NCT06805812 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
| NCT ID | NCT06805812 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Breast Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,500 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,500 participants in total. It began in 2023-05-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Less than 3 months of follow up from the CDK4/6i start to the date of data cut-off; * Have received CDK4/6i as monotherapy; * Have received CDK4/6i as adjuvant treatment for localized disease.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06805812 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06805812 currently recruiting?
Yes, NCT06805812 is actively recruiting participants. Contact the research team at claudio.vernieri@istitutotumori.mi.it for enrollment information.
Where is the NCT06805812 trial being conducted?
This trial is being conducted at Aviano, Italy, Brescia, Italy, Catania, Italy, Como, Italy and 11 additional locations.
Who is sponsoring the NCT06805812 clinical trial?
NCT06805812 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The trial plans to enroll 3,500 participants.