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A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer (PREcoopERA)

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Giredestrant
Triptorelin
Anastrozole
Sponsored by
ETOP IBCSG Partners Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Premenopausal women age ≥18 years, premenopausal status defined as: Estradiol (E2) in the premenopausal range (according to institution parameters) or Patient has been menstruating regularly during the 6 months prior to screening and has not used any form of hormonal contraception or any other hormonal treatments during this time. Histologically confirmed, operable invasive breast carcinoma. Eligible for upfront breast conservative surgery or upfront mastectomy: stage I, stage II or operable stage III (excludes T4) (AJCC Cancer Staging Manual 8th edition 2017).46 Tumor size must be ≥1.0 cm Multicentric and multifocal tumors and bilateral breast cancers are allowed but investigators must ensure the same tumor foci is biopsied pre-treatment and post-treatment (e.g., via clipping of the biopsied tumor foci). Documented estrogen receptor (ER)-positive tumor in accordance to ASCO/CAP guidelines (Allison et al. 2020),47 assessed locally and defined as ≥1% of tumor cells stained positive. Documented human epidermal growth factor receptor-2 (HER2)-negative tumor in accordance to 2018 ASCO/CAP guidelines (Wolff et al. 2018)48, as determined per local assessment. Ki 67 ≥10% in diagnostic biopsy as determined per local assessment. Eastern Cooperative Oncology Group Performance Status 0-1. Resting heart rate ≥40 bpm. Normal hematologic status Normal renal function Normal liver function INR <1.5× ULN and PTT <1.5x ULN Except for patients receiving anticoagulation therapy. For patients receiving warfarin, a stable INR between 2 and 3 is required. For patients receiving heparin, PTT between 1.5 and 2.5 x ULN (or value before patient started heparin treatment) is required. If anticoagulation therapy is required for a prosthetic heart valve, stable INR between 2.5 and 3.5 is permitted. Negative serum or urine beta HCG pregnancy test within 5 weeks prior to randomization. Pregnancy test will be repeated on day 1, before the first dose of WOO treatment. Women of childbearing potential must use highly effective contraceptive methods during the treatment period and for 10 days after the final dose. Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization. The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines. The patient agrees to the submission of tumor (diagnostic pre-treatment core biopsy and post-treatment re-biopsy) and blood samples for central pathology review (CPR) and for translational studies as part of this protocol. Exclusion Criteria: Stage IV (metastatic) breast cancer. Inflammatory breast cancer (cT4d). Previous systemic or local treatment for the primary breast cancer currently under investigation. Received any GnRH/LHRH analog within 12 months prior to randomization Major surgery within 4 weeks prior to randomization. Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. History of documented hemorrhagic diathesis, coagulopathy, or thromboembolism. Active cardiac disease or history of cardiac dysfunction, including any of the following: History or presence of symptomatic bradycardia or resting heart rate <50 bpm at screening. Patients on stable dose of a beta-blocker or calcium channel antagonist for pre-existing baseline conditions (e.g., hypertension) may be permitted if resting heart rate is ≥50 bpm. History of angina pectoris, symptomatic pericarditis, myocardial infarction, or any cardiac arrhythmias (e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality) within 12 months prior to study entry History of documented congestive heart failure (New York Heart Association Class II-IV) or cardiomyopathy Left ventricular ejection fraction <50% as determined by multiple-gated acquisition scan or echocardiogram QT interval corrected through use of Fridericia's formula (QTcF) >470 ms based on mean value of triplicate ECGs, history of long or short QT syndrome, Brugada syndrome or known history of corrected QT interval prolongation, or torsades de pointes History or presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, sick sinus syndrome, or evidence of prior myocardial infarction History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of long QT syndrome. Current treatment with medications that are well known to prolong the QT interval. Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment. Known issues with swallowing oral medication. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery including gastric resection. Serious infection requiring oral or IV antibiotics, or other clinically significant infection within 14 days prior to screening. Any active tumor of non-breast-cancer histology. Women who are pregnant or in the period of lactating. Any concurrent disease or 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. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. Contraindications or known hypersensitivity to the trial medication or excipients. Treatment with any investigational agents within 30 days prior to expected start of trial treatment.

Sites / Locations

  • HELIOS Klinikum Berlin Buch
  • Praxisklinik Krebsheilkunde formerly MediOnko-Institut GbR
  • KEM / Kliniken Essen Mitte
  • Klinikum der J. W. Goethe Universität
  • Universitätsklinikum Schleswig-Holstein
  • St. Elisabeth Krankenhaus
  • Universitätsklinikum Mannheim GmbH
  • Klinikum Südstadt
  • Universitätsklinikum Ulm
  • Helios Klinikum Wuppertal GmbH
  • National Institute of Oncology
  • Cork University Hospital
  • University Hospital Galway
  • University Hospital Limerick
  • Clinica Oncologica AOU Riuniti Ancona
  • Humanitas Gavazzeni
  • ASL BR Azienda Sanitaria Locale
  • IRCCS Ospedale Policlinico San Martino
  • Istituto oncologico romagnolo per lo studio dei tumori "Dino Amadori"
  • Istituto Europeo di Oncologia
  • AOU maggiore della carita
  • Istituti Clinici Scientifici Maugeri SpA-SB
  • Azienda USL Toscana Centro
  • Rimini Oncology department
  • Fondazione Policlinico Gemelli Medical Oncology Unit
  • Policlinico universitario Agostino Gemelli IRCCS Rome
  • Complejo Hospitalario Universitario Badajoz
  • Institut Catala D'oncologia ICO-Badalona
  • Institut Catala d'Oncologia - Hospitalet
  • H.U. Arnau de Vilanova de Lleida
  • CIOCC (Centro Integral Oncológico Clara Campal)
  • Fundación Jiménez Díaz
  • Hospital Universitari Son Espases
  • H. la Fé
  • Sahlgrenska Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm A: Giredestrant

Arm B: Giredestrant plus triptorelin

Arm C: Anastrozole plus triptorelin

Arm Description

Giredestrant

Giredestrant plus triptorelin

Anastrozole plus triptorelin

Outcomes

Primary Outcome Measures

Change in Ki 67
The primary endpoint is the change in Ki 67 (Ki 67-labeling index, the percentage immunostaining cells measured by IHC in central laboratory) between the pre-treatment tumor biopsy and a post-treatment tumor re-biopsy (analyzed on the natural logarithm scale).

Secondary Outcome Measures

Complete cell cycle arrest (CCCA)
Complete cell cycle arrest (CCCA), defined as Ki 67 ≤2.7% on the post -treatment tumor re-biopsy on day 29 (±3 days), by visual image analysis.
Adverse events according to CTCAE v5.0
Record all AEs (including SAEs and AESIs) and assign the appropriate grade according to the CTCAE v5.0.

Full Information

First Posted
May 31, 2023
Last Updated
October 17, 2023
Sponsor
ETOP IBCSG Partners Foundation
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05896566
Brief Title
A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
Acronym
PREcoopERA
Official Title
A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ETOP IBCSG Partners Foundation
Collaborators
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus anastrozole plus triptorelin (C).
Detailed Description
The primary objectives are: to determine if 4 weeks of giredestrant plus triptorelin provides greater anti-proliferative activity than anastrozole plus triptorelin among premenopausal patients with ER-positive/HER2-negative operable invasive breast cancer. to determine if 4 weeks of giredestrant without triptorelin provides anti-proliferative activity that is similar (non-inferior) to giredestrant plus triptorelin among premenopausal patients with ER-positive/HER2-negative operable invasive breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Window of opportunity trial with no therapeutic intent, no efficacy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Giredestrant
Arm Type
Experimental
Arm Description
Giredestrant
Arm Title
Arm B: Giredestrant plus triptorelin
Arm Type
Experimental
Arm Description
Giredestrant plus triptorelin
Arm Title
Arm C: Anastrozole plus triptorelin
Arm Type
Active Comparator
Arm Description
Anastrozole plus triptorelin
Intervention Type
Drug
Intervention Name(s)
Giredestrant
Intervention Description
Giredestrant: 30 mg daily, PO from day 1 until the day of re-biopsy/surgery.
Intervention Type
Drug
Intervention Name(s)
Triptorelin
Intervention Description
Triptorelin: 3.75 mg IM on day 1. Note: If re-biopsy/surgery cannot be done on day 29 (±3 days) from the first injection, then a second dose of triptorelin should be given on day 29 (±3 days).
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Intervention Description
Anastrozole: 1 mg daily, PO from day 1 until the day of re-biopsy/surgery.
Primary Outcome Measure Information:
Title
Change in Ki 67
Description
The primary endpoint is the change in Ki 67 (Ki 67-labeling index, the percentage immunostaining cells measured by IHC in central laboratory) between the pre-treatment tumor biopsy and a post-treatment tumor re-biopsy (analyzed on the natural logarithm scale).
Time Frame
From date of randomisation until 29 ±3 days post-randomisation
Secondary Outcome Measure Information:
Title
Complete cell cycle arrest (CCCA)
Description
Complete cell cycle arrest (CCCA), defined as Ki 67 ≤2.7% on the post -treatment tumor re-biopsy on day 29 (±3 days), by visual image analysis.
Time Frame
From date of randomisation until 29 ±3 days post-randomisation
Title
Adverse events according to CTCAE v5.0
Description
Record all AEs (including SAEs and AESIs) and assign the appropriate grade according to the CTCAE v5.0.
Time Frame
From the date of enrolment until last patient last visit (approximately 28 months after randomisation of the first patient)]

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premenopausal women age ≥18 years, premenopausal status defined as: Estradiol (E2) in the premenopausal range (according to institution parameters) or Patient has been menstruating regularly during the 6 months prior to screening and has not used any form of hormonal contraception or any other hormonal treatments during this time. Histologically confirmed, operable invasive breast carcinoma. Eligible for upfront breast conservative surgery or upfront mastectomy: stage I, stage II or operable stage III (excludes T4) (AJCC Cancer Staging Manual 8th edition 2017).46 Tumor size must be ≥1.0 cm Multicentric and multifocal tumors and bilateral breast cancers are allowed but investigators must ensure the same tumor foci is biopsied pre-treatment and post-treatment (e.g., via clipping of the biopsied tumor foci). Documented estrogen receptor (ER)-positive tumor in accordance to ASCO/CAP guidelines (Allison et al. 2020),47 assessed locally and defined as ≥1% of tumor cells stained positive. Documented human epidermal growth factor receptor-2 (HER2)-negative tumor in accordance to 2018 ASCO/CAP guidelines (Wolff et al. 2018)48, as determined per local assessment. Ki 67 ≥10% in diagnostic biopsy as determined per local assessment. Eastern Cooperative Oncology Group Performance Status 0-1. Resting heart rate ≥40 bpm. Normal hematologic status Normal renal function Normal liver function INR <1.5× ULN and PTT <1.5x ULN Except for patients receiving anticoagulation therapy. For patients receiving warfarin, a stable INR between 2 and 3 is required. For patients receiving heparin, PTT between 1.5 and 2.5 x ULN (or value before patient started heparin treatment) is required. If anticoagulation therapy is required for a prosthetic heart valve, stable INR between 2.5 and 3.5 is permitted. Negative serum or urine beta HCG pregnancy test within 5 weeks prior to randomization. Pregnancy test will be repeated on day 1, before the first dose of WOO treatment. Women of childbearing potential must use highly effective contraceptive methods during the treatment period and for 10 days after the final dose. Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization. The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines. The patient agrees to the submission of tumor (diagnostic pre-treatment core biopsy and post-treatment re-biopsy) and blood samples for central pathology review (CPR) and for translational studies as part of this protocol. Exclusion Criteria: Stage IV (metastatic) breast cancer. Inflammatory breast cancer (cT4d). Previous systemic or local treatment for the primary breast cancer currently under investigation. Received any GnRH/LHRH analog within 12 months prior to randomization Major surgery within 4 weeks prior to randomization. Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. History of documented hemorrhagic diathesis, coagulopathy, or thromboembolism. Active cardiac disease or history of cardiac dysfunction, including any of the following: History or presence of symptomatic bradycardia or resting heart rate <50 bpm at screening. Patients on stable dose of a beta-blocker or calcium channel antagonist for pre-existing baseline conditions (e.g., hypertension) may be permitted if resting heart rate is ≥50 bpm. History of angina pectoris, symptomatic pericarditis, myocardial infarction, or any cardiac arrhythmias (e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality) within 12 months prior to study entry History of documented congestive heart failure (New York Heart Association Class II-IV) or cardiomyopathy Left ventricular ejection fraction <50% as determined by multiple-gated acquisition scan or echocardiogram QT interval corrected through use of Fridericia's formula (QTcF) >470 ms based on mean value of triplicate ECGs, history of long or short QT syndrome, Brugada syndrome or known history of corrected QT interval prolongation, or torsades de pointes History or presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, sick sinus syndrome, or evidence of prior myocardial infarction History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of long QT syndrome. Current treatment with medications that are well known to prolong the QT interval. Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment. Known issues with swallowing oral medication. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery including gastric resection. Serious infection requiring oral or IV antibiotics, or other clinically significant infection within 14 days prior to screening. Any active tumor of non-breast-cancer histology. Women who are pregnant or in the period of lactating. Any concurrent disease or 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. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. Contraindications or known hypersensitivity to the trial medication or excipients. Treatment with any investigational agents within 30 days prior to expected start of trial treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Roschitzki, PhD
Phone
+41 31 511 94 00
Email
heidi.roschitzki@etop.ibcsg.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabetta Munzone, MD
Organizational Affiliation
European Institute of Oncology, Milano
