Breasr CancerPhase 2NCT06361979
SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases
A Phase 2 study testing SHR-A1811 and Bevacizumab in people with Breasr Cancer, run by Huihua Xiong.
Trial summary
This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breasr Cancer
- What is being tested?
- SHR-A1811 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old;
- Pathologically confirmed HER2-positive breast cancer;
- At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
- More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed.
- Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
- Adequate function of major organs-
Who cannot join
- Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
- Previous treatment with bevacizumab;
- Participated in other drug clinical trials within 4 weeks before admission;
- History of clinically significant lung disease；
- Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
- According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
- Any other conditions that researchers believe that patients are unsuitable for this study.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-arm, Exploratory Clinical Study of SHR-A1811 Combined With Bevacizumab in the Treatment of HER2-positive Breast Cancer With Brain Metastases
This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases
- Conditions
- Breasr Cancer
- Being tested
- SHR-A1811, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811: intravenous
BevacizumabDrug
Bevacizumab:intravenous
| Study group | Role | What they receive |
|---|---|---|
| ARM1 | Experimental | Not described Receives: Drug: SHR-A1811; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNS-ORR
CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria
Measured: Up to 2 years
Secondary outcomes (3)
PFS
PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first
Measured: up to 2 years
ORR
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR assessed by the investigator according to RECIST version 1.1
Measured: Up to 2 years
AE
Proportion of participants experienced adverse events during the study period
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 posted12 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breasr 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huihua Xiong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huihua Xiong, Tongji Hospital
- Investigators
- Xiong huihua, Principal investigator, Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361979
- Sponsor's protocol ID
- A1811
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Exploratory Clinical Study of SHR-A1811 Combined With Bevacizumab in the Treatment of HER2-positive Breast Cancer With Brain Metastases
- ClinicalTrials.gov ID
- NCT06361979
- Acronym / sponsor ID
- A1811
- Conditions
- Breasr Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Huihua XiongUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Apr 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 study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive 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 |
|---|---|---|
| ARM1 | Experimental | Drug: SHR-A1811, Drug: Bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years old;
- Pathologically confirmed HER2-positive breast cancer;
- At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
- More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed.
- Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
Key exclusion criteria (8 listed)
- Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
- Previous treatment with bevacizumab;
- Participated in other drug clinical trials within 4 weeks before admission;
- History of clinically significant lung disease；
- Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
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-A1811SHR-A1811: intravenous | Drug | ARM1 |
| BevacizumabBevacizumab:intravenous | Drug | ARM1 |
Primary outcome
CNS-ORR
Time frame: Up to 2 years
CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria
3 secondary outcomes
PFS
Time frame: up to 2 years
ORR
Time frame: Up to 2 years
AE
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 12 Apr 2024.
- Individual participant dataSharing planned: Undecided
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.
Xiong huihua principal investigator
Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811 and Bevacizumab in people with Breasr Cancer, run by Huihua Xiong.
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 6 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiong huihua (13886073988, xionghuihua@hotmail.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: Up to 2 years). 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 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.