Actively Recruiting
A Real World Study: Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 Negative Breast Cancer Patients
Led by Fudan University · Updated on 2025-05-11
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate clinical outcomes and safety of Sacituzumab Govitecan in patients with metastatic HER2-negative breast cancer. It focuses on patients who have advanced stage disease and have previously received systemic treatments. The study is observational and sponsored by Fudan University, aiming to gather real-world data on this treatment's use in this patient group. Patients included in the study are those with unresectable or metastatic triple-negative breast cancer or HR+/HER2- breast cancer who have received multiple prior therapies. They receive Sacituzumab Govitecan during the advanced stage of their disease. The study monitors their treatment outcomes and collects data without altering standard care. Participants will be followed regularly according to the study protocol, with assessments including progression-free survival measured six months after the last patient enrollment and overall response rate measured up to 12 weeks. The study also includes safety monitoring and requires adherence to contraceptive measures for those of childbearing potential. The total study duration extends until August 2027.
CONDITIONS
Brief Title
A Real World Study of Sacituzumab Govitecan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 or above
- ECOG physical condition score of 2 or less
- Unresectable or metastatic triple-negative breast cancer confirmed by tumor tests, with at least two prior systemic treatments (including one for metastatic disease)
- Or HR+/HER2- unresectable or metastatic breast cancer confirmed by tumor tests, with previous endocrine therapy and at least two lines of systemic therapy for metastatic disease
- Receiving Sacituzumab Govitecan treatment in the advanced stage
- Willing to follow the trial protocol and attend regular follow-ups during the study period
- Women of childbearing age, fertile men, or their partners must agree to use effective contraception or have no plans for fertility or sperm donation during the trial and for six months after the last dose
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients with acute or chronic infections or other serious diseases deemed unsuitable by researchers
- History of other malignant tumors within five years except certain cured cancers or fully cured second primary cancers without recurrence
- Patients with mental illness, poor compliance, or inability to cooperate in treatment assessments
- Patients with severe organ diseases or major organ failure making treatment intolerable
- Patients allergic to Sacituzumab Govitecan
- Patients who changed treatment after Sacituzumab Govitecan for reasons other than disease progression
- Any other conditions judged by researchers to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 weeks
Participants who receive Sacituzumab Govitecan treatment in the advanced stage are observed to assess clinical outcomes and safety.
Regular visits during treatment period
Duration - Six months after the last patient was enrolled
Participants are followed for progression-free survival and safety up to six months after the last patient enrollment.
Periodic follow-up visits
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jian Zhang, MD,PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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