Official's Role
Study Chair
Facility Information:
Facility Name
HELIOS Klinikum Berlin Buch
City
Berlin
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Untch
Email
michael.untch@helios-gesundheit.de
Facility Name
Praxisklinik Krebsheilkunde formerly MediOnko-Institut GbR
City
Berlin
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oskay Öczelik
Email
studienoskay@medionko.de
Facility Name
KEM / Kliniken Essen Mitte
City
Essen
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mattea Reinisch
Email
m.reinisch@kem-med.com
Facility Name
Klinikum der J. W. Goethe Universität
City
Frankfurt
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Solbach
Email
kfg-brustzentrum@kgu.de
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion van Mackelenbergh
Email
MarionTina.vanMackelenbergh@uksh.de
Facility Name
St. Elisabeth Krankenhaus
City
Leipzig
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dagmar Langanke
Email
dagmar.langanke@ek-leipzig.de
Facility Name
Universitätsklinikum Mannheim GmbH
City
Mannheim
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederik Marme
Email
Frederik.Marme@umm.de
Facility Name
Klinikum Südstadt
City
Rostock
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toralf Reimer
Email
toralf.reimer@kliniksued-rostock.de
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigitte Rack
Email
Rack_Studien.UFK@uniklinik-ulm.de
Facility Name
Helios Klinikum Wuppertal GmbH
City
Wuppertal
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vesna Bjelic-Radisic
Email
Vesna.Bjelic-Radisic@helios-gesundheit.de
Facility Name
National Institute of Oncology
City
Budapest
Country
Hungary
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gábor Rubovszky
Email
rubovszky.gabor@oncol.hu
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
Facility Name
University Hospital Limerick
City
Limerick
Country
Ireland
Facility Name
Clinica Oncologica AOU Riuniti Ancona
City
Ancona
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rossana Berardi
Email
Rossana.Berardi@ospedaliriuniti.marche.it
Facility Name
Humanitas Gavazzeni
City
Bergamo
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Conforti
Email
fabio.conforti@gavazzeni.it
Facility Name
ASL BR Azienda Sanitaria Locale
City
Brindisi
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saverio Cinieri
Email
saverio.cinieri@asl.brindisi.it
Facility Name
IRCCS Ospedale Policlinico San Martino
City
Genova
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Lambertini
Email
matteo.lambertini@unige.it
Facility Name
Istituto oncologico romagnolo per lo studio dei tumori "Dino Amadori"
City
Meldola
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ugo De Giorgi
Email
ugo.degiorgi@irst.emr.it
Facility Name
Istituto Europeo di Oncologia
City
Milano
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabetta Munzone
Email
elisabetta.munzone@ieo.it
Facility Name
AOU maggiore della carita
City
Novara
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Gennari
Email
alessandra.gennari@med.uniupo.it
Facility Name
Istituti Clinici Scientifici Maugeri SpA-SB
City
Pavia
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Deborah Locati
Email
lauradeborah.locati@icsmaugeri.it
Facility Name
Azienda USL Toscana Centro
City
Prato
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Biganzoli
Email
laura.biganzoli@uslcentro.toscana.it
Facility Name
Rimini Oncology department
City
Rimini
Country
Italy
Facility Name
Fondazione Policlinico Gemelli Medical Oncology Unit
City
Roma
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilio Bria
Email
emilio.bria@policlinicogemelli.it
Facility Name
Policlinico universitario Agostino Gemelli IRCCS Rome
City
Roma
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Fabi
Email
alessandra.fabi@policlinicogemelli.it
Facility Name
Complejo Hospitalario Universitario Badajoz
City
Badajoz
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Delgado
Email
ignacio.delgado@salud-juntaex.es
Facility Name
Institut Catala D'oncologia ICO-Badalona
City
Badalona
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milana Bergamino
Email
milana.bergamino@iconcologia.net
Facility Name
Institut Catala d'Oncologia - Hospitalet
City
Barcelona
Country
Spain
Facility Name
H.U. Arnau de Vilanova de Lleida
City
Lleida
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serafín Morales
Email
smorales.lleida.ics@gencat.cat
Facility Name
CIOCC (Centro Integral Oncológico Clara Campal)
City
Madrid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Rojas Garcia
Email
Beatrizrojas1981@gmail.com
Facility Name
Fundación Jiménez Díaz
City
Madrid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann Izarzugaza
Email
yizarzugaza@fjd.es
Facility Name
Hospital Universitari Son Espases
City
Palma De Mallorca
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonia Perello
Email
antonia.perellom@ssib.es
Facility Name
H. la Fé
City
Valencia
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena de la Cueva
Email
delacueva_hel@gva.es
Facility Name
Sahlgrenska Comprehensive Cancer Center
City
Gothenburg
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Karlsson
Email
per.karlsson@oncology.gu.se

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer

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