Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT04176354
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 813
Inclusion Criteria:<br><br> 1. Female sex<br><br> 2. At least 18 years old at MBC diagnosis<br><br> 3. Diagnosis of MBC at any point in patient history<br><br> 1. ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC<br><br> 2. Confirmation of metastatic disease<br><br> 3. At least 2 document clinical visits<br><br> 4. Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or<br> after 2011, as confirmed by unstructured clinical documents<br><br> 4. HR+/HER2-<br><br> 1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis<br><br> 2. HER2-: any HER2 negative test and the absence of a positive test (IHC positive<br> 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC<br> diagnosis<br><br> 5. Palbociclib + AI or letrozole as first-line therapy for MBC during the period from<br> February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to<br> allow for a possible minimum follow-up time of 90 days until the study cutoff date.<br> AI was administered within (±) 28 days of Palbociclib index date.<br><br>Exclusion Criteria:<br><br> 1. Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI<br> (Letrozole, Exemestane, and Anastrazole), Tamoxifen, Raloxifene, Toremifene, or<br> Fulvestrant for MBC<br><br> 2. First structured activity greater than 90 days after MBC diagnostic date<br><br> 3. Treatment with a CDK4/6 inhibitor as part of a clinical trial
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method
- Secondary Outcome Measures
Name Time Method Overall Survival (OS): Using Kaplan-Meier Method;Number of Participants With Real World Tumour Response (rwTR);Response Rate;Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method;Time From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method;Time to First Use of Chemotherapy: Using Kaplan-Meier Method