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The goal of this real-world study (RWS) is to evaluate the effectiveness of Trop-2 ADC (sacituzumab govitecan) in treating breast cancer patients with brain metastases, and to understand the safety profile of this drug in real clinical practice across multiple centers. The main questions it aims to answer are:
Does Trop-2 ADC (sacituzumab govitecan) improve intracranial outcomes in breast cancer patients with brain metastases (e.g., intracranial objective response rate, intracranial progression-free survival)? What types and rates of adverse events do breast cancer patients with brain metastases experience when receiving Trop-2 ADC (sacituzumab govitecan)? This is a multicenter real-world study, which will collect and analyze data from breast cancer patients with brain metastases who have received Trop-2 ADC (sacituzumab govitecan) in routine clinical care (no randomization or placebo control, consistent with real-world clinical scenarios).
Participants (breast cancer patients with brain metastases who received Trop-2 ADC) will have their data collected from:
Electronic health records (EHRs) across multiple medical centers Regular clinical follow-up visits (e.g., once every 4-8 weeks) for imaging assessments (to evaluate brain metastasis changes) and safety monitoring Medical records documenting treatment responses, disease progression, and any adverse events during treatment and follow-up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients received Trop-2 ADC (SG) | Advanced breast cancer patients with brain metastases who were treated with Sacituzumab Govitecan (SG). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab Govitecan (SG) | Drug | Sacituzumab Govitecan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real world progression free survival (rwPFS) | The time interval from the date of Sacituzumab Govitecan initiation until date of progressive disease (PD) or death from any causes, whichever occurred first. | up to 48 months from the initiation of the study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Real world objective response rate (rwORR) | The percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
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Inclusion Criteria:
Diagnosed with breast cancer via histopathological/cytopathological examination, with the diagnostic report issued by a tertiary hospital or the study-designated pathology center.
Exclusion Criteria:
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Patients with breast cancer and brain metastases, aged ≥18 years, who have received Sacituzumab Govitecan (SG).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guohong Song, Doctor of Medicine (M.D.) | Contact | 0086-88121122-2066 | songguohong918@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
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| approximately up to 24 weeks from the initiation of the study treatment. |
| Real world overall survival (rwOS) | Time from initiation of SG monotherapy or combination therapy to death from any cause | up to 48 months from the initiation of the study treatment. |
| Number of patients with adverse events | Adverse events were assessed during study treatment and at follow-up visits | approximately up to 68 weeks from the initiation of the treatment. |
| CNS-PFS | Central nervous system- progression free survival: time from the date when the subject first received SG to the first observation of tumor progression of central nervous system or death from any cause. | Start of treatment until 2-year follow-up |
| CNS-ORR | Central nervous system- objective response rate: proportion of subjects who achieved complete remission (CR) or partial remission (PR) of central nervous system by primary tumor imaging evaluation. | Start of treatment until 2-year follow-up |
| D017437 |
| Skin and Connective Tissue Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |