TNBCPhase 2NCT06210438
SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases
A Phase 2 study testing SHR-A1921 + Bevacizumab in people with TNBC and Brain Metastasis, run by Fudan University at 1 site in China.
Trial summary
This is a phaseⅡ, single-arm study evaluating the efficacy and safety of SHR-A1921 Combined with Bevacizumab in Triple-negative Breast Cancer with Brain Metastases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TNBC, Brain Metastasis
- What is being tested?
- SHR-A1921 + Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years old, both genders
- ECOG Performance Status of 0-2
- Pathological tests confirm HR-negative/HER2-negative breast cancer；there is evidence of local recurrence or metastasis；not suitable with curative surgery or radiation therapy；HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is \<10%；HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-)
- Must have life-expectancy of ≥ 3 months
- MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy；
- Intraventricular catheter shunting or mannitol、steroid hormone、anticonvulsant drug is allowed before enrollment, but the dose of drug should be stable for at least one week and the neurological symptoms are stable for ≥1 week
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- Adequate function of major organs meets the following requirements (1)Blood routine
- ANC≥1.5×109/L；
- PLT≥75×109/L；
- Hb≥90 g/L(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) (2)Coagulation
- INR≤1.5，APTT≤1.5×ULN (3)Blood biochemistry
- TBIL≤1.5 × ULN;
- ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN);
- Urea nitrogen ≤ 1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL / min (Cockcroft-Gault formula) (4)Cardiac ultrasound
- LVEF≥50%; (5)12-lead ECG:
- females QTcF interval \<470msec and males \<450ms;
- Willing to join the study, sign informed consent, have good compliance and cooperate with follow-up.
Who cannot join
- Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture
- Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);
- Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment
- Has received prior therapy with bevacizumab and TROP-2 ADC drugs
- Participation in any other clinical trials within 2 weeks of enrollment
- Concurrent use of any other Anti-cancer drugs
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- Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma
- History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study
- History of allergy or hypersensitivity to any of the study drugs or study drug components
- History of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation
- A clear history of neurological or mental disorders, including epilepsy or dementia
- Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation
- According to the investigator\'s judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs)
- Any condition which in the investigator\'s opinion makes the subjects unsuitable for the study participation
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Biyun Wang, +86-021-64175590, pro_wangbiyun@163.com
Biyun Wang
About this study
Official title: SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases：a Prospective, Single-arm, Single-center Phase II Clinical Study
This is a phaseⅡ, single-arm study evaluating the efficacy and safety of SHR-A1921 Combined with Bevacizumab in Triple-negative Breast Cancer with Brain Metastases
- Conditions
- TNBC, Brain Metastasis
- Being tested
- SHR-A1921 + Bevacizumab
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1921 + BevacizumabDrug
SHR-A1921 + Bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1921 + Bevacizumab | Experimental | Not described Receives: Drug: SHR-A1921 + Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNS ORR
The proportion of patients who have a CR or PR in the CNS, as determined by the Investigator according to RANO-BM criteria
Measured: from enrollment to progression or death (for any reason), assessed up to 24 months
Secondary outcomes (5)
CNS CBR
CNS clinical benefit rate (CBR) will be defined as the percentage of patients who experience a CR, PR or Stable Disease (SD) for at least 24 weeks.
Measured: from enrollment to progression or death (for any reason), assessed up to 24 months
Progression-free survival
PFS will be defined as the time from the first dose of treatment to death or disease progression
Measured: Up to 2 years
Overall survival
OS will be defined as the time from the first dose of treatment to death for any cause
Measured: Up to 2 years
First progression site
The first lesion to progress
Measured: Up to 2 years
Safety as assessed by percentage of patients with any Adverse Event
Adverse event according to NCI-CTC AE 5.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBCStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
- Investigators
- Biyun wang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210438
- Sponsor's protocol ID
- BCBM-003
- Status last verified
- Dec 2023
- First submitted
- 4 Jan 2024
- Last updated
- 18 Jan 2024
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases：a Prospective, Single-arm, Single-center Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06210438
- Acronym / sponsor ID
- BCBM-003
- Conditions
- TNBC, Brain Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Jan 2024 (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.
This is a phaseⅡ, single-arm study evaluating the efficacy and safety of SHR-A1921 Combined with Bevacizumab in Triple-negative Breast Cancer with Brain Metastases
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1921 + Bevacizumab | Experimental | Drug: SHR-A1921 + Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years old, both genders
- ECOG Performance Status of 0-2
- Pathological tests confirm HR-negative/HER2-negative breast cancer；there is evidence of local recurrence or metastasis；not suitable with curative surgery or radiation therapy；HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is \<10%；HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-)
- Must have life-expectancy of ≥ 3 months
- MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy；
Key exclusion criteria (14 listed)
- Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture
- Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);
- Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment
- Has received prior therapy with bevacizumab and TROP-2 ADC drugs
- Participation in any other clinical trials within 2 weeks of enrollment
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 |
|---|---|---|
| SHR-A1921 + BevacizumabSHR-A1921 + Bevacizumab | Drug | SHR-A1921 + Bevacizumab |
Primary outcome
CNS ORR
Time frame: from enrollment to progression or death (for any reason), assessed up to 24 months
The proportion of patients who have a CR or PR in the CNS, as determined by the Investigator according to RANO-BM criteria
5 secondary outcomes
CNS CBR
Time frame: from enrollment to progression or death (for any reason), assessed up to 24 months
Progression-free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
First progression site
Time frame: Up to 2 years
Safety as assessed by percentage of patients with any Adverse Event
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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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. This study is not recruiting at the moment.
Biyun wang principal investigator
Fudan University
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 SHR-A1921 + Bevacizumab in people with TNBC and Brain Metastasis, 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 17 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biyun Wang (18017312387, pro_wangbiyun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS ORR (time frame: from enrollment to progression or death (for any reason), 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 18 Jan 2024.