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Breast Cancer MetastaticPhase 2NCT06975462

A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases

A Phase 2 study testing SHR-A1811 and radiotherapy in people with Breast Cancer Metastatic, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

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
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Trial summary

A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Metastatic
What is being tested?
SHR-A1811 and radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jun 2025to 1 Dec 2027
Phase
Phase 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed HER2 positive (IHC 3+ or IHC 2+/FISH+)or HER2-low(IHC1+ or 2+/FISH-) advanced breast cancer
  • Age>18 years.
  • newly diagnosed Brain metastases confirmed by enhanced brain MRI. Metastases number less than 6.
  • No more than four lines of previous advanced therapy
  • Life expectancy of more than 3 months
  • There were no known or suspected leptomeningeal brain metastases
Show all 10Show fewer
  • The interval from previous therapy was more than 2 weeks, and acute toxicity from previous therapy had to resolve to grade 1 or less
  • The use of mannitol, bevacizumab, or hormone therapy was allowed before enrollment, but the dose was stable for at least a week without the need for an increment
  • Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN) LVEF ≥ 50% QTcF < 480 ms INR≤1.5×ULN，APTT≤1.5×ULN 10.Signed the informed consent form prior to patient entry

Who cannot join

  • Leptomeningeal or hemorrhagic metastases
  • previously used T-dxd
  • Uncontrolled epilepsy
  • Severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc.
  • History of allergy to treatment regimens
  • Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
  • Inability to complete enhanced MRI
  • Not suitable for inclusion for specific reasons judged by sponsor -

Trial locations and contacts

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

Jing Yao contact

13971139665

jeaneyph@163.com

About this study

Official title: SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases: a Prospective，Sigle-arm，Phase II Study

A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases

Being tested
SHR-A1811 and radiotherapy
Keywords
breast cancer, barin metastases
Medical subject headings
Breast Neoplasms

What participants receive

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

  • SHR-A1811 and radiotherapyCombination product

    SHR-A1811:4.8mg/kg radiotherapy: 800cGY*5

Study groups in NCT06975462
Study groupRoleWhat they receive
SHR-A1811+radiotherapyExperimentalSHR-A1811:4.8mg/kg radiotherapy:800cGY*5
Receives: Combination Product: SHR-A1811 and radiotherapy

What is being measured

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

  1. The objective response rate of intracranial（IC-ORR）

    Proportion of participants with a complete response (CR) or partial response (PR) for intracranial tumors

    Measured: 2 years

Secondary outcomes (4)

  1. Intracranial CNS Progression Free Survival(IC-PFS)

    Time from treatment until the first date of intracranial disease progression or death due any cause. For participants whose disease has not progressed at the time of the analysis, censoring will be performed using the date of the last valid disease assessment.

    Measured: 2 years

  2. Progression Free Survival(PFS)

    Time from treatment until the first date of intracranial or extracranial disease progression or death due any cause. For participants whose disease has not progressed at the time of the analysis, censoring will be performed using the date of the last valid disease assessment.

    Measured: 2 years

  3. Overall survival(OS)

    Time from the treatment until to the date of death, regardless of the cause of death

    Measured: 3 years

  4. Adverse Events

    Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Dec 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06975462
Sponsor's protocol ID
UH-SHR A1811 and radiotherapy
Status last verified
Apr 2025
First submitted
9 May 2025
Last updated
16 May 2025
Results posted
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 2 study testing SHR-A1811 and radiotherapy in people with Breast Cancer Metastatic, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

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 8 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 16 May 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 phase mean?

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 Jing Yao (13971139665, jeaneyph@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The objective response rate of intracranial（IC-ORR） (time frame: 2 years). 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 NCT06975462.

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 16 May 2025.

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