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To investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-Free Survival | from enrollment to progression or death (for any reason),assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Ratio of CR and PR in all subjects | from enrollment to progression or death (for any reason), assessed up to 100 months |
| DoR | Duration of Response |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event | Adverse events are described in terms of CTC AE 5.0 | from enrollment to 30 days after the last dose administrate |
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.
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Patient had a diagnosis of metastatic breast cancer, received at least two cycles of sacituzumab govitecan.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojia Wang, PhD | Contact | 13906500190 | wxiaojia0803@163.com | |
| Huanhuan ZHOU, MD | Contact | zhhuan77@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojia Wang, MD; Ph.D | Zhejiang Cancer Hospital | Principal Investigator |
| Qin Wu, Ph.D | Hangzhou Institute of Medicine (HIM) | Principal Investigator |
| Huanhuan Zhou, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Collect puncture tissue specimens before and after drug use for proteomics detection.
| The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months |
| OS | Overall Survival | from enrollment to death (for any reason).assessed up to 100 months |
| Zhejiang Cancer Hospital |
| Principal Investigator |
| D017437 |
| Skin and Connective Tissue Diseases |