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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 80 Years
Gender	Female

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06135194
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing 302 Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	tao wang
Principal Investigator Affiliation	Beijing 302 Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Recruiting

Address

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing, 100071

Site Contact

Tao Wang

[email protected]

01066947250