Advanced/Metastatic HER2-negative Breast Cancer
Conditions
Keywords
HR-positive, HER2-negative, Metastatic breast cancer
Brief summary
This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in the United States Flatiron Health Database.
Detailed description
This analysis will assess real-world outcomes in HR+/HER2- mBC patients who initiated a subsequent line of therapy (LOT) (i.e., 2L) after progressing on 1L treatment with ET+CDK4/6i. This study will also characterize the treatment patterns, clinical characteristics, and outcomes in this patient population. No study drug was administered in this non-interventional study.
Interventions
OTHERNo drug
No study drug was administered in this non-interventional study.
Sponsors
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with evidence of Stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2017 * Aged ≥18 years at mBC diagnosis date * Received 1L ET + CDK 4/6i, with no other systemic agents, in the metastatic setting * Had evidence of a rwP event during 1L ET + CDK 4/6i * Evidence of a subsequent LOT following 1L ET + CDK 4/6i (start date of subsequent LOT = index treatment date) * A record of HR+ status in the closest estrogen receptor (ER) or progesterone receptor (PR) test result occurring prior to or within 30 days after the index treatment date * A record of HER2- status in the closest HER2 test result recorded prior to or on the index treatment date * Index treatment date occurring at least 90 days prior to end of study period (30Sep2024)
Exclusion criteria
• A record of estrogen receptor 1 (ESR1), phosphatidylinositol4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), V-akt murine thymoma viral oncogene homolog (AKT1), phosphatase and tensin homolog (PTEN), or germline breast cancer gene (gBRCA) alteration/mutation prior to or within 30 days after index treatment date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world progression-free survival (rwPFS) | Baseline up to end of observation period, approximately 7 years 9 months | Real-world progression-free survival (rwPFS) will be calculated as the time from the index treatment date to the date of the first documented rwP event occurring \>14 days after the index treatment date or date of death, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-world overall survival (rwOS) | Baseline up to end of observation period, approximately 7 years 9 months | Real-world overall survival (rwOS) will be calculated as the time from the index treatment date to death. Patients who do not experience the event of interest (death) will be censored at their last confirmed activity date. |
| Real-world time to discontinuation or death (rwTTD/D) | Baseline up to end of observation period, approximately 7 years 9 months | Real-world time to treatment discontinuation or death (rwTTD/D) will be calculated for the index LOT. For the set of drugs contained in the index LOT, rwTTD/D will be calculated as the time from the first drug episode to the last drug episode or death, whichever comes first. |
| Real-world time to next treatment or death (rwTTNT/D) | Baseline up to end of observation period, approximately 7 years 9 months | Real-world time to next treatment or death (rwTTNT/D) will be calculated for the index LOT as the time from the start of the LOT to the initiation of next LOT or death, whichever comes first. |
Countries
United States
Outcome results
None listed