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New hope for breast cancer brain metastases: targeted drug Trop-2 ADC under study

NCT ID NCT07251868

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a drug called sacituzumab govitecan (Trop-2 ADC) in 100 breast cancer patients whose cancer has spread to the brain. Researchers want to see if the drug can shrink brain tumors and delay disease progression, while also monitoring side effects. The study collects data from routine care across multiple hospitals, without assigning patients to different treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sacituzumab govitecan (a Trop-2 antibody-drug conjugate)
What this could lead to
If successful, this could show that sacituzumab govitecan is an effective treatment option for breast cancer that has spread to the brain, potentially improving control of brain tumors.
What could go wrong
This is an early real-world study without a control group, so results may be less reliable. The drug may cause side effects, and not all patients may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with breast cancer and brain metastases, aged ≥18 years, who have received Sacituzumab Govitecan (SG).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 .

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

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