Clinical trial · Observational
Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
Real-World Outcomes of Patients With HR-Positive HER2-Negative Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i in the United States
NCT06975371CI-TRIAL-00096371completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced/Metastatic HER2-negative Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No drug | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HR+/HER2- metastatic breast cancer
- description
- Adults in the Flatiron database who are diagnosed with HR+/HER2- metastatic breast cancer and initiated a subsequent line of therapy (i.e., 2L) after progressing on 1L treatment with ET+CDK4/6i.
- interventionNames
- Other: No drug
Primary outcomes (1)
- measure
- Real-world progression-free survival (rwPFS)
- timeFrame
- Baseline up to end of observation period, approximately 7 years 9 months
- description
- 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 outcomes (3)
- measure
- Real-world overall survival (rwOS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.