Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-08-12
2027-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Patients received SG
HER2-negative breast cancer patients who received SG in the advanced stage
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. The Eastern Cooperative Oncology Group (ECOG) physical condition score of the United States is ≤2;
3. 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);
4. Receive gosatetuzumab treatment in the advanced stage;
5. During the study period, voluntarily abide by this trial protocol and receive regular follow-ups;
6. 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 Criteria
2. 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;
3. 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.
4. Those with mental illness or mental disorders, poor compliance and inability to cooperate and describe treatment responses;
5. 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;
6. Patients allergic to gosatetuzumab;
7. Patients who changed their treatment regimens after gosatetuzumab treatment due to non-disease progression reasons;
8. The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study.
18 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Jian Zhang,MD
Professor
Principal Investigators
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Jian Zhang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WONDER
Identifier Type: -
Identifier Source: org_study_id
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