AzTrials
AzTrials

Breast CancerPhase 1/2NCT07177950

A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases

A Phase 1/2 study testing SHR-A1811 and radiotherapy in people with Breast Cancer and Brain Metastases, run by Peking University Cancer Hospital & Institute.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multi-center, open-label, two-cohort study. The purpose of this study is to evaluate the safety, tolerability and efficacy of SHR-A1811 in the treatment of HER2-positive breast cancer with brain and leptomeningeal metastases, and the efficacy and safety of SHR-A1811 in the treatment of HER2-positive breast… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
SHR-A1811 and radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
No sites listed yet
Study dates
30 Sep 2025to 30 Sep 2029
Phase
Phase 1/2
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women aged 18-75 years (inclusive).
  • Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification).
  • Radiologically documented brain metastases, with or without baseline leptomeningeal disease:
  • Cohort A (leptomeningeal metastasis cohort): leptomeningeal involvement demonstrated by contrast-enhanced MRI or positive cerebrospinal fluid (CSF) cytology.
  • Cohort B (no leptomeningeal metastasis cohort): ≥1 measurable intracranial lesion; either CNS-naïve or progressive after prior local therapy.
  • Anticipated life expectancy >12 weeks.
Show all 15Show fewer
  • ECOG performance status 0-2.
  • Adequate organ function as defined by the following laboratory criteria:
  • Hematologic: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count (PLT) ≥100 × 10⁹/L, hemoglobin (HGB) ≥90 g/L.
  • Hepatic: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) (≤5 × ULN in patients with liver metastases); total serum bilirubin (TBIL) ≤1.5 × ULN; serum albumin ≥30 g/L.
  • Renal: serum creatinine (Cr) ≤1.5 × ULN or calculated creatinine clearance ≥50 mL/min using the Cockcroft-Gault formula.
  • Coagulation: prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 × ULN.
  • Cardiac: left ventricular ejection fraction (LVEF) ≥50%.
  • Negative serum pregnancy test; women of childbearing potential must use a highly effective contraceptive method from study initiation until at least 6 months after the last dose of study medication.
  • Voluntary participation with written informed consent obtained prior to any study-related procedures.

Who cannot join

  • Cohort A participants must be excluded if any of the following apply:
  • Cerebrospinal fluid (CSF) circulation obstruction that cannot be adequately controlled by therapeutic measures.
  • MRI evidence of nodular leptomeningeal (LM) disease in the setting of negative CSF cytology.
  • Active central nervous system (CNS) infection.
  • Clinically significant coagulopathy.
  • Cohort B participants must be excluded if leptomeningeal metastasis is documented, defined as either: radiographic evidence of leptomeningeal involvement, or positive CSF cytology, or unequivocal clinical signs or symptoms attributable to leptomeningeal disease.
Show all 14Show fewer
  • Presence of clinically significant third-space fluid accumulation (e.g., massive pleural or peritoneal effusion) that cannot be adequately controlled by drainage or other interventions.
  • Known hypersensitivity to any study drug or its excipients, or to any prior humanized monoclonal antibody products (e.g., trastuzumab, pertuzumab).
  • Prior or current exposure to antibody-drug conjugates (ADCs) containing a topoisomerase I inhibitor, including but not limited to fam-trastuzumab deruxtecan (DS-8201a).
  • Clinically significant cardiovascular disease, including but not limited to: severe or unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association class ≥ II), clinically relevant supraventricular or ventricular arrhythmias requiring therapy or intervention, myocardial infarction within 6 months prior to first study dose, or cerebrovascular accident (including transient ischemic attack).
  • Participants known or suspected to interstitial lung disease.
  • Concurrent participation in any other interventional drug clinical trial.
  • Refusal to comply with protocol-mandated follow-up.
  • Presence of any additional severe physical or psychiatric disorder, or any laboratory abnormality that, in the investigator's judgment, could increase the subject's risk, confound study results, or render the patient unsuitable for enrollment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Bin Shao contact

+86-010-88196380

shaobin79@aliyun.com

About this study

Official title: A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases, With or Without Leptomeningeal Metastases.

