Status:
RECRUITING
A Real World Study of Sacituzumab Govitecan
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer Metastatic
Treatment Outcome
Eligibility:
All Genders
18+ years
Brief Summary
Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 negative Breast Cancer Patients
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;
- Unresectable or metastatic triple-negative breast cancer confirmed by tumor histology or cytology, and having received at least two systemic treatments previously (at least one of which was for metastatic disease); Or HR+/HER2- (IHC 0, 1+ or IHC 2+/ISH-) unresectable or metastatic breast cancer confirmed by tumor histology or cytology, with previous endocrine therapy and ≥2 lines of systemic therapy (for metastatic disease);
- Receive gosatetuzumab 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 gosatetuzumab;
- Patients who changed their treatment regimens after gosatetuzumab treatment due to non-disease progression reasons;
- The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study.
Key Trial Info
Start Date :
August 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06966141
Start Date
August 12 2024
End Date
August 1 2027
Last Update
May 11 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032