Breast Cancer Metastatic
Conditions
Keywords
Breast cancer, Sacituzumab Govitecan
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.
Interventions
None listed
Sponsors
Zhejiang Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
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 0～2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | from enrollment to progression or death (for any reason),assessed up to 100 months | Progression-Free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse event | from enrollment to 30 days after the last dose administrate | Adverse events are described in terms of CTC AE 5.0 |
Countries
China
Contacts
Primary ContactXiaojia Wang, PhD
Backup ContactHuanhuan ZHOU, MD
Outcome results
None listed