This is a multi-center, open-label, two-cohort study. The purpose of this study is to evaluate the safety, tolerability and efficacy of SHR-A1811 in the treatment of HER2-positive breast cancer with brain and leptomeningeal metastases, and the efficacy and safety of SHR-A1811 in the treatment of HER2-positive breast cancer with brain but without leptomeningeal metastases.

Being tested
SHR-A1811, radiotherapy
Keywords
HER2-positive breast cancer, SHR-A1811
Medical subject headings
Breast Neoplasms, Brain Neoplasms, Meningeal Carcinomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-A1811Drug

    Systemic therapy: 4.8 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.

  • SHR-A1811Drug

    Intrathecal therapy: Administered intrathecally on Day 1 of each cycle. Dose escalation follows a Bayesian Optimal Interval (BOIN) design with three predefined dose levels-15 mg, 30 mg, and 40 mg. The starting dose level is 15 mg. Patients are enrolled in cohorts of three per dose level. If no dose-limiting toxicities (DLTs) are observed, escalation proceeds to the next higher dose level according to the BOIN algorithm. Treatment is administered for a minimum of two cycles and is continued until cerebrospinal fluid (CSF) cytology achieves negative conversion, completion of six cycles, or intolerable adverse events, whichever occurs first. Extension beyond six cycles may be permitted following investigator's discussion and must be documented with justification.

  • radiotherapyRadiation

    radiotherapy is determined by investigator's choice

Study groups in NCT07177950
Study groupRoleWhat they receive
Arm 1ExperimentalSystemic SHR-A1811 therapy combined with intrathecal SHR-A1811 therapy
Receives: Drug: SHR-A1811
Arm 2ExperimentalSystemic SHR-A1811 therapy combined with radiotherapy
Receives: Drug: SHR-A1811; Radiation: radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Number of Dose-Limiting Toxicities (DLTs) in the Sequential Dose-Escalation Cohort

    For cohort A. DLT is defined as any of the following events judged by the investigator to be related or possibly related to SHR-A1811 occurring within Cycle 1 (21 days), graded according to NCI-CTCAE v5.0:

    1. Grade ≥3 neurologic toxicity;
    2. Any death unless unequivocally attributable to tumor progression or an unrelated exogenous cause.

    Measured: Start of treatment until 3-week follow-up

  2. CNS-PFS

    For cohort B: Central nervous system- progression free survival: time from the date when the subject first received SHR-A1811 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

Secondary outcomes (6)

  1. CNS-PFS

    For cohort A: Central nervous system- progression free survival: time from the date when the subject first received SHR-A1811 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

  2. CNS-ORR

    For cohort B. 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

  3. PFS

    Progression free survival: time from the date when the subject first received SHR-A1811 to the first observation of tumor progression or death from any cause.

    Measured: Start of treatment until 2-year follow-up

  4. OS

    Overall survival: time from the date when the subject first received SHR-A1811 to death from any cause.

    Measured: Start of treatment until 2-year follow-up

  5. Quality of life score

    Evaluated by the quality of life core scale [EORTC QLQ-C30 (Chinese version)] developed by European cancer research and treatment organization. The scope of each domain is 0 to 100. Higher scores in the functional and general health areas indicate better functional status and quality of life, and higher scores in the symptomatic areas indicate more symptoms or problems (poorer quality of life).

    Measured: Start of treatment until 2-year follow-up

  6. Incidence and severity of adverse events (AE) and serious adverse events (SAE)

    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.

  1. First posted17 Sep 2025
  2. Study start30 Sep 2025 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07177950
Sponsor's protocol ID
MA-BC-II-113
Status last verified
Sep 2025
First submitted
2 Sep 2025
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-A1811 and radiotherapy in people with Breast Cancer and Brain Metastases, run by Peking University Cancer Hospital & Institute.

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 15 inclusion and 14 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: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Bin Shao (+86-010-88196380, shaobin79@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Number of Dose-Limiting Toxicities (DLTs) in the Sequential Dose-Escalation Cohort (time frame: Start of treatment until 3-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07177950.

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 17 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in