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NCT06805812: PALMARES-2
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
trial testing Palbociclib in Breast Adenocarcinoma in 3,500 participants. Currently enrolling.
31 December 2030
Quick facts
| Lead sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 3,500 |
| Start date | 1 May 2023 |
| Primary completion | 31 December 2030 |
| Estimated completion | 31 December 2040 |
| Sites | 24 locations across Italy |
Drugs / interventions tested
- Palbociclib (Palbociclib) — full drug profile →
- Ribociclib (ribociclib) — full drug profile →
- Abemaciclib (abemaciclib) — full drug profile →
Conditions studied
- Breast Adenocarcinoma — all drugs for Breast Adenocarcinoma →
- Breast Cancer Stage IV — all drugs for Breast Cancer Stage IV →
- Breast Cancer, Metastatic — all drugs for Breast Cancer, Metastatic →
- Breast Carcinoma — all drugs for Breast Carcinoma →
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano — full company profile →
Who can join
18 and older, any sex, with Breast Adenocarcinoma or Breast Cancer Stage IV. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06805812
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06805812 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Last refreshed: 3 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06805812.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing