Clinical trial · Observational

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

NCT06805812CI-TRIAL-00085395PALMARES-2recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (38)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Abemaciclib	—	UNRESOLVED	—
Breast Adenocarcinoma	Breast Adenocarcinoma	ONTOLOGY_EXACT	0.98
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Breast Cancer, Metastatic	Malignant Breast Neoplasm	CURATED_BROADER	0.78
Breast Cancer Stage IV	Malignant Breast Neoplasm	CURATED_BROADER	0.78
Breast Cancer With Metastatic Bone Disease	—	UNRESOLVED	—
Breast Carcinoma	Breast Carcinoma	ONTOLOGY_EXACT	0.98
Breast Diseases	—	UNRESOLVED

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Abemaciclib	Drug	Abemaciclib	ALIAS
Palbociclib	Drug	Palbociclib	ALIAS
Ribociclib	Drug	Ribociclib	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Overall Survival (OS)
timeFrame
From the first-line treatment start to date of any-cause death or last follow up, up to 120 months

Secondary outcomes (3)

measure
Real-world Progression-Free Survival (rwPFS)
timeFrame
From the start of first-line treatment to date of disease progression documented in patient medical charts or death or last follow up, whichever occurs first, up to 120 months
measure
Time To Next Treatment or Death (TTNT-D)
timeFrame
From the start of first-line treatment to date of subsequent therapy start or death or last follow up, whichever occurs first, up to 120 months
measure
Time To Chemotherapy or Death (TTC-D)
timeFrame
From the start of first-line treatment to date of first chemotherapy for advanced disease start or death or last follow up, whichever occurs first, up to 120 months

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment