Breast CancerNCT07117864
Exploration of the Safety and Efficacy of T-DXd Concurrent With Brain Radiotherapy in Patients With Brain Metastases HER2-positive/HER2-low Advanced Breast Cancer
A study testing T-DXd concurrent brain radiotherapy in people with Breast Cancer, run by QIAO LI at 1 site in China.
Trial summary
A study on the safety and efficacy of T-DXd in combination with local radiotherapy for brain metastases in HER2-Positive and HER2-Low breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- T-DXd concurrent brain radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Jul 2026
- Phase
- Interventional
- 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
- Female patients aged ≥18 and ≤75 years with histologically confirmed breast cancer.
- ECOG performance status of 0 to 2.
- HER2-positive or HER2-low invasive breast cancer, defined as:
- HER2-positive: IHC 3+ or IHC 2+ with FISH amplification; HER2-low: IHC 2+ without FISH amplification, or IHC 1+.
- Confirmed diagnosis of breast cancer brain metastases.
- Patients may have received prior chemotherapy (from first-line to multiple lines), HER2-targeted therapy (monoclonal antibodies), endocrine therapy, and immunotherapy.
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- Adequate organ function as defined below:
- Hematology:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 80 × 10⁹/L (no blood transfusion within 14 days prior to first dose); Hemoglobin (Hb) ≥ 80 g/L;
- Serum biochemistry:
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN) and serum creatinine ≤ 1.5 × ULN;
- Cardiac function:
- Echocardiography: Left ventricular ejection fraction (LVEF) ≥ 45%.
- Subjects must voluntarily participate in the study and provide signed informed consent.
Who cannot join
- Tumor-Related Symptoms and Treatments
- Uncontrolled moderate to large pleural effusion, ascites, or pericardial effusion requiring repeated drainage;
- Imaging (CT or MRI) showing tumor invasion of major blood vessels, or cases deemed by the investigator as highly likely to cause fatal hemorrhage due to vascular invasion during the study period;
- Signs of meningeal irritation such as neck stiffness, seizures, or cognitive impairment, or confirmed leptomeningeal metastasis by imaging (CT or MRI) or lumbar puncture;
- Uncontrolled or symptomatic hypercalcemia (defined as ionized calcium > 1.5 mmol/L, serum calcium > 12 mg/dL, or albumin-corrected serum calcium > ULN), or symptomatic hypercalcemia requiring continued bisphosphonate treatment;
- Prior cranial radiotherapy;
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- Prior treatment with trastuzumab deruxtecan (T-DXd).
- Comorbidities / Medical History
- History of other malignancies for which the patient received any systemic anti-cancer therapy or local treatment (including surgery or radiotherapy), except for adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin;
- Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from such surgery (diagnostic biopsies and PICC line placement are permitted);
- Known or suspected autoimmune diseases, except for the following conditions:
- Hypothyroidism due to autoimmune thyroiditis managed with hormone replacement therapy; Stable Type I diabetes mellitus with controlled blood glucose;
- Presence of interstitial lung disease (ILD), non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia);
- HIV infection or known AIDS; active hepatitis (HBV defined as HBV-DNA ≥ 500 IU/mL; HCV defined as HCV-RNA above the lower limit of detection); concurrent HBV and HCV infection; autoimmune hepatitis;
- Severe infections within 4 weeks before first dose (e.g., bacteremia or severe pneumonia requiring hospitalization), or active infections requiring systemic antibiotic therapy of CTCAE grade ≥2 within 2 weeks before first dose, or unexplained fever >38.5°C during screening or prior to first dose (fever deemed tumor-related may be eligible at the investigator's discretion); evidence of active tuberculosis within 1 year prior to first dose;
- Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
- Severe or uncontrolled cardiovascular disease, including but not limited to:
- History of heart failure or systolic dysfunction (LVEF < 45%); High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate > 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular (AV) block (e.g., Mobitz type II second-degree or third-degree AV block); Angina requiring anti-anginal medications; Clinically significant valvular heart disease; Transmural myocardial infarction on ECG; Poorly controlled hypertension (systolic BP >180 mmHg and/or diastolic BP >100 mmHg);
- Known hypersensitivity to the investigational drug or any of its excipients, or a history of severe hypersensitivity reactions to other monoclonal antibodies.
- Pregnant or breastfeeding women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential unwilling to use effective contraception during the study.
- History of confirmed neurological or psychiatric disorders, including epilepsy or dementia; known history of psychiatric medication abuse, alcoholism, or substance abuse.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
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
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Qiao Li, MD, 86-87788820, liqiaopumc@qq.com
About this study
A study on the safety and efficacy of T-DXd in combination with local radiotherapy for brain metastases in HER2-Positive and HER2-Low breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- T-DXd concurrent brain radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-DXd concurrent brain radiotherapyCombination product
T-DXd：5.4mg/kg ivgtt Q3w SRT/WBRT
| Study group | Role | What they receive |
|---|---|---|
| T-DXd concurrent brain radiotherapy | Experimental | T-DXd：5.4mg/kg ivgtt Q3w SRT/WBRT Receives: Combination Product: T-DXd concurrent brain radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain progression-free survival
brain progression-free survival
Measured: At the end of Cycle 1(each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Jul 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QIAO LI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, QIAO LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Qiao Li, MD, Study director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117864
- Sponsor's protocol ID
- 24/376-4656
- Other IDs
- NCC4774
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Safety and Efficacy of T-DXd Concurrent With Brain Radiotherapy in Patients With Brain Metastases HER2-positive/HER2-low Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07117864
- Acronym / sponsor ID
- 24/376-4656
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- QIAO LIUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 12 Aug 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.
A study on the safety and efficacy of T-DXd in combination with local radiotherapy for brain metastases in HER2-Positive and HER2-Low breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T-DXd concurrent brain radiotherapy | Experimental | Combination Product: T-DXd concurrent brain radiotherapyT-DXd：5.4mg/kg ivgtt Q3w SRT/WBRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female patients aged ≥18 and ≤75 years with histologically confirmed breast cancer.
- ECOG performance status of 0 to 2.
- HER2-positive or HER2-low invasive breast cancer, defined as:
- HER2-positive: IHC 3+ or IHC 2+ with FISH amplification; HER2-low: IHC 2+ without FISH amplification, or IHC 1+.
- Confirmed diagnosis of breast cancer brain metastases.
Key exclusion criteria (22 listed)
- Tumor-Related Symptoms and Treatments
- Comorbidities / Medical History
- Hypothyroidism due to autoimmune thyroiditis managed with hormone replacement therapy; Stable Type I diabetes mellitus with controlled blood glucose;
- History of heart failure or systolic dysfunction (LVEF < 45%); High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate > 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular (AV) block (e.g., Mobitz type II second-degree or third-degree AV block); Angina requiring anti-anginal medications; Clinically significant valvular heart disease; Transmural myocardial infarction on ECG; Poorly controlled hypertension (systolic BP >180 mmHg and/or diastolic BP >100 mmHg);
- Known hypersensitivity to the investigational drug or any of its excipients, or a history of severe hypersensitivity reactions to other monoclonal antibodies.
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 |
|---|---|---|
| T-DXd concurrent brain radiotherapyT-DXd：5.4mg/kg ivgtt Q3w SRT/WBRT | Combination product | T-DXd concurrent brain radiotherapy |
Primary outcome
brain progression-free survival
Time frame: At the end of Cycle 1(each cycle is 21 days)
brain progression-free survival
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 12 Aug 2025.
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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.
Qiao Li, MD study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-DXd concurrent brain radiotherapy in people with Breast Cancer, run by QIAO LI 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 14 inclusion and 22 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 12 Aug 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 Qiao Li, MD (86-87788820, liqiaopumc@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain progression-free survival (time frame: At the end of Cycle 1(each cycle is 21 days)). 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 12 Aug 2025.