A Real World Study of Sacituzumab Govitecan

Launched by FUDAN UNIVERSITY · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Sacituzumab Govitecan for patients with metastatic breast cancer, particularly those whose cancer has spread and is not responding to standard treatments. The goal is to learn more about how well this treatment works and how safe it is for patients. They are currently looking for participants aged 18 and older, including both men and women, who have been diagnosed with either triple-negative breast cancer or hormone receptor-positive breast cancer that cannot be surgically removed. To qualify, participants should have already tried at least two other treatments for their cancer.

If you decide to participate, you will receive the study treatment and have regular check-ups to monitor your health and response to the medication. It’s important to note that pregnant or breastfeeding women, those with certain serious health conditions, or those with specific allergies may not be eligible for this trial. This study is a great opportunity for patients seeking new treatment options and contributes to understanding how to better help those battling advanced breast cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female aged 18 or above;
• • 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:
• • 1. Pregnant or lactating women;
• • 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.