Evaluating T-DXd for HER2-positive breast cancer with brain metastases after pyrotinib treatment
Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment
This study is testing if a new treatment called T-DXd can help women with HER2-positive breast cancer and brain metastases who have not improved after taking pyrotinib.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Beijing 302 Hospital Academic / other |
| Drugs / interventions | pyrotinib |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT06135194 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of T-DXd in women diagnosed with HER2-positive breast cancer who have developed brain metastases following treatment with pyrotinib. Participants will be evaluated for their response to T-DXd after experiencing progression of their brain metastases. The study will include women aged 18 and older with confirmed HER2-positive status and imaging evidence of brain metastases. The research will focus on monitoring treatment outcomes and safety profiles in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with HER2-positive breast cancer and brain metastases who have shown progression after prior treatment with pyrotinib.
Not a fit: Patients with uncontrolled cardiovascular disease or significant lung conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HER2-positive breast cancer that has spread to the brain.
How similar studies have performed: While there is ongoing research in this area, the specific combination of T-DXd after pyrotinib in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (1) Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records Exclusion Criteria: * Has uncontrolled or significant cardiovascular disease * Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening * Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
Where this trial is running
Beijing, Beijing and 1 other locations
- The Fifth Medical Center of PLA General Hospital — Beijing, Beijing, China (Recruiting)
- The Fifth Medical Center of PLA General Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: jinmei zhou
- Email: jinzhu2714@sina.com
- Phone: 010-66947250
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.