Evaluation of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Real-World Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years old (based on actual age at the time of signing the informed consent form), with no restriction on gender
Able to understand the study purpose, risks, and benefits, and voluntarily sign the written informed consent form; if the patient has cognitive impairment or is unable to express themselves independently, their legal guardian/authorized agent shall sign after being fully informed, and provide valid authorization documents.
Have access to complete medical records (including breast cancer primary lesion diagnosis data, brain metastasis diagnosis data, SG treatment records, follow-up data, etc.) in the study collaborating medical institutions/specified medical systems to ensure traceability of treatment processes and outcomes.
Diagnosed with breast cancer brain metastasis based on meeting any of the following conditions: ① Definitive diagnosis by a physician with associate senior title or above, combining contrast-enhanced cranial magnetic resonance imaging (MRI)/computed tomography (CT) with clinical symptoms and signs; ② Postoperative pathology of brain metastatic lesions confirming breast cancer metastasis; ③ Pathological examination of brain metastatic lesion biopsy specimens confirming breast cancer metastasis.
Disqualifiers
Complicated with other primary malignant tumors (excluding breast cancer), and the tumor was in an active stage within the past 5 years (not achieving complete remission or disease-free survival for more than 5 years).
Unable to cooperate with informed consent or follow-up due to mental illness, cognitive impairment, etc., and without qualified guardian assistance.
Concurrent participation in other interventional clinical trials (e.g., randomized controlled trials), which may affect data collection and result interpretation of this study.
Other conditions judged by the researcher to affect study quality or patient safety .
Trial population
Patients with breast cancer and brain metastases, aged ≥18 years, who have received Sacituzumab Govitecan (SG).
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Sacituzumab Govitecan (SG)
DrugSacituzumab Govitecan
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Patients received Trop-2 ADC （SG）1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 48 months from the initiation of the study treatment.Secondary outcomes
1
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.
Time frame
approximately up to 24 weeks from the initiation of the study treatment.2
Real world overall survival (rwOS)
Time from initiation of SG monotherapy or combination therapy to death from any cause
Time frame
up to 48 months from the initiation of the study treatment.3
Number of patients with adverse events
Adverse events were assessed during study treatment and at follow-up visits
Time frame
approximately up to 68 weeks from the initiation of the treatment.4
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.
Time frame
Start of treatment until 2-year follow-upSponsors and contacts
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Source ClinicalTrials.gov