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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012644
• Other study ID #: A5481159
• Status: Completed
• Start date: February 17, 2021
• Est. completion date: December 9, 2021

Study information

• Verified date: October 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 9, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Pre or perimenopausal at MBC diagnosis

2. Diagnosis of MBC in patient history

3. 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]).

4. 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.

1. Palbociclib + AI as first-line treatment for MBC or

2. Monotherapy AI as first-line treatment for MBC

5. Received care at a US Oncology Network (USON) site(s) utilizing the full EHR capacities of iKnowMed (iKM) at the time of treatment.

6. EHR data available from the USON site(s) where the patient received treatment are accessible for research purposes.

Exclusion Criteria:

1. 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.

2. First structured activity (clinical visit) greater than 120 days after MBC diagnostic date with chart review to confirm no initial MBC treatment outside USON.

3. 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 2020) or history of another primary cancer within USON.

4. Enrolled in any interventional clinical trial after initiation of Palbociclib + AI or AI monotherapy AND before 31 December 2020.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Palbociclib + aromatase inhibitor
Palbociclib + aromatase inhibitor
• Aromatase inhibitor
Aromatase inhibitor

Locations

Country	Name	City	State
United States	Pfizer New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real World Response Rate (rwRR) -Estimation in patients treated with palbociclib + AI compared to AI alone	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.	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.

External Links

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