Actively Recruiting
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-02-03
3500
Participants Needed
24
Research Sites
922 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead Sponsor
E
European Institute of Oncology, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4/6i as first-line of therapy for HR+/HER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.
CONDITIONS
Official Title
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of HR+/HER2- advanced breast cancer with at least 1% estrogen or progesterone receptor positivity confirmed by immunohistochemistry
- HER2 negativity confirmed by immunohistochemistry score of 0, 1+, or 2+ without gene amplification
- Have received or are candidates to receive palbociclib, ribociclib, or abemaciclib combined with endocrine therapy as first-line treatment for HR+/HER2- advanced breast cancer
You will not qualify if you...
- Less than 3 months of follow-up from the start of CDK4/6 inhibitor treatment to data cut-off date
- Have received CDK4/6 inhibitor treatment as monotherapy
- Have received CDK4/6 inhibitor as adjuvant treatment for localized breast cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Centro di Riferimento Oncologico IRCCS
Aviano, Italy
Actively Recruiting
2
Azienda Socio Sanitaria Territoriale degli Spedali Civili
Brescia, Italy
Actively Recruiting
3
Humanitas Istituto Clinico Catanese
Catania, Italy
Actively Recruiting
4
ASST Lariana - Ospedale Sant'Anna
Como, Italy
Actively Recruiting
5
ASST Ospedale Maggiore
Cremona, Italy
Actively Recruiting
6
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Actively Recruiting
7
Ospedale San Martino
Genova, Italy
Actively Recruiting
8
Istituto Tumori della Romagna IRST IRCCS
Meldola, Italy
Actively Recruiting
9
Fondazione IRCCS Ca' Granda Ospedale Maggiore
Milan, Italy
Actively Recruiting
10
IEO Istituto Europeo di Oncologia
Milan, Italy
Actively Recruiting
11
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
12
Ospedale ASST Fatebenefratelli Sacco
Milan, Italy
Actively Recruiting
13
ULSS 3 Veneto
Mirano, Italy
Actively Recruiting
14
Azienda Ospedaliero-Universitaria
Modena, Italy
Actively Recruiting
15
Azienda Ospedaliero-Universitaria Federico II
Naples, Italy
Actively Recruiting
16
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy
Actively Recruiting
17
Ospedale Maggiore della Carità
Novara, Italy
Actively Recruiting
18
IOV Istituto Oncologico Veneto IRCCS
Padova, Italy
Actively Recruiting
19
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Actively Recruiting
20
IRCCS - ICS Maugeri
Pavia, Italy
Actively Recruiting
21
Clinica Ospedaliero - Universitaria Policlinico Umberto I
Roma, Italy
Actively Recruiting
22
Policlinico Universitario Campus Bio-Medico
Roma, Italy
Actively Recruiting
23
Policlinico Universitario Fondazione Agostino Gemelli
Roma, Italy
Actively Recruiting
24
Istituto Clinico Humanitas
Rozzano, Italy
Actively Recruiting
Research Team
C
Claudio Vernieri, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here