Actively Recruiting
Predictive Impact of Peripheral Blood Lymphocytes on 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
521 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
Researchers are investigating advanced breast cancer that is hormone receptor-positive and HER2-negative, focusing on patients receiving first-line treatment with CDK4/6 inhibitors combined with endocrine therapy. The study is observational and multicenter, aiming to gather real-world evidence from clinical data, medical imaging, and biological samples. The study includes various sub-studies that address different aspects of treatment outcomes and patient responses. The study involves collecting data from five sub-studies: real-world clinical data comparing survival outcomes among patients treated with three CDK4/6 inhibitors; safety data on comorbidities, medications, and toxicities; medical imaging analyses using CT and PET scans; genomic and transcriptomic analyses from tumor samples; and evaluation of treatment patterns after progression on first-line therapy. These sub-studies use different methods for data collection, extraction, and analysis to build predictive models to assist treatment decisions. Participants will have their medical records reviewed for clinical outcomes, imaging studies collected and analyzed, and biological samples obtained for molecular testing. Researchers will assess overall survival up to 120 months from treatment start, along with progression-free survival and time to subsequent treatments. The study tracks severe toxicities and gathers detailed comorbidity information to understand treatment safety. Participant involvement is based on data collection rather than active treatment assignment, with the study continuing through various follow-up periods to monitor long-term outcomes.
CONDITIONS
Brief 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
- HER2 negativity confirmed by immunohistochemistry score 0, 1+, or 2+ with no gene amplification
- Received or planned to receive palbociclib, ribociclib, or abemaciclib combined with endocrine therapy as first-line treatment for advanced breast cancer
- Age 18 years or older
You will not qualify if you...
- Less than 3 months of follow-up data since starting CDK4/6 inhibitor treatment
- Received CDK4/6 inhibitor as monotherapy
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 120 months
Participants who undergo routine care with CDK4/6 inhibitors plus endocrine therapy are observed. Data including clinical information, medical images, and biological samples are collected to evaluate treatment outcomes and safety.
Visits as per routine clinical care and treatment schedules
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.
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
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