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

Sponsor

Beijing 302 Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06135194

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: T-DXd

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing	China	100071
2	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing	China	100071

Sponsors and Collaborators

Beijing 302 Hospital

Investigators

Study Director: tao wang, Beijing 302 Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing 302 Hospital

ClinicalTrials.gov Identifier:

NCT06135194

Other Study ID Numbers:

DS8021-Brain metastases

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Trastuzumab deruxtecan

Study Results

No Results Posted as of Nov 18, 2023