NCT06966141Recruiting
A Real World Study of Sacituzumab Govitecan
A Real World Study: Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 Negative Breast Cancer Patients
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 negative Breast Cancer Patients
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 2 May 2025
- Start date
- 5 Feb 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Fudan University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06966141
What you commit to
- Study type: Observational
- Planned participants: 100
- From 5 Feb 2025 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- Pregnant or lactating women;
- The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.