NCT06805812Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 3 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3500 (estimated)
- First submitted
- 7 Jan 2025
- Start date
- 1 May 2023
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06805812
What you commit to
- Study type: Observational
- Planned participants: 3500
- From 1 May 2023 to the primary completion date, 31 Dec 2030
- 24 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received CDK4/6i as monotherapy;
- Have received CDK4/6i as adjuvant treatment for localized disease.
Other
- Less than 3 months of follow up from the CDK4/6i start to the date of data cut-off;
Who the study is looking for
- Diagnosis of HR+/HER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and/or progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.
- Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+/HER2- aBC.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro di Riferimento Oncologico IRCCS Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Humanitas Istituto Clinico Catanese Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| ASST Lariana - Ospedale Sant'Anna Coordinator of this site? Confirm its status | Como | Italy | Recruiting |
| ASST Ospedale Maggiore Coordinator of this site? Confirm its status | Cremona | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale San Martino Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| Istituto Tumori della Romagna IRST IRCCS Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| Ospedale ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IEO Istituto Europeo di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ULSS 3 Veneto Coordinator of this site? Confirm its status | Mirano | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Ospedale Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
| IOV - Istituto Oncologico Veneto IRCCS Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| IRCCS - ICS Maugeri Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Policlinico Universitario Fondazione Agostino Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Clinica Ospedaliero - Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.