Clinical trial NCT03159195: Ibrance Real World Insights
Official title: TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm of Breast
Keywords: metastatic breast cancer
advanced breast cancer
HR+/ HER2-
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-05-18
Enrollment: 652
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients with HR+/HER2 advanced or metastatic breast cancer receiving palbociclib combination regimens as per the approved indication.

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
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)
measure: Percentage of Participants With Progression Free Survival at Month 24
timeFrame: Day 1 of palbociclib combination treatment up to Month 24 (data recorded during 4 years of retrospective observation period)
measure: Percentage of Participants With Objective Response Rate (ORR)
timeFrame: From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)
measure: Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation
timeFrame: 1 Year (Month 12) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)
measure: Percentage of Participants Alive After 2 Years Post Palbociclib Treatment Initiation
timeFrame: 2 years (Month 24) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With Clinical Benefit Rate (CBR)
timeFrame: From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)
measure: Percentage of Participants With Best Overall Response
timeFrame: From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)
Locations:
city: New York
country: United States
facility: Pfizer, Inc.
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Mycock 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.
citation: Mycock 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.
citation: Waller 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.