Exploring outcomes in patients with HER2-positive metastatic breast cancer after treatment with Trastuzumab Deruxtecan
Real-world Outcomes of Patients With HER2-positive (HER2+) Metastatic Breast Cancer (mBC) After Treatment With Trastuzumab Deruxtecan (T-DXd) in the United States
This study looks at how well Trastuzumab Deruxtecan works for people with HER2-positive metastatic breast cancer and what happens to them after they start a new treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Daiichi Sankyo Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06833268 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze treatment patterns and clinical outcomes for patients with HER2-positive metastatic breast cancer who have been treated with Trastuzumab Deruxtecan (T-DXd). Utilizing the Flatiron Health database, the study will assess real-world progression-free survival, overall survival, and other treatment-related metrics in this patient population. The research will focus on patients who have initiated a subsequent line of therapy after their initial T-DXd treatment, providing insights into the effectiveness and sequencing of treatments in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with stage IV or recurrent HER2-positive metastatic breast cancer who have received at least one line of therapy containing T-DXd.
Not a fit: Patients who have not received T-DXd or do not have HER2-positive breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of treatment strategies for HER2-positive metastatic breast cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown success in analyzing real-world outcomes in cancer treatment, suggesting that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Patients must meet all the inclusion criteria below to be included in the study population: 1. Patients with evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011. 2. Patients aged ≥18 years old at mBC diagnosis date. 3. Patients with ≥1 T-DXd-containing LOT in the metastatic setting. 4. Patients with evidence of a subsequent LOT following the first T-DXd-containing LOT in the metastatic setting. The LOT subsequent to the first T-DXd-containing LOT in the metastatic setting will be the index LOT. Index date will be the index LOT start date. 5. Patients whose closest HER2 test result (defined as immunohistochemistry \[IHC\] 3+ or in situ hybridization \[ISH\]+) recorded prior to or on the index date was a HER2+ test result. 6. Patients with index date occurring at least 90 days prior to end of study period (March 31st, 2024). Exclusion Criteria No exclusion criteria will be imposed.
Where this trial is running
New York, New York
- Flatiron Health, Inc — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Contact for Clinical Trial Information
- Email: CTRinfo_us@daiichisankyo.com
- Phone: 9089926400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.