Clinical trial · Observational
Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy
Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy in Hormone Receptor-positive (HR+)/HER2 Receptor-negative (HER2-) Metastatic Breast Cancer (MBC): a Real World Multicentre Italian Study
NCT04524728CI-TRIAL-00046777completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary endpoint is the clinical benefit rate (CBR); secondary aims are the median PFS (mPFS), overall survival (OS) and safety.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast | — | UNRESOLVED | — |
| Female | — | UNRESOLVED | — |
| Neoplasm Malignant | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Letrozole 2.5mg | Drug | Letrozole | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- Patients that received palbociclib combined with letrozole 2.5 mg
- interventionNames
- Drug: Palbociclib
- Drug: Letrozole 2.5mg
- label
- Cohort B
- description
- Patients that received palbociclib combined with fulvestrant 500 mg
- interventionNames
- Drug: Palbociclib
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- Clinical Benefit Rate (CBR)
- timeFrame
- From the date of randomization through study completion, assessed up to 16 weeks
- description
- the percentage of patients experiencing complete response (CR), partial response (PR), or stable disease (SD) lasting 6 months or more
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pre- and postmenopausal women with a histologically proven HR+MBC, candidate to receive palbociclib plus ET as first or subsequent line of therapy according to their contingent clinical situation. * HER2- disease (IHC 0-1 or IHC 2, confirmed as FISH negative), presence of measurable or evaluable lesions and life expectancy of at least 4 months. * Adequate bone marrow, hepatic and renal function, according to clinical practice guidelines for antineoplastic drug administration Exclusion Criteria: * ER- PgR- disease * HER2+ disease (IHC 3 or IHC 2, confirmed as FISH positive) * Any cardiovascular, renal or hepatic condition that would compromise conditions in the opinion of the investigator
References
Publications (0)
Data not yet available
No reference posted for this study.