Clinical trial · Observational
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HORMONE RECEPTOR POSITIVE/ HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HR+/HER2-) Advanced/Metastatic Breast Cancer In Real World Settings
- 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)
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.
Conditions
Conditions (1)
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 Cancer Metastatic | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer Patients
- description
- HR + /HER2- Advanced/Metastatic Breast Cancer patients in Latin America
Primary outcomes (24)
- measure
- Progression Free Rate at Month 6
- timeFrame
- Month 6 (from the data collected and observed retrospectively for approximately 22 months)
- description
- Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. Disease progression (PD): greater than equal to (\>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
- measure
- Progression Free Rate at Month 12
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Physician inclusion criteria: * Oncologist or gynecologist. * Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria. * Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period. Patient inclusion criteria: * HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease. * Received palbociclib as a first line therapy. * No prior or current enrolment in an interventional clinical trial for ABC/MBC. * Minimum of six months of follow up data since palbociclib initiation. Physician exclusion criteria: * Qualified less than 2 years ago or more than 35 years ago. * Participated in observational research for ABC/MBC in the last 3 months. * Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.
References
Publications (0)
Data not yet available