Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06135194
• Lead Sponsor: Beijing 302 Hospital

Brief Summary

To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Status Verified: 2023-10
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central neryous system Progression Free Survival，CNS-PFS	3years	The interval from the start of treatment to the onset of disease progression or death from any cause in the intracranial lesions

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)for intracranial and extracranial lesions	3years	Percentage of patients with CompleteResponse (CR) and partial response (PartialResponse (PR)
Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions	3years	Percentage of patients with complete response, partial response, and StableDisease (SD)≥6 months
Overall survival (Oversall Survival, OS) and security	5years	The interval between the start of treatment and death from any cause

Trial Locations

Locations (1)

The Fifth Medical Center of PLA General Hospital; 🇨🇳 Beijing, Beijing, China