Clinical trial NCT05012644: Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: pre-menopausal
palbociclib
aromatase inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 197
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pre-menopausal metastatic breast cancer patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Real World Tumor Response (rwTR) of All Participants (Adjusted by Normalized Inverse Probability of Treatment Weighting [nIPTW])
timeFrame: 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020.
measure: Real World Tumor Response in Patients With Tumor Assessment (Adjusted by nIPTW)
timeFrame: 11 Years. From 01 January 2010 to 30 June 2020 were assessed. The study data cutoff date was on 31 December 2020.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer New York
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: