Central Nervous System (CNS) MetastasesBCBM006NCT07653893
A Phase II Observational Clinical Study on the Relationship Between Cerebrospinal Fluid Drug Concentration and Efficacy of Trastuzumab Deruxtecan in Central Nervous System Metastatic Breast Cancer
An observational study of Central Nervous System (CNS) Metastases and Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Approximately 5-15% breast cancer patients develop brain metastases. Current local treatments (surgery/radiotherapy) are associated with significant complications, and systemic treatments have limited efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System (CNS) Metastases, Breast Cancer
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2025to Jun 2028
- How long will I take part?
- 28 Days
- Phase
- Observational
- 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
Study population: The study population consisted of patients with recurrent metastatic breast cancer, divided into a control cohort without central nervous system metastases (N=10) and an experimental cohort with central nervous system metastases (N=30-50). Ptients in China
Who may be able to join
- 1. ≥18 years（2007-06）, any gender. 2. ECOG Performance Status 0-2. 3. Evidence of local recurrence or metastatic breast cancer not amenable to curative surgery or radiotherapy, and planned for intravenous trastuzumab deruxtecan treatment.
- 4. Expected survival time ≥8 weeks. 5. Provision of sufficient fresh tissue specimen or ≥10 unstained slides of tumor sample (primary and/or metastatic site) for biomarker analysis prior to treatment (intracranial metastatic lesion specimens preferred).
- 6. Cohort 2 (Experimental Cohort): Presence of brain parenchymal metastases confirmed by contrast-enhanced brain MRI, with at least one measurable brain lesion not previously irradiated, evaluable per RECIST 1.1 criteria.
- 7. Patients receiving mannitol, steroids, or anticonvulsant therapy prior to the first dose are eligible if the drug doses are stable for at least one week without requiring an increase, and neurological symptoms are stable for ≥1 week.
- 8. Organ function levels must meet the following requirements:
- Hematology:
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- ANC≥1.5×109/L;
- PLT≥75×109/L;
- Hb≥90 g/L (allowing blood transfusion or medication to ensure hemoglobin content);
- Coagulation function: APTT≤1.5×ULN；PT≤1.5×ULN;
- Blood Chemistry:
- TBIL≤1.5×ULN;
- ALT and AST≤3×ULN (≤ 5.0×ULN for liver metastases);
- Creatinine ≤1.5 × ULN or Creatinine Clearance ≥50 mL/min (Cockcroft-Gault formula);
- Cardiac Ultrasound: LVEF ≥50%;
- 12-Lead ECG: Fridericia-corrected QT interval (QTcF) <470 ms for females, <450 ms for males; 9. Voluntary participation in this study, signed informed consent, good compliance, and willingness to cooperate with follow-up.
Who cannot join
- 1. Presence of uncontrolled third-space fluid accumulation (e.g., large pleural effusion or ascites) not manageable by drainage or other methods, deemed unsuitable for enrollment by the investigator.
- 2. Previous treatment with an anti-HER2 ADC drug carrying the same payload resulting in resistance. Patients who discontinued prior ADC therapy for other reasons, including but not limited to toxicity, are eligible.
- 3. Adverse reactions from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v5.0 (except for ≤ Grade 2 toxicities judged by the investigator as having no safety risk, such as alopecia or long-term toxicities from radiotherapy).
- 4. History of other malignancies within the past 5 years, excluding cured carcinoma in situ of the cervix, basocellular skin carcinomas, or cutaneous squamous cell carcinoma.
- 5. History of severe cardiovascular or cerebrovascular diseases, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities requiring clinical intervention, such as ventricular arrhythmia, II-III degree atrioventricular block, etc.
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- Cardiac insufficiency of Class III~IV according to the New York Heart Association (NYHA) criteria.
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular/cerebrovascular events within 6 months prior to the first dose.
- Clinically uncontrolled hypertension.
- Any factors increasing the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, use of any concomitant medications known or suspected to prolong the QT interval; Known history of allergy to any component of the study drug.
- 6. History of immunodeficiency disease, including other acquired or congenital immunodeficiency diseases, history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.
- 7. HIV infection, active HBV or HCV infection. The following exceptions are allowed:
- Patients positive for hepatitis B surface antigen (HBsAg), with or without positive hepatitis B core antibody (anti-HBc), if HBV DNA < 1000 IU/mL or below the lower limit of detection at the research center, and per investigator assessment excluding active infection based on clinical treatment and presentation.
- Hepatitis C (HCV) antibody-positive patients who are HCV RNA-negative. 8. History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, or glomerulonephritis, except for autoimmune thyroid dysfunction treated with stable-dose hormone replacement therapy.
- 9. Patients with known idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, interstitial lung disease, severe radiation pneumonitis, or evidence of active pneumonia on screening chest CT scan.
- 10. Inability to cooperate with lumbar puncture. 11. Vaccination with any vaccine within 28 days prior to the first dose. 12. Pregnant or lactating female patients; female patients of childbearing potential with baseline pregnancy test positive; or patients unwilling to use effective contraception throughout the trial period.
- 13. Presence of any concomitant disease, per investigator judgment, that seriously endangers the patient's safety or affects the patient's ability to complete the study (including but not limited to severe hypertension that cannot be controlled by medication, severe diabetes, active infection, thyroid disease, etc.).
- 14. Any other circumstances where the researcher deems 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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Hongxia wang, PHD, 021-64175590, whx365@126.com
whx365@126.com
About this study
Official title: A Phase II Observational Clinical Study on the Relationship Between Cerebrospinal Fluid Drug Concentration of Trastuzumab Deruxtecan and Efficacy in Central Nervous System Metastatic Breast Cancer
Approximately 5-15% breast cancer patients develop brain metastases. Current local treatments (surgery/radiotherapy) are associated with significant complications, and systemic treatments have limited efficacy. Although new-generation ADC drugs, such as trastuzumab deruxtecan, have demonstrated breakthrough efficacy in patients with brain metastases, the mechanisms of action are not fully elucidated, moreover the current treatment regimens still have limitations for patients with HER2-low expressing, safer and more effective systemic treatment options are urgently needed to improve patient survival. BCBM-006 is an open-label, prospective, single-arm, single-center Phase II clinical study to evaluate the relationship between cerebrospinal fluid drug concentration and efficacy of trastuzumab deruxtecan in central nervous system metastatic breast cancer, and explore the incidence of leptomeningeal metastases diagnosed via lumbar puncture in patients with brain parenchymal metastases, facilitate early intervention to improve prognosis.
- Being tested
- No Interventions
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
no interventions
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 : Patients with recurrent metastatic breast cancer without central nervous system metastase | (Control Cohort, N=10) Receives: Other: No Interventions | |
| Cohort 2: Patients with breast cancer and central nervous system metastases | (Experimental Cohort, N=30-50) Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between cerebrospinal fluid trastuzumab deruxtecan concentration and intracranial objective response
Spearman correlation coefficient between cerebrospinal fluid trastuzumab deruxtecan concentration (ng/mL), measured by iquid chromatography-tandem mass spectrometry (LC-MS/MS), and intracranial objective response assessed according to RANO-BM criteria.
Measured: Cerebrospinal fluid samples will be collected at baseline, 6 hours after initiation of trastuzumab deruxtecan infusion, and at disease progression. Intracranial efficacy will be assessed up to 24 months.
Secondary outcomes (11)
Objective Response Rate (ORR)
Percentage of participants achieving complete response (CR) or partial response (PR) according to RECIST version 1.1.
Measured: Assessed up to 24 months.
Intracranial Objective Response Rate (CNS-ORR)
Percentage of participants achieving complete response (CR) or partial response (PR) in intracranial lesions according to RANO-BM criteria.
Measured: Assessed up to 24 months.
Clinical Benefit Rate (CBR)
Percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD) lasting at least 24 weeks according to RECIST version 1.1.
Measured: Assessed up to 24 months.
