in terms of PRO assessments of health-related QoL and treatment-related symptoms in all patients and HER2-low population
To evaluate the safety and toxicity profile of treatment with T-DXd compared with CDK4/6i plus ET in all patients and HER2- low population. Safety data will be presented using descriptive statistics according to the treatment received unless otherwise specified

Conditions and MedDRA coding

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 16

Patients must be capable to understand the purpose of the Study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.
Female or male patients ≥ 18 years of age at the time of signing ICF.
ECOG performance status of 0-1.
Minimum life expectancy of ≥ 12 weeks at screening.
Evidence of HER2-low expression (1+ by immunohistochemistry or 2+ and negative by an in situ hybridization [ISH] test) or HER2-ultralow (IHC 0 with faint membrane staining and in ≤ 10% of tumor cells) breast cancer according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines determined by a MEDSIR’s designated central laboratory, using Ventana 4B5 antibody. This assessment has to be done on the most recently available (archived or newly collected) formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion, excluding bone metastases.
Non-luminal breast cancer subtype as per central PAM50 analysis determined in the most recently available (archived or newly collected) FFPE tumor tissue blocks (obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion with the exception of bone metastases.
Patients must have HR-positive (estrogen receptor [ER] and/or progesterone receptor [PgR]-positive defined as ≥ 1% positive stained cells) status according to the most recent ASCO/CAP guidelines locally determined prior to Study entry.
Unresectable locally recurrent or metastatic breast cancer documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
Evaluable disease according to RECIST v.1.1. Patients with bone-only disease are not allowed. Patients with bone metastases with soft tissue masses measuring > 10 mm are eligible.
Patients must have endocrine resistance criteria: disease progression during adjuvant ET or within the first year of completing adjuvant ET; or endocrine sensitivity criteria: de novo metastatic disease or disease progression ≥ 12 months after completing adjuvant ET with at least one of the following requirements: 1. Estrogen receptor ≤ 50% positive stained cells; 2. and/or high histological grade or Ki67 > 50% on primary tumor; 3. and/or liver metastases; 4. and/or known non-luminal subtype as per local PAM50 analysis.
No prior treatment with any systemic therapy for advanced disease. Patients treated with a CDK4/6i in the adjuvant setting with a TFI ≥ 12 months following CDK4/6i treatment completion are eligible.
Patients have adequate bone marrow, liver, and renal function: • Hematological (without platelet, red blood cell transfusion, and/or granulocyte colony-stimulating factor support within 14 days before first Study treatment dose): White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100.0 x 109/L, and hemoglobin ≥ 9.0 g/dL (≥ 5.6mmol/L). • Hepatic: Serum albumin ≥ 2.5 g/dL; total bilirubin ≤ 1.5 times upper limit of normal (x ULN) (≤ 3 x ULN in patients with liver metastases or know history of Gilbert’s disease); alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver/or bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN (≤ 5 x ULN in patients with liver metastases). • Renal: Creatinine clearance ≥ 30 mL/min as determined by Cockcroft Gault (using actual body weight). • Coagulation: International normalized ratio or prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN.
Resolution of all acute toxic effects of prior anti-cancer therapy to Grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0) (except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before Study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until 7 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician’s choice of CDK4/6i plus ET. Female patients must refrain from egg cell donation and breastfeeding during this same period.
Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 4 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician’s choice of CDK4/6i plus ET. Male participants must not donate or bank sperm during this same period.
Patients must be accessible for treatment and follow-up.

