Breast CancerNCT07251868
Evaluation of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Real-World Study
An observational study of Breast Cancer and Brain Metastases From Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Brain Metastases From Breast Cancer, Trop2
- What is being tested?
- Sacituzumab Govitecan (SG)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer and brain metastases, aged ≥18 years, who have received Sacituzumab Govitecan (SG).
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Guohong Song, Doctor of Medicine (M.D.), 881211222066, songguohong918@hotmail.com
songguohong918@hotmail.com
About this study
Official title: Evaluation of Efficacy and Safety of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Multicenter Real-World Study
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).
Read more
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
- Being tested
- Sacituzumab Govitecan (SG)
- Keywords
- breast cancer, Brain metastases, Trop2, sacituzumab govitecan
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Govitecan (SG)Drug
Also called IMMU-132, Sacituzumab Govitecan-hziy
Sacituzumab Govitecan
| Study group | Role | What they receive |
|---|---|---|
| Patients received Trop-2 ADC （SG） | Advanced breast cancer patients with brain metastases who were treated with Sacituzumab Govitecan (SG). Receives: Drug: Sacituzumab Govitecan (SG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 48 months from the initiation of the study treatment.
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Start of treatment until 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohong Song, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251868
- Sponsor's protocol ID
- SG-BM-RWS
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Multicenter Real-World Study
- ClinicalTrials.gov ID
- NCT07251868
- Acronym / sponsor ID
- SG-BM-RWS
- Conditions
- Breast Cancer, Brain Metastases From Breast Cancer, Trop2
- Keywords
- breast cancer, Brain metastases, Trop2, sacituzumab govitecan
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients received Trop-2 ADC （SG） | – | Drug: Sacituzumab Govitecan (SG)Advanced breast cancer patients with brain metastases who were treated with Sacituzumab Govitecan (SG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer and brain metastases, aged ≥18 years, who have received Sacituzumab Govitecan (SG).
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab Govitecan (SG)Also: IMMU-132, Sacituzumab Govitecan-hziySacituzumab Govitecan | Drug | Patients received Trop-2 ADC （SG） |
Primary outcome
Real world progression free survival (rwPFS)
Time frame: up to 48 months from the initiation of the study treatment.
The time interval from the date of Sacituzumab Govitecan initiation until date of progressive disease (PD) or death from any causes, whichever occurred first.
5 secondary outcomes
Real world objective response rate (rwORR)
Time frame: approximately up to 24 weeks from the initiation of the study treatment.
Real world overall survival (rwOS)
Time frame: up to 48 months from the initiation of the study treatment.
Number of patients with adverse events
Time frame: approximately up to 68 weeks from the initiation of the treatment.
CNS-PFS
Time frame: Start of treatment until 2-year follow-up
CNS-ORR
Time frame: Start of treatment until 2-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Brain Metastases From Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guohong Song, Doctor of Medicine (M.D.) (0086-88121122-2066, songguohong918@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real world progression free survival (rwPFS) (time frame: up to 48 months from the initiation of the study treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.