Status:
ACTIVE_NOT_RECRUITING
A ReaL World Study of DS-8201
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer Metastatic
Treatment Efficacy
Eligibility:
All Genders
18+ years
Brief Summary
A ReaL world study of DS-8201
Eligibility Criteria
Inclusion
- Male or female aged 18 or above;
- The Eastern Cooperative Oncology Group (ECOG) physical condition score of the United States is ≤2;
- HER2 positive (IHC 3+ or IHC 2+ and ISH+) confirmed by tumor histology or cytology, and having received one or more anti-HER2 drug treatments previously; Or low expression of HER2 confirmed by tumor histology or cytology (IHC 1+ or IHC 2+ and ISH-), and having received at least one systemic treatment in the metastatic disease stage previously, or unresectable or metastatic breast cancer that relapsed during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy;
- Receive goldtrastuzumab treatment in the advanced stage;
- During the study period, voluntarily abide by this trial protocol and receive regular follow-ups;
- All women of childbearing age, fertile men or their spouses who have no plans for fertility or sperm donation throughout the trial period until 6 months after the last dose, or who voluntarily take effective contraceptive measures.
Exclusion
- Pregnant or lactating women;
- Those with acute or chronic infections, or those with other serious diseases at the same time, are judged by the researchers as unsuitable for this study;
- Having suffered from other malignant tumors within 5 years (excluding the following situations: cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma; A second primary cancer that has been completely cured and has no recurrence within five years; Researchers have clearly identified which primary tumor source the metastatic foci belong to.
- Those with mental illness or mental disorders, poor compliance and inability to cooperate and describe treatment responses;
- Those with severe organic diseases or major organ failure, such as decompensated heart, lung, liver or kidney failure, which makes them unable to tolerate treatment;
- Patients allergic to trastuzumab;
- Patients who changed their treatment regimens after trastuzumab treatment due to reasons other than disease progression or intolerable adverse reactions;
- The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06945224
Start Date
December 1 2024
End Date
June 30 2025
Last Update
April 25 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer center
Shanghai, China, China, 200032