Evaluation of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Real-World Study

NCT ID: NCT07251868

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-12-31

Brief Summary

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

Conditions

Breast Cancer; Brain Metastases From Breast Cancer; Trop2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients received Trop-2 ADC （SG）

Advanced breast cancer patients with brain metastases who were treated with Sacituzumab Govitecan (SG).

Sacituzumab Govitecan (SG)

Intervention Type: DRUG

Sacituzumab Govitecan

Interventions

Sacituzumab Govitecan (SG)

Sacituzumab Govitecan

Intervention Type: DRUG

Other Intervention Names

IMMU-132; Sacituzumab Govitecan-hziy

Eligibility 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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Guohong Song

Chief Physician, Deputy Director of the Department, Medical Oncology of Breast Cancer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guohong Song, Doctor of Medicine (M.D.)

Role: CONTACT

songguohong918@hotmail.com

0086-88121122-2066

Facility Contacts

Guohong Song, Doctor of Medicine (M.D.)

Role: primary

songguohong918@hotmail.com

881211222066

Role: backup

songguohong918@hotmail.com

Other Identifiers

SG-BM-RWS

Identifier Type: -

Identifier Source: org_study_id