Exclusion criteria 24

Current participation in another therapeutic clinical trial, except other translational studies.
Treatment with approved or investigational cancer therapy within 3 weeks prior to initiation of Study drug.
Treatment with chloroquine/hydroxychloroquine within 14 days prior to initiation of Study drug.
Have previously been treated with T-DXd and/or fulvestrant. Note I: patients who experienced relapse after more than 1 year from completion of fulvestrant are eligible. Note II: previous treatment with anti-HER2 therapies in (neo-) adjuvant setting will be allowed for participants who showed conversion from HER2-positive expression in primary breast tumor sample to HER2-low or HER2-ultralow expression (HER2 loss) in relapsed tumor sample.
Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, and/or peritoneal] and pulmonary lymphangitis).
Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of CDK4/6i, such as history of GI surgery which may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease, or diarrhea of CTCAE Grade > 1.
Known central nervous system (CNS) involvement (brain metastases and/or leptomeningeal carcinomatosis). Subjects with clinically inactive brain metastases may be included in the Study. Subjects with treated brain metastases that are no longer symptomatic and who do not require treatment with corticosteroids or anticonvulsants may be included in the Study if they have recovered from the acute toxic effect of radiotherapy.
Have a concurrent malignancy or malignancy within 5 years of Study enrollment with the exception of carcinoma in situ of the cervix and basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor’s Medical Monitor is required.
Known allergy or hypersensitivity reaction to any of the investigational medicinal products (IMPs) or their inactive ingredients.
Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks prior to start of Study treatment.
Major surgical procedure or significant traumatic injury within 4 weeks before the first dose of Study treatment or anticipation of need for major surgery within the course of the Study treatment.
Has an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following: • Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic CHF (NYHA Class II to IV), unstable angina pectoris, or a recent (< 6 months) cardiovascular event including stroke. Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation to rule out myocardial infarction. • Left ventricular ejection fraction (LVEF) < 55% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO). • History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia), which is symptomatic or requires treatment (NCI-CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers will be permitted to enroll. • QT interval corrected by Fridericia’s formula (QTcF) prolongation to > 470 ms (females) or > 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG). • History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes. • Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the Study enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, post COVID-19 pulmonary fibrosis, etc.), and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy (complete).
Has a history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.
Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test), and > 6 months off anti-viral treatment are eligible. Those participants should be closely monitored for HBV reactivation and have access to a local hepatitis B expert during and after the Study. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Patients with HCV co-infection or history of HCV co-infection are excluded.
Patients with cirrhosis or fibrosis on prior imaging or biopsy.
Has an active primary immunodeficiency or known human immunodeficiency virus (HIV) infection.
Other active uncontrolled infection at the time of enrollment.
Receipt of live or attenuated vaccine within 30 days prior to the first dose of Study treatment.
A history of uncontrolled seizures, CNS disorders, or serious and/or unstable pre-existing psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to Study drugs or interfering with subject safety.
Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Medications Section).
Known substance abuse or any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, contraindicate patient participation.
Inability or unwillingness to comply with the requirements of the protocol in the opinion of the investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

PFS, defined as the period from randomization date to the first occurrence of documented radiographic disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1. in HER2-low patients.
PFS, defined as the period from randomization date to the first occurrence of documented radiographic disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1 in all patients.

Secondary endpoints 16

OS, defined as the period from randomization date to death from any cause, as determined locally by the investigator (in all patients and HER2-low population).
ORR, defined as the rate of patients with complete response (CR) or partial response (PR), as determined locally by the investigator using RECIST v.1.1 (in all patients and HER2-low population).
CBR, defined as the rate of patients with objective response (CR or PR), or stable disease for at least 24 weeks, as determined locally by the investigator using RECIST v.1.1 (in all patients and HER2-low population).
DoR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1 (in all patients and HER2-low population).
TTR, defined as the period from randomization date to the first objective tumor response (tumor shrinkage of ≥ 30%) observed for patients who achieved a CR or PR, as determined locally by the investigator using RECIST v.1.1 (in all patients and HER2-low population).
TTF, defined as the time from randomization date to discontinuation of treatment for any reason, including progressive disease, treatment toxicity, patient choice, and death.
TFSC: time to first subsequent chemotherapy, defined as the time from randomization date to the beginning of the first subsequent chemotherapy after discontinuation of the trial regimen
Best percentage of change from baseline in the size of target tumor lesions, defined as the biggest decrease, or smallest increase if no decrease will be observed, as determined locally by the investigator using RECIST v.1.1.
PFS2 is defined as the time from randomization date to the earliest progression event after that used for the primary variable PFS, or date of death as determined locally by the investigator using RECIST v.1.1.
TFST, defined as the time from randomization to the earliest date of anti-cancer therapy start date following Study treatment discontinuation, or death.
Changes from baseline in the EORTC QLQ-C30, EORTC QLQ-BR42 scales and the EQ-5D-5L index.
Time to deteriorate in the EORTC QLQ-C30 and QLQ-BR42 subscales.
Safety endpoints: Safety and tolerability as per NCI-CTCAE v.5.0.
Exploratory endpoints can include (but are not limited to): Association of clinical outcomes, safety and/or tolerability profile with mutation profiling, copy number variability, gene expression, multiplex assays, proteomic analyses, digital pathology, immunohistochemistry, taxonomic or functional analyses performed on tissue and/or liquid biopsy samples.
Exploratory endpoints can include (but are not limited to): Efficacy endpoints for all patients according to different clinicopathological characteristics and prior treatment for early breast cancer.
Exploratory endpoints can include (but are not limited to): Association of treatment efficacy and/or safety outcomes in all patients with radiological imaging biomarkers.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

