Brain Metastasis From Advanced HER2-negative Breast CancerPhase 2NCT06839560
Evaluating the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis
A Phase 2 study testing Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy and Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy in people with Brain Metastasis From Advanced HER2-negative Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
A Prospective, multicenter, randomized controlled phase II study to evaluate the efficacy and safety of PD-L1 monoclonal antibody combined with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy and concurrent or delayed radiotherapy in patients with advanced HER2-negative breast cancer with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis From Advanced HER2-negative Breast Cancer
- What is being tested?
- Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy and Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 10 Sep 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females who are at least 18 years of age on the day of signing the informed consent form.
- Patients with metastatic HER2-negative breast cancer brain metastasis, with clear clinical documentation; specific criteria refer to the guidelines of the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP).
- Patients who have received no more than one line of chemotherapy during the metastatic stage of breast cancer.
- Patients with brain metastasis should not require immediate local therapy during the trial and meet at least one of the following criteria:
- The patient has not previously received intracranial radiotherapy.
- The patient has not previously undergone surgery for intracranial metastases; if surgery was performed, the surgical lesion is not the target for the planned radiotherapy, or it is the target lesion and has recurred after surgery.
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- The patient must have at least one measurable intracranial lesion, with the longest diameter baseline accurately measurable by magnetic resonance imaging (MRI) as ≥10 mm and suitable for precise repeated measurement according to RECIST 1.1 in combination with RANO criteria. Measurable extracranial lesions are not required.
- Patients with suspected or confirmed leptomeningeal metastasis should be excluded.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, assessed within 10 days before the start of study treatment.
- Patients may have previously received anthracycline (e.g., doxorubicin, epirubicin) and/or taxane (e.g., paclitaxel, docetaxel) therapy, specifically including:
- Before breast cancer recurrence, the patient received anthracycline and/or taxane during adjuvant or neoadjuvant treatment.
- The patient experienced treatment failure during or after anthracycline and/or taxane-based chemotherapy.
- In the judgment of the investigator, the patient is not suitable for anthracycline and/or taxane-based chemotherapy as a first-line treatment regimen.
- Female patients are not pregnant, not breastfeeding, and agree to use necessary contraceptive measures.
- The patient is able to sign the informed consent form to participate in the study.
- The patient has adequate organ function, as detailed in Table 1 of the study protocol; all screening laboratory tests should be completed within 10 days before the start of study treatment.
Who cannot join
- The subject has leptomeningeal metastasis.
- If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.
- Malabsorption syndrome, or the disease significantly affects gastrointestinal function; or after subtotal gastrectomy, or after proximal small bowel resection, which may affect the absorption of oral metronomic chemotherapy agents.
- The subject has dysphagia or is unable to swallow tablets.
- Known history of another invasive malignancy that is progressing or requires active treatment within the past 5 years. (Subjects with a history of cutaneous basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ of the breast treated with curative intent, or in situ cervical cancer are not excluded.)
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or targeted drugs acting on another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).
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- Diagnosis of immunodeficiency or receiving long-term systemic corticosteroid therapy (daily dose exceeding 10 mg prednisone equivalent) or any form of immunosuppressive therapy within 7 days before the first dose of study treatment.
- Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressive agents).
- History of pneumonia requiring steroid treatment (non-infectious) or current pneumonia.
- Positive urine pregnancy test within 72 hours before the first dose of study treatment.
- Active infection requiring systemic treatment.
- Known history of active tuberculosis.
- Echocardiogram performed at screening confirms left ventricular ejection fraction (LVEF) <50% or below the institutional lower limit of normal.
- Other significant cardiac disease, such as: myocardial infarction, acute coronary syndrome, or history of coronary artery angioplasty/stent placement/bypass surgery within the past 6 months; New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) or history of NYHA Class III or IV CHF.
- Known history of human immunodeficiency virus (HIV) infection.
- Known history of hepatitis B (defined as positive hepatitis B surface antigen [HBsAg]) or known active hepatitis C virus infection (defined as detectable HCV RNA [qualitative]).
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 100021
Beijing, Beijing Municipality, 100021
01087788060, drmafei@126.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis
A Prospective, multicenter, randomized controlled phase II study to evaluate the efficacy and safety of PD-L1 monoclonal antibody combined with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy and concurrent or delayed radiotherapy in patients with advanced HER2-negative breast cancer with brain metastasis
- Being tested
- Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy, Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab+VEX Metronomic Chemotherapy+Concurrent RadiotherapyDrug
- Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w).
- VEX Metronomic Chemotherapy: Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w).
- Radiotherapy: The interval between radiotherapy and immunotherapy should be within 3 weeks, with no specific order required. Different radiotherapy techniques will be selected based on the size and location of the metastatic lesions:
Stereotactic Body Radiation Therapy (SBRT), Spatially Fractionated Radiation Therapy (SFRT), Low-dose Radiotherapy (LDRT).
Adebrelimab+VEX Metronomic Chemotherapy+Delayed RadiotherapyDrug
- Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w).
- VEX Metronomic Chemotherapy: Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w).
- Radiotherapy:
If there is intracranial disease progression but extracranial disease remains stable, the systemic treatment regimen of Adelumab + VEX metronomic chemotherapy will be continued, with the addition of intracranial radiotherapy.
If there is intracranial disease progression and extracranial disease progression, the systemic treatment regimen will be modified, with the addition of intracranial radiotherapy.
The radiotherapy positioning and techniques will be the same as those used in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Concurrent Radiotherapy) | Experimental | 1. Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w).
2. VEX Metronomic Chemotherapy:
1) Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). 2) Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). 3) Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: The interval between radiotherapy and immunotherapy should be within 3 weeks, with no specific order required. Different radiotherapy techniques will be selected based on the size and location of the metastatic lesions:
1. Stereotactic Body Radiation Therapy (SBRT),
2. Spatially Fractionated Radiation Therapy (SFRT),
3. Low-dose Radiotherapy (LDRT). Receives: Drug: Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy |
| Control Group (Delayed Radiotherapy) | Active comparator | 1. Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w).
2. VEX Metronomic Chemotherapy:
1) Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). 2) Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: If there is intracranial disease progression but extracranial disease remains stable, the systemic treatment regimen of Adelumab + VEX metronomic chemotherapy will be continued, with the addition of intracranial radiotherapy.
If there is intracranial disease progression and extracranial disease progression, the systemic treatment regimen will be modified, with the addition of intracranial radiotherapy. The radiotherapy positioning and techniques will be the same as those used in the experimental group. Receives: Drug: Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Progression-Free Survival (iPFS)
According to RECIST 1.1 criteria：Disease Progression (PD): Referring to the smallest sum of the diameters of all measured target lesions throughout the entire experimental study, there is a relative increase of at least 20% in the sum of the diameters (if the baseline measurement is the smallest, then the baseline value is used as the reference); in addition, there must be an absolute increase of at least 5 mm in the sum of the diameters (the appearance of one or more new lesions is also considered disease progression).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Mar 2025
- Primary completion10 Sep 2028 (estimated)
- Study completion10 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastasis From Advanced HER2-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839560
- Sponsor's protocol ID
- NCC5108
- Status last verified
- Jun 2026
- First submitted
- 18 Feb 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis
- ClinicalTrials.gov ID
- NCT06839560
- Acronym / sponsor ID
- NCC5108
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 10 Sep 2028 (estimated)
- Study completion
- 10 Sep 2028 (estimated)
- First posted
- 21 Feb 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 Prospective, multicenter, randomized controlled phase II study to evaluate the efficacy and safety of PD-L1 monoclonal antibody combined with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy and concurrent or delayed radiotherapy in patients with advanced HER2-negative breast cancer with brain metastasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Concurrent Radiotherapy) | Experimental | Drug: Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy1. Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w). 2. VEX Metronomic Chemotherapy: 1) Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). 2) Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). 3) Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: The interval between radiotherapy and immunotherapy should be within 3 weeks, with no specific order required. Different radiotherapy techniques will be selected based on the size and location of the metastatic lesions: 1. Stereotactic Body Radiation Therapy (SBRT), 2. Spatially Fractionated Radiation Therapy (SFRT), 3. Low-dose Radiotherapy (LDRT). |
| Control Group (Delayed Radiotherapy) | Active comparator | Drug: Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy1. Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w). 2. VEX Metronomic Chemotherapy: 1) Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). 2) Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: If there is intracranial disease progression but extracranial disease remains stable, the systemic treatment regimen of Adelumab + VEX metronomic chemotherapy will be continued, with the addition of intracranial radiotherapy. If there is intracranial disease progression and extracranial disease progression, the systemic treatment regimen will be modified, with the addition of intracranial radiotherapy. The radiotherapy positioning and techniques will be the same as those used in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males or females who are at least 18 years of age on the day of signing the informed consent form.
- Patients with metastatic HER2-negative breast cancer brain metastasis, with clear clinical documentation; specific criteria refer to the guidelines of the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP).
- Patients who have received no more than one line of chemotherapy during the metastatic stage of breast cancer.
- Patients with brain metastasis should not require immediate local therapy during the trial and meet at least one of the following criteria:
- The patient must have at least one measurable intracranial lesion, with the longest diameter baseline accurately measurable by magnetic resonance imaging (MRI) as ≥10 mm and suitable for precise repeated measurement according to RECIST 1.1 in combination with RANO criteria. Measurable extracranial lesions are not required.
Key exclusion criteria (16 listed)
- The subject has leptomeningeal metastasis.
- If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.
- Malabsorption syndrome, or the disease significantly affects gastrointestinal function; or after subtotal gastrectomy, or after proximal small bowel resection, which may affect the absorption of oral metronomic chemotherapy agents.
- The subject has dysphagia or is unable to swallow tablets.
- Known history of another invasive malignancy that is progressing or requires active treatment within the past 5 years. (Subjects with a history of cutaneous basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ of the breast treated with curative intent, or in situ cervical cancer are not excluded.)
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 |
|---|---|---|
| Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy1. Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w). 2. VEX Metronomic Chemotherapy: Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: The interval between radiotherapy and immunotherapy should be within 3 weeks, with no specific order required. Different radiotherapy techniques will be selected based on the size and location of the metastatic lesions: Stereotactic Body Radiation Therapy (SBRT), Spatially Fractionated Radiation Therapy (SFRT), Low-dose Radiotherapy (LDRT). | Drug | Experimental Group (Concurrent Radiotherapy) |
| Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy1. Adebrelimab: 1200 mg on Day 1, every 3 weeks (q3w). 2. VEX Metronomic Chemotherapy: Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: If there is intracranial disease progression but extracranial disease remains stable, the systemic treatment regimen of Adelumab + VEX metronomic chemotherapy will be continued, with the addition of intracranial radiotherapy. If there is intracranial disease progression and extracranial disease progression, the systemic treatment regimen will be modified, with the addition of intracranial radiotherapy. The radiotherapy positioning and techniques will be the same as those used in the experimental group. | Drug | Control Group (Delayed Radiotherapy) |
Primary outcome
Intracranial Progression-Free Survival (iPFS)
Time frame: 24 months
According to RECIST 1.1 criteria：Disease Progression (PD): Referring to the smallest sum of the diameters of all measured target lesions throughout the entire experimental study, there is a relative increase of at least 20% in the sum of the diameters (if the baseline measurement is the smallest, then the baseline value is used as the reference); in addition, there must be an absolute increase of at least 5 mm in the sum of the diameters (the appearance of one or more new lesions is also considered disease progression).
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 10 Jun 2026.
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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?
A Phase 2 study testing Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy and Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy in people with Brain Metastasis From Advanced HER2-negative Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 16 inclusion and 16 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 10 Jun 2026. 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.
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 飞 马 (13910217780, drmafei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Progression-Free Survival (iPFS) (time frame: 24 months). 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 10 Jun 2026.