NCT06784921RecruitingNot Applicable
Real-World Patient Characteristics, Treatment Patterns, and Outcomes for Patients With HER2 Negative Metastatic Breast Cancer Treated With Sacituzumab Govitecan: A Retrospective Trial in China（SACIT-OUT）
Zhejiang Cancer Hospital1 site in 1 country200 target enrollmentStarted: February 1, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- PFS
Study Overview
Brief Summary
To investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.
Detailed Description
This study will conduct a multicenter, open, prospective clinical trial to investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
- •HER2-negative breast cancer(according to 2018 ASCO/CAP HER2 test guideline). 18-75 years old. ECOG PS 0～
- •life expectancy is not less than 12 weeks. at least one measurable lesion according to RECIST 1.
- •received at least two cycles of SG. Signed informed
Exclusion Criteria
- •Patients who did not receive sacituzumab govitecan treatment for two or more cycles Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
- •Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial History of neurological or psychiatric disorders Researchers believe that patients are not suitable for any other situation in this study.
Outcomes
Primary Outcomes
PFS
Time Frame: from enrollment to progression or death (for any reason),assessed up to 100 months
Progression-Free Survival
Secondary Outcomes
- Objective Response Rate(from enrollment to progression or death (for any reason), assessed up to 100 months)
- DoR(The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months)
- OS(from enrollment to death (for any reason).assessed up to 100 months)
Investigators
Wang Xiaojia
MD
Zhejiang Cancer Hospital
Study Sites (1)
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