Sacituzumab govitecan (Trop-2 ADC) for breast cancer that has spread to the brain
Evaluation of Efficacy and Safety of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Multicenter Real-World Study
This real-world project will try sacituzumab govitecan (a Trop‑2 antibody–drug conjugate) in adults with breast cancer brain metastases to see if it improves control of brain tumors and how safe it is in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | Sacituzumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07251868 on ClinicalTrials.gov |
What this trial studies
This multicenter observational real‑world study will collect treatment records and follow‑up data from adults with pathologically confirmed breast cancer who developed brain metastases and received sacituzumab govitecan in routine clinical practice. There is no randomization or placebo; investigators will extract intracranial outcomes such as intracranial objective response rate and intracranial progression‑free survival, along with systemic and neurologic adverse events. Data will be pooled across participating centers to describe effectiveness and safety patterns in a diverse clinical population. Findings are intended to complement prospective trials by reflecting real‑life use, dosing, and patient selection.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed breast cancer and documented brain metastases who have received sacituzumab govitecan at a participating center and have complete, traceable medical records are the intended participants.
Not a fit: Patients who have not received sacituzumab govitecan, who lack complete treatment or follow‑up records, or whose brain disease requires immediate neurosurgical or radiotherapeutic intervention are unlikely to gain direct benefit from this observational data collection.
Why it matters
Potential benefit: If positive, the study could support sacituzumab govitecan as an additional treatment option that helps control brain metastases and provides real‑world safety information for clinicians.
How similar studies have performed: Clinical trials and case series have shown systemic activity of sacituzumab govitecan in metastatic breast cancer, but evidence for intracranial benefit is limited and largely comes from small reports and subgroup analyses.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 via histopathological/cytopathological examination, with the diagnostic report issued by a tertiary hospital or the study-designated pathology center. * 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. * No restrictions on the number, size of brain metastatic lesions, presence of meningeal metastasis, or presence of brain metastasis-related symptoms (e.g., headache, limb dysfunction). * Previous treatment with Sacituzumab Govitecan (SG), with clear medication records (prescription orders, medical orders, pharmacy dispensing records, etc.), and no restrictions on the line of SG treatment, dosage, or treatment cycles (both completion of full-cycle treatment and early discontinuation due to adverse reactions/progression are acceptable). * No restriction on the start time of SG treatment ; patients currently receiving SG treatment, who have completed SG treatment, or who have discontinued SG treatment due to objective reasons are all eligible. * Stable vital signs at present, without the following uncontrolled severe conditions: ① Severe infections such as sepsis and severe pneumonia (symptoms relieved and laboratory indicators normalized after anti-infective treatment); ② Epileptic seizures within the past 3 months (or uncontrolled without standardized anti-epileptic treatment); ③ Failure of major organs such as heart, liver, and kidney (e.g., New York Heart Association (NYHA) Class Ⅳ cardiac function, Child-Pugh Class C liver function, chronic kidney disease Stage 5) . * The patient/guardian can cooperate with study follow-up (outpatient follow-up, telephone follow-up, electronic medical record extraction, etc.), and survival status, disease progression, subsequent treatment, adverse reactions, and other information can be obtained within the expected follow-up period. Exclusion Criteria: * 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 .
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Guohong Song, Doctor of Medicine (M.D.)
- Email: songguohong918@hotmail.com
- Phone: 0086-88121122-2066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.