Intracranial Clinical Benefit Rate (CNS-CBR)
Percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD) lasting at least 24 weeks in intracranial lesions according to RANO-BM criteria.
Measured: Assessed up to 24 months.
Progression-Free Survival (PFS)
Time from the first dose of trastuzumab deruxtecan until disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: From first dose until disease progression or death from any cause, assessed up to 24 months.
Intracranial Progression-Free Survival (CNS-PFS)
Time from the first dose of trastuzumab deruxtecan until intracranial progression according to RANO-BM criteria or death from any cause, whichever occurs first.
Measured: From first dose until intracranial progression or death from any cause, assessed up to 24 months.
Overall Survival (OS)
Time from the first dose of trastuzumab deruxtecan until death from any cause.
Measured: From first dose until death from any cause, assessed up to 24 months.
Duration of Response (DoR)
Time from the first documented complete response (CR) or partial response (PR) until disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: From first documented response until disease progression or death from any cause, assessed up to 24 months.
Number of Participants with Adverse Events (AEs)
Number of participants experiencing adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: From first dose through 30 days after the last dose of trastuzumab deruxtecan, assessed up to 24 months.
Health-Related Quality of Life Assessed by EORTC QLQ-C30
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are transformed to a 0-100 scale according to the EORTC scoring manual. Higher functional scores indicate better functioning, whereas higher symptom scores indicate greater symptom burden.
Measured: Baseline, prior to each treatment cycle, and at disease progression, assessed up to 24 months.
Neurologic Assessment in Neuro-Oncology (NANO) Scale Score
Neurological function assessed using the Neurologic Assessment in Neuro-Oncology (NANO) scale. Higher scores indicate greater neurologic impairment.
Measured: Baseline, prior to each treatment cycle, and at disease progression, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start11 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System (CNS) MetastasesStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653893
- Sponsor's protocol ID
- BCBM-006
- Acronym
- BCBM006
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2025
- Last updated
- 17 Jun 2026
- 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Observational Clinical Study on the Relationship Between Cerebrospinal Fluid Drug Concentration of Trastuzumab Deruxtecan and Efficacy in Central Nervous System Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07653893
- Acronym / sponsor ID
- BCBM006 / BCBM-006
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Jun 2026 (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.
Approximately 5-15% breast cancer patients develop brain metastases. Current local treatments (surgery/radiotherapy) are associated with significant complications, and systemic treatments have limited efficacy. Although new-generation ADC drugs, such as trastuzumab deruxtecan, have demonstrated breakthrough efficacy in patients with brain metastases, the mechanisms of action are not fully elucidated, moreover the current treatment regimens still have limitations for patients with HER2-low expressing, safer and more effective systemic treatment options are urgently needed to improve patient survival. BCBM-006 is an open-label, prospective, single-arm, single-center Phase II clinical study to evaluate the relationship between cerebrospinal fluid drug concentration and efficacy of trastuzumab deruxtecan in central nervous system metastatic breast cancer, and explore the incidence of leptomeningeal metastases diagnosed via lumbar puncture in patients with brain parenchymal metastases, facilitate early intervention to improve prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 : Patients with recurrent metastatic breast cancer without central nervous system metastase | – | Other: No Interventions(Control Cohort, N=10) |
| Cohort 2: Patients with breast cancer and central nervous system metastases | – | Other: No Interventions(Experimental Cohort, N=30-50) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients with recurrent metastatic breast cancer, divided into a control cohort without central nervous system metastases (N=10) and an experimental cohort with central nervous system metastases (N=30-50). Ptients in China
Key inclusion criteria (16 listed)
- 1. ≥18 years（2007-06）, any gender. 2. ECOG Performance Status 0-2. 3. Evidence of local recurrence or metastatic breast cancer not amenable to curative surgery or radiotherapy, and planned for intravenous trastuzumab deruxtecan treatment.
- 4. Expected survival time ≥8 weeks. 5. Provision of sufficient fresh tissue specimen or ≥10 unstained slides of tumor sample (primary and/or metastatic site) for biomarker analysis prior to treatment (intracranial metastatic lesion specimens preferred).