DS-8201a

PRD5308994 · Product

Active substance: Trastuzumab Deruxtecan
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 0.26 mg/Kg milligram(s)/kilogram
Max total dose: 59.4 mg/Kg milligram(s)/kilogram
Max treatment duration: 72 Week(s)
Authorisation status: Not Authorised
MA holder: DAIICHI SANKYO, INC.
Paediatric formulation: No
Orphan designation: No

Comparator 11

IBRANCE 100 mg film-coated tablets

PRD7907867 · Product

Active substance: Palbociclib
Substance synonyms: PD-332,991, PD-0332991
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/012
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

IBRANCE 75 mg film-coated tablets

PRD7907995 · Product

Active substance: Palbociclib
Substance synonyms: PD-332,991, PD-0332991
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 75 mg milligram(s)
Max total dose: 75 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/010
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

IBRANCE 125 mg film-coated tablets

PRD7907865 · Product

Active substance: Palbociclib
Substance synonyms: PD-332,991, PD-0332991
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 125 mg milligram(s)
Max total dose: 125 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/014
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Verzenios 100 mg film-coated tablets

PRD6701103 · Product

Active substance: Abemaciclib
Substance synonyms: LY2835219
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L01XE50 — -
Marketing authorisation: EU/1/18/1307/004
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Verzenios 150 mg film-coated tablets

PRD6701108 · Product

Active substance: Abemaciclib
Substance synonyms: LY2835219
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 150 mg milligram(s)
Max total dose: 150 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L01EF03 — -
Marketing authorisation: EU/1/18/1307/007
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Verzenios 50 mg film-coated tablets

PRD6701098 · Product

Active substance: Abemaciclib
Substance synonyms: LY2835219
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L01EF03 — -
Marketing authorisation: EU/1/18/1307/001
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Letrozol Tevagen 2,5 mg comprimidos recubiertos con película EFG

PRD698676 · Product

Active substance: Letrozole
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 2.5 mg milligram(s)
Max total dose: 2.5 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L02BG04 — LETROZOLE
Marketing authorisation: 72500
MA holder: TEVA PHARMA S.L.U.,
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Exemestano Teva 25 mg comprimidos recubiertos con película EFG

PRD665020 · Product

Active substance: Exemestane
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L02BG06 — EXEMESTANE
Marketing authorisation: 73282
MA holder: TEVA PHARMA S.L.U.,
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Anastrozol Teva 1 mg comprimidos recubiertos con película EFG

PRD641682 · Product

Active substance: Anastrozole
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 1 mg milligram(s)
Max total dose: 1 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L02BG03 — ANASTROZOLE
Marketing authorisation: 69430
MA holder: TEVA PHARMA S.L.U.,
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Fulvestrant Teva 250 mg solución inyectable en jeringa precargada EFG

PRD4527836 · Product

Active substance: Fulvestrant
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 250 mg milligram(s)
Max total dose: 250 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L02BA03 — FULVESTRANT
Marketing authorisation: 80910
MA holder: TEVA PHARMA S.L.U.,
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Kisqali 200 mg film-coated tablets

PRD5341538 · Product

Active substance: Ribociclib
Substance synonyms: LEE011
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L01EF02 — -
Marketing authorisation: EU/1/17/1221/001
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 2

Leuprorelin Acetate

SCP151923 · ATC

Active substance: Leuprorelin Acetate
Substance synonyms: LEUPROLIDE ACETATE
Route of administration: INFUSION
Max daily dose: 22.5 mg milligram(s)
Max total dose: 22.5 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L02AE02 — LEUPRORELIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP111850463 · ATC

Route of administration: INJECTION
Max daily dose: 3.6 mg milligram(s)
Max total dose: 3.6 mg milligram(s)
Max treatment duration: 36 Month(s)
Authorisation status: Authorised
ATC code: L02AE03 — GOSERELIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medica Scientia Innovation Research S.L.

