Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT05012644

Collaborator

(none)

197

Enrollment

Location

9.7

Actual Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to assess real-world tumor response in pre/perimenopausal HR+/HER2- metastatic breast cancer (MBC) patients initiating palbociclib + aromatase inhibitor (AI) or AI alone as first-line therapy during the period on or after 01 January 2010 to on or before 30 June 2020. Data will be obtained from structured data fields within an electronic health record (EHR) database and will be supplemented by additional unstructured data collected through a targeted chart review.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Palbociclib + aromatase inhibitor Drug: Aromatase inhibitor

Study Design

Study Type:

Observational

Actual Enrollment :

197 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

REAL-WORLD TUMOR RESPONSE OF PALBOCICLIB IN COMBINATION WITH AN AROMATASE INHIBITOR AS FIRST-LINE THERAPY IN PRE/PERIMENOPAUSAL WOMEN WITH METASTATIC BREAST CANCER

Actual Study Start Date :

Feb 17, 2021

Actual Primary Completion Date :

Dec 9, 2021

Actual Study Completion Date :

Dec 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Palbociclib + aromatase inhibitor Palbociclib + aromatase inhibitor	Drug: Palbociclib + aromatase inhibitor Palbociclib + aromatase inhibitor
Aromatase inhibitor alone Aromatase inhibitor alone	Drug: Aromatase inhibitor Aromatase inhibitor

Arm

Intervention/Treatment

Palbociclib + aromatase inhibitor

Drug: Palbociclib + aromatase inhibitor

Palbociclib + aromatase inhibitor

Aromatase inhibitor alone

Drug: Aromatase inhibitor

Aromatase inhibitor

Outcome Measures

Primary Outcome Measures

Real World Response Rate (rwRR) -Estimation in patients treated with palbociclib + AI compared to AI alone [From first dose of first line MBC treatment within the time period of Jan 2010 to June 2020 (data collected retrospectively) with a data cutoff of Dec 2020.]
rwRR defined as the proportion of patients with real-world tumor response consisting of complete response (CR) or partial response (PR) based on all recorded response assessments during first-line therapy captured with chart review.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pre or perimenopausal at MBC diagnosis
Diagnosis of MBC in patient history
Confirmed HR+/HER2- status as defined as: a. HR+: ER+ or PR+ test; b. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, fluorescence in situ hybridization [FISH] positive/amplified, positive not otherwise specified [NOS]).
Received one of the following regimens as first-line treatment for MBC during the period from 01 January 2010 through index period 30 June 2020 until the data cutoff date of 31 December 2020.
Palbociclib + AI as first-line treatment for MBC or
Monotherapy AI as first-line treatment for MBC
Received care at a US Oncology Network (USON) site(s) utilizing the full EHR capacities of iKnowMed (iKM) at the time of treatment.
EHR data available from the USON site(s) where the patient received treatment are accessible for research purposes.

Exclusion Criteria:

Evidence of prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors (palbociclib, ribociclib or abemaciclib) in the early breast cancer (BC) or MBC setting.
First structured activity (clinical visit) greater than 120 days after MBC diagnostic date with chart review to confirm no initial MBC treatment outside USON.
Receipt of treatment indicated for another primary cancer during the study observation period (after initiation of Palbociclib + AI or AI monotherapy and before 31 December