To Investigate the Real-world Efficacy and Safety of Sacituzumab Govitecan for HER2 Negative Metastatic Breast Cancer Patients in China.

Not yet recruiting

• Conditions: Breast Cancer Metastatic

• Registration Number: NCT06784921
• Lead Sponsor: Zhejiang Cancer Hospital

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 Timeline

• Status Verified: 2024-01
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Study Start: 2025-02-01
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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 0～2. life expectancy is not less than 12 weeks. at least one measurable lesion according to RECIST 1.1. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS	from enrollment to progression or death (for any reason),assessed up to 100 months	Progression-Free Survival

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	from enrollment to progression or death (for any reason), assessed up to 100 months	Ratio of CR and PR in all subjects
DoR	The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months	Duration of Response
OS	from enrollment to death (for any reason).assessed up to 100 months	Overall Survival