Clinical trial · Observational
Ibrance Real World Insights
TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS
NCT03159195CI-TRIAL-00091635IRIScompletedResults postedClinicalTrials.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)
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.
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 |
|---|---|---|---|
| Malignant Neoplasm of Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer Patients
- description
- HR+/HER2- advanced/metastatic breast cancer patients across multiple countries.
Primary outcomes (5)
- measure
- Percentage of Participants With Progression Free Survival (PFS) at Month 12
- timeFrame
- Day 1 of palbociclib combination treatment up to Month 12 (data recorded during 4 years of retrospective observation period)
- description
- PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) 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, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 12 months based on the Kaplan-Meier estimate were reported.
- measure
- Percentage of Participants With Progression Free Survival at Month 24
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Physician inclusion criteria * Oncologist or gynecologist * Responsible for treating a minimum of ≥2-6 (depending on country) ABC/MBC patients who meet the eligibility criteria. * Agrees to participate in the study and complete the eCRFs within the data collection period. Patient inclusion criteria * Female * ≥18 years old. * HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease. * Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s). * No prior or current enrolment in an interventional clinical trial for ABC/MBC. * Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review). * Minimum of three months of follow up data since palbociclib initiation (German interim medical record review only). * Inoperable or recurrent breast cancer (Japan only) Exclusion criteria: 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 in line with the licenced indication(s).
References
Publications (3)
- DERIVEDMycock K, Zhan L, Hart K, Taylor-Stokes G, Milligan G, Atkinson C, Mitra D. Real-world treatment patterns and clinical outcomes in patients receiving palbociclib combinations for HR+/HER2- advanced/metastatic breast cancer in Japan: Results from the IRIS study. Cancer Treat Res Commun. 2022;32:100573. doi: 10.1016/j.ctarc.2022.100573. Epub 2022 May 6. PMID 35567914
- DERIVEDMycock K, Zhan L, Taylor-Stokes G, Milligan G, Mitra D. Real-World Palbociclib Use in HR+/HER2- Advanced Breast Cancer in Canada: The IRIS Study. Curr Oncol. 2021 Jan 24;28(1):678-688. doi: 10.3390/curroncol28010066. PMID 33498797
- DERIVEDWaller J, Mitra D, Mycock K, Taylor-Stokes G, Milligan G, Zhan L, Iyer S. Real-World Treatment Patterns and Clinical Outcomes in Patients Receiving Palbociclib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer in Argentina: The IRIS Study. J Glob Oncol. 2019 May;5:JGO1800239. doi: 10.1200/JGO.18.00239. PMID 31050919