Sponsor organisation: Medica Scientia Innovation Research S.L.
Address: Torre Glories 27th Floor, Avinguda Diagonal 211 Avinguda Diagonal 211
City: Barcelona
Postcode: 08018
Country: Spain

Scientific contact point

Organisation: Medica Scientia Innovation Research S.L.
Contact name: Alicia García

Public contact point

Organisation: Medica Scientia Innovation Research S.L.
Contact name: Marta Campolier

Locations

9 EU/EEA countries · 84 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Authorised, recruiting	10	3
Belgium	Authorised, recruiting	4	4
France	Authorised, recruiting	28	8
Germany	Authorised, recruiting	12	6
Italy	Ongoing, recruiting	46	15
Netherlands	Authorised, recruitment pending	4	1
Poland	Authorised, recruiting	8	4
Portugal	Authorised, recruiting	16	11
Spain	Ongoing, recruiting	66	32
Rest of world United Kingdom	—	6	—

Investigational sites

Austria

3 sites · Authorised, recruiting

Johannes Kepler University Linz

Hematology and Oncology, Med Campus III, Krankenhausstrasse 9, Linz

Medical University Of Graz

Internal Medicine, Neue Stiftingtalstrasse 6, 8010, Graz

Medical University Of Vienna

Department of Medicine I, Division of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna

Belgium

4 sites · Authorised, recruiting

Cliniques Universitaires Saint-Luc

Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe

Algemeen Ziekenhuis Klina

Oncology, Augustijnslei 100, 2930, Brasschaat

CHU Helora

Oncology, Boulevard President Kennedy 2, 7000, Mons

Universitair Ziekenhuis Gent

Oncology, Corneel Heymanslaan 10, 9000, Gent

France

8 sites · Authorised, recruiting

Institut Paoli Calmettes

Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille

Centre Hospitalier Universitaire De Saint Etienne

Oncology, Avenue Albert Raimond, 42270, Saint Priest En Jarez

CHU Besancon

Oncology, 3 Boulevard Alexandre Fleming, 25000, Besancon

Hospices Civils De Lyon

Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite

Centre Francois Baclesse

Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5

Centr Georges Francois Leclerc

Oncology, 1 Rue Professeur Marion, 21000, Dijon

Institut Curie

Oncology, 26 Rue D Ulm, 75005, Paris

Institut De Cancerologie De L Ouest

Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex

Germany

6 sites · Authorised, recruiting

Technische Universitaet Dresden

Gynecology, Fetscherstrasse 74, Johannstadt-Nord, Dresden

Klinikum Ernst von Bergmann gGmbH

Klinik für Gynekologie und Geburtshilfe, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam

Klinikum Aschaffenburg-Alzenau gGmbH

Oncology, Am Hasenkopf 1, Innenstadt, Aschaffenburg

KEM I Evang. Kliniken Essen-Mitte gGmbH

Gynecology, Henricistrasse 92, Huttrop, Essen

Haematologie-Onkologie im Zentrum MVZ GmbH

Oncology, Halderstrasse 29, Innenstadt, Augsburg

Klinikum Worms gGmbH

Oncology, Gabriel-Von-Seidl-Strasse 81, Herrnsheim, Worms

Italy

15 sites · Ongoing, recruiting

Ospedale Generale Provinciale Di Macerata

Oncology, Via Santa Lucia 2, 62100, Macerata

Azienda Ospedaliera Universitaria Federico II Di Napoli

Oncology, Via Sergio Pansini 5, 80131, Naples

Istituto Oncologico Veneto

Oncology, Via Gattamelata 64, 35128, Padova

Centro Di Riferimento Oncologico Di Aviano

Oncology, Via Franco Gallini 2, 33081, Aviano

Istituto Europeo Di Oncologia S.r.l.

Oncology, Via Giuseppe Ripamonti 435, 20141, Milan

IRCCS Ospedale Sacro Cuore Don Calabria

Oncology, Via Don Angelo Sempreboni 5, 37024, Negrar

Fondazione IRCCS San Gerardo Dei Tintori

Oncology, Via Giovanni Battista Pergolesi 33, 20900, Monza

IRCCS Ospedale Policlinico San Martino

Oncology, Largo Rosanna Benzi 10, 16132, Genoa

Azienda Ospedaliero Universitaria Careggi

Oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oncology, Largo Francesco Vito 1, 00168, Rome

Azienda Unita Sanitaria Locale Di Piacenza

Oncology, Via Giuseppe Taverna 49, 29121, Piacenza

Azienda Ospedaliero Universitaria Di Modena

Oncology, Largo Del Pozzo 71, 41124, Modena

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Oncology, Via Mariano Semmola 52, 80131, Naples

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Oncology, Corso Giuseppe Mazzini 18, 28100, Novara

Azienda Ospedaliero Universitaria Delle Marche

Oncology, Via Conca 71, 60126, Ancona

Netherlands

1 site · Authorised, recruitment pending

Netherlands Cancer Institute

Oncology, Plesmanlaan 121, 1066 CX, Amsterdam

Poland

4 sites · Authorised, recruiting

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Klinika Onkologii, Ul. Szaserow 128, 04-141, Warsaw

Instytut Centrum Zdrowia Matki Polki

Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz

Kliniki Neuroradiochirurgii Sp. z o.o.

Kliniczny Oddział Chemioterapii, Ul. Uniwersytecka 6a, 26-601, Radom

Medtrials Sp. z o.o.

Centrum Badań Klinicznych, Plac Lasoty 4, 30-539, Cracow

Portugal

11 sites · Authorised, recruiting

Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.

Oncology, Ulstmad, Avenida Da Noruega, Vila Real

Hospital de Cascais

Oncology, Av. Brigadeiro Victor Novais Goncalves, 2755-009, Alcabideche

Unidade Local De Saude Da Regiao De Aveiro E.P.E.

Oncology, Avenida De Artur Ravara, 3814-501, Aveiro

Unidade Local De Saude De Amadora Sintra E.P.E.

Oncology, Itinerario Complementar 19, 2720-276, Amadora

Hospital Cuf Descobertas S.A.

Oncology, Rua Mario Botas 1, 1998-018, Lisbon

Unidade Local De Saude De Santo Antonio E.P.E.

Oncology, Largo Professor Abel Salazar, 4050-011, Porto

Unidade Local De Saude De Santa Maria E.P.E.

Oncology, Avenida Professor Egas Moniz, 1649-035, Lisbon

Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.

Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto

Hospital Da Luz S.A.

Oncology, Avenida Lusiada 100, 1500-650, Lisbon

Unidade Local De Saude Do Alto Ave E.P.E.

Oncology, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes

Unidade Local De Saude De Loures-Odivelas EPE

Oncology, Avenida Carlos Teixeira 3, 2674-514, Loures

Spain

32 sites · Ongoing, recruiting

Micancer Center S.L.P.

Oncology, Calle Del Doctor Roux 76 Planta 5, 08017, Barcelona

Hospital Universitario Basurto

Oncology, Montevideo Etorbidea 16-18, 48013, Bilbao

Complexo Hospitalario Universitario De Santiago

Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela

Hospital Quironsalud Zaragoza

Oncology, Paseo Renovales S/n, 50006, Zaragoza

Salut Sant Joan De Reus

Oncology, Avinguda Del Doctor Josep Laporte 2, 43204, Reus

Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida

Oncology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida

Hospital Universitario Virgen De La Macarena

Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla

Hospital General Universitario Gregorio Maranon

Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid

University Clinical Hospital Virgen De La Arrixaca

Oncology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia

Hospital Universitario Virgen De La Victoria

Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga

Hospital Beata Maria Ana

Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid

Hospital Clinico Universitario De Valencia

Oncology, Avenida Blasco Ibanez 17, 46010, Valencia

Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro

Oncology, Rua Doctor Camilo Veiras 1, 15009, A Coruna

Hospital Quironsalud Sagrado Corazon

Oncology, Calle De Rafael Salgado 3, 41013, Sevilla

Hospital Universitario Puerta De Hierro De Majadahonda

Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda

Hospital Universitario Y Politecnico La Fe

Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia

Hospital Universitario De Jaen

Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen

Hospital Universitario Ramon Y Cajal

Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid

Hospital Universitario Clinico San Cecilio

Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada

Hospital Arnau De Vilanova De Valencia

Oncology, Calle De San Clemente 12, 46015, Valencia

Hospital Clinic De Barcelona

Oncology, Calle Villarroel 170, 08036, Barcelona

Hospital Universitario 12 De Octubre

Oncology, Avenida De Cordoba Sn, 28041, Madrid

Hospital Universitario San Juan De Alicante

Oncology, Carretera N-332 Alicante-Valencia S/n, 03550, Sant Joan D'alacant

Hospital Clinico San Carlos

Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid

Hospital Universitari Dexeus Grupo Quironsalud

Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona

Hospital San Pedro De Alcantara

Oncology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres

University Hospital Virgen Del Rocio S.L.

Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla

Hospital Clinico Universitario Lozano Blesa

Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza

Fundacion Instituto Valenciano De Oncologia

Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia

Complexo Hospitalario Universitario A Coruna

Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna

Institut Catala D'oncologia

Oncology, Avinguda De Franca S/n, 17007, Girona