- 6. Cohort 2 (Experimental Cohort): Presence of brain parenchymal metastases confirmed by contrast-enhanced brain MRI, with at least one measurable brain lesion not previously irradiated, evaluable per RECIST 1.1 criteria.
- 7. Patients receiving mannitol, steroids, or anticonvulsant therapy prior to the first dose are eligible if the drug doses are stable for at least one week without requiring an increase, and neurological symptoms are stable for ≥1 week.
Key exclusion criteria (18 listed)
- 1. Presence of uncontrolled third-space fluid accumulation (e.g., large pleural effusion or ascites) not manageable by drainage or other methods, deemed unsuitable for enrollment by the investigator.
- 2. Previous treatment with an anti-HER2 ADC drug carrying the same payload resulting in resistance. Patients who discontinued prior ADC therapy for other reasons, including but not limited to toxicity, are eligible.
- 3. Adverse reactions from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v5.0 (except for ≤ Grade 2 toxicities judged by the investigator as having no safety risk, such as alopecia or long-term toxicities from radiotherapy).
- 4. History of other malignancies within the past 5 years, excluding cured carcinoma in situ of the cervix, basocellular skin carcinomas, or cutaneous squamous cell carcinoma.
- 5. History of severe cardiovascular or cerebrovascular diseases, including but not limited to:
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 |
|---|---|---|
| No Interventionsno interventions | Other | Cohort 1 : Patients with recurrent metastatic breast cancer without central nervous system metastase, Cohort 2: Patients with breast cancer and central nervous system metastases |
Primary outcome
Correlation between cerebrospinal fluid trastuzumab deruxtecan concentration and intracranial objective response
Time frame: Cerebrospinal fluid samples will be collected at baseline, 6 hours after initiation of trastuzumab deruxtecan infusion, and at disease progression. Intracranial efficacy will be assessed up to 24 months.
Spearman correlation coefficient between cerebrospinal fluid trastuzumab deruxtecan concentration (ng/mL), measured by iquid chromatography-tandem mass spectrometry (LC-MS/MS), and intracranial objective response assessed according to RANO-BM criteria.
11 secondary outcomes
Objective Response Rate (ORR)
Time frame: Assessed up to 24 months.
Intracranial Objective Response Rate (CNS-ORR)
Time frame: Assessed up to 24 months.
Clinical Benefit Rate (CBR)
Time frame: Assessed up to 24 months.
Intracranial Clinical Benefit Rate (CNS-CBR)
Time frame: Assessed up to 24 months.
Progression-Free Survival (PFS)
Time frame: From first dose until disease progression or death from any cause, assessed up to 24 months.
Intracranial Progression-Free Survival (CNS-PFS)
Time frame: From first dose until intracranial progression or death from any cause, assessed up to 24 months.
Overall Survival (OS)
Time frame: From first dose until death from any cause, assessed up to 24 months.
Duration of Response (DoR)
Time frame: From first documented response until disease progression or death from any cause, assessed up to 24 months.
Number of Participants with Adverse Events (AEs)
Time frame: From first dose through 30 days after the last dose of trastuzumab deruxtecan, assessed up to 24 months.
Health-Related Quality of Life Assessed by EORTC QLQ-C30
Time frame: Baseline, prior to each treatment cycle, and at disease progression, assessed up to 24 months.
Neurologic Assessment in Neuro-Oncology (NANO) Scale Score
Time frame: Baseline, prior to each treatment cycle, and at disease progression, assessed up to 24 months.
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 17 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?
An observational study of Central Nervous System (CNS) Metastases and Breast Cancer, run by Fudan University 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 18 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 17 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between cerebrospinal fluid trastuzumab deruxtecan concentration and intracranial objective response (time frame: Cerebrospinal fluid samples will be collected at baseline, 6 hours after initiation of trastuzumab deruxtecan infusion, and at disease progression. Intracranial efficacy will be assessed up to 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 17 Jun 2026.