Breast CancerPhase 2NCT06411457
SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
A Phase 2 study testing SHR-A1811+Adebrelimab in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To evaluate the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SHR-A1811+Adebrelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2024to 1 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years; ER/PgR expression ≤10% and low HER2 expression (IHC 1+, or IHC 2+ and ISH-); Advanced breast cancer patients; Prior treatment with ≥1 line of therapy for localized recurrence or metastatic disease; At least one prior treatment with taxane or anthracycline therapy; Allowed to receive immunotherapy during neoadjuvant or adjuvant stages; Measurable lesions according to RECIST 1.1 standards; ECOG PS score: 0-1; Voluntary participation with good compliance; Negative pregnancy test result, childbearing-age participants commit to effective contraception from the study start to 6 months after the last dose; Adequate organ function; Blood routine: ANC ≥1.5×109/L, PLT≥70×109/L, HGB ≥90g/L; Liver function: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum albumin ≥28 g/L, ALP ≤5×ULN; Stable liver function for at least 1 week after routine liver protection treatment, as assessed by the investigator, is eligible for inclusion; Renal function: Cr ≤1.5×ULN, or CrCl ≥50 mL/min (using standard Cockcroft-Gault formula); Coagulation function: INR ≤1.5/PT ≤1.5×ULN, aPTT ≤1.5×ULN; Left ventricular ejection fraction ≥50%
Who cannot join
- Active central nervous system metastases or carcinomatous meningitis (stable brain metastasis patients are allowed to participate); Prior treatment with anti-HER2 ADC drugs; Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; Childhood asthma completely resolved in adulthood without any intervention can be included, but asthma requiring bronchodilators for medical intervention in adulthood cannot be included); Patients using immunosuppressants or systemic steroid therapy for immunosuppressive purposes (dose>10mg/day prednisone or equivalent) in the 2 weeks before inclusion; Patients with other malignant tumors in the past or simultaneously; Grade ≥4 adverse reactions after ADC drug treatment, grade ≥3 immune-related adverse reactions; Known allergy to drug components used; Patients with known interstitial pneumonia; Poorly controlled clinical heart symptoms or diseases, such as: (1) NYHA class 2 or above heart failure; (2) unstable angina; (3) myocardial infarction within the past year; (4) patients with clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention; Active infection or unexplained fever >38.5°C during the screening period or before the first dose of study medication, depending on the investigator's judgment, patients with fever due to tumor can be included; Not receiving live vaccines within less than 4 weeks before or during the study; Patients known to have a history of psychiatric drug abuse, alcoholism, or drug addiction; Factors that may lead to the premature termination of the study judged by the investigator, such as other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, family or social factors affecting patient safety, data and sample collection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, 00
Qiao Li, Dr., +8615910573527, liqiaopumc@qq.com
Yue Chai, Dr., 13350804092, cy972628990@163.com
About this study
Official title: Single-arm, Multi-center Phase II Clinical Study of SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
To evaluate the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer
- Conditions
- Breast Cancer
- Being tested
- SHR-A1811+Adebrelimab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811+AdebrelimabDrug
Assess the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer SHR-A1811 : 6.4mg/kg , q3w，d1, ivgtt Adebrelimab : 1200mg, q3w，d1, ivgtt
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811+Adebrelimab | Experimental | Assess the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer Receives: Drug: SHR-A1811+Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Overall response rate
Measured: ORR date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
Secondary outcomes (4)
3-month PFS
progression-free survival rate at 3 month
Measured: 3-month progression-free survival rate will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause which ever came first assessed up to 3 month.
PFS
Progression-free survival
Measured: progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
Clinical benefit rate (CBR)
Measured: CBR will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
Safety endpoints
including incidence of adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE)
Measured: Safety date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start16 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, QIAO LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Qiao Li, M.D., Principal investigator, National Cancer Center/Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411457
- Sponsor's protocol ID
- NCC4483
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Multi-center Phase II Clinical Study of SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06411457
- Acronym / sponsor ID
- NCC4483
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 16 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 13 May 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.
To evaluate the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811+Adebrelimab | Experimental | Drug: SHR-A1811+AdebrelimabAssess the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years; ER/PgR expression ≤10% and low HER2 expression (IHC 1+, or IHC 2+ and ISH-); Advanced breast cancer patients; Prior treatment with ≥1 line of therapy for localized recurrence or metastatic disease; At least one prior treatment with taxane or anthracycline therapy; Allowed to receive immunotherapy during neoadjuvant or adjuvant stages; Measurable lesions according to RECIST 1.1 standards; ECOG PS score: 0-1; Voluntary participation with good compliance; Negative pregnancy test result, childbearing-age participants commit to effective contraception from the study start to 6 months after the last dose; Adequate organ function; Blood routine: ANC ≥1.5×109/L, PLT≥70×109/L, HGB ≥90g/L; Liver function: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum albumin ≥28 g/L, ALP ≤5×ULN; Stable liver function for at least 1 week after routine liver protection treatment, as assessed by the investigator, is eligible for inclusion; Renal function: Cr ≤1.5×ULN, or CrCl ≥50 mL/min (using standard Cockcroft-Gault formula); Coagulation function: INR ≤1.5/PT ≤1.5×ULN, aPTT ≤1.5×ULN; Left ventricular ejection fraction ≥50%
Key exclusion criteria (1 listed)
- Active central nervous