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NCT07342309 · ClinicalTrials.gov registry record
Real-World Treatment Patterns and Outcomes in HER2-Altered Metastatic Breast Cancer Patients in the United States
A clinical trial of Metastatic Breast Cancer, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- 7,933
- Enrollment target
- 1
- Study location
NCT07342309: Active study of Metastatic Breast Cancer, sponsored by Boehringer Ingelheim.
NCT07342309 is a study of Metastatic Breast Cancer that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 7,933 participants, above the 148-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (5260% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07342309, a study of Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- 7,933 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to address the following key objectives in patients with HER2-altered mBC: Primary objectives * Estimate the prevalence of human epidermal growth factor receptor 2 positive (HER2+), human epidermal growth factor receptor 2 (HER2) mutation, cooccurrence of HER2+ and HER2 mutation among adult patients with metastatic breast cancer (mBC) * Among mBC patients with HER2+ and HER2 mutation, describe the following: * Baseline demographic and clinical characteristics * Treatment patterns during follow-up including 1L through fifth-line (5L) settings * Real-world overall survival (rwOS) for 1L through 5L Secondary objectives \- Among mBC patients with HER2+ and HER2 mutation, examine the following (as permissible in the study data): * Real-world progression-free survival (rwPFS) * Real-world time to discontinuation (rwTTD) * Real-world time to next treatment (rwTTNT) * Real-world overall response rate (rwORR)
Primary Outcome
OS as an event for each patient will be defined as the date of death minus the index date + 1. For patients with no record of death, OS will be censored at the last visit date, defined as the date of the last visit of any type prior to data cutoff. Month and year of death are noted in the Flatiron Discovery Clinico-Genomic Database (CGDB); the day of death will be imputed as the midpoint (15 th) of the month of death. Endpoint will be assessed separately from the study index date (mBC diagnosi
Conditions Studied
Study Locations (1)
Connecticut
- Ridgefield - Ridgefield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,933 participants |
| Start Date | 2025-09-30 |
| Est. Completion | 2026-06-30 |
What the registry record for NCT07342309 still lists
NCT07342309 is an observational study that tracks outcomes without assigning an intervention. Its 7,933 participants enrollment target places it among the larger protocols in the corpus, above the 148-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (5260% higher).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT07342309 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT07342309 about?
NCT07342309 is a clinical study titled "Real-World Treatment Patterns and Outcomes in HER2-Altered Metastatic Breast Cancer Patients in the United States". This study aims to address the following key objectives in patients with HER2-altered mBC: Primary objectives * Estimate the prevalence of human epidermal growth factor receptor 2 positive (HER2+), human epidermal growth factor receptor 2 (HER2) mutation, cooccurrence of HER2+ and HER2 mutation am...
What is the current status of trial NCT07342309?
This trial is currently active not recruiting. The enrollment target is 7,933 participants. The study started on 2025-09-30. Estimated completion is 2026-06-30.
What conditions does trial NCT07342309 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
Who is sponsoring clinical trial NCT07342309?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07342309 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07342309's enrollment target sits among peer trials
7,933 1st of 139 higher than 139 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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