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

Breast Cancer Clinical Trial

Official title:

Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135194
• Other study ID #: DS8021-Brain metastases
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Beijing 302 Hospital
• Contact: jinmei zhou
• Phone: 010-66947250
• Email: jinzhu2714[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• T-DXd
Efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib

Locations

Country	Name	City	State
China	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing
China	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central neryous system Progression Free Survival,CNS-PFS	The interval from the start of treatment to the onset of disease progression or death from any cause in the intracranial lesions	3years
Secondary	Overall Response Rate (ORR)for intracranial and extracranial lesions	Percentage of patients with CompleteResponse (CR) and partial response (PartialResponse (PR)	3years
Secondary	Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions	Percentage of patients with complete response, partial response, and StableDisease (SD)=6 months	3years
Secondary	Overall survival (Oversall Survival, OS) and security	The interval between the start of treatment and death from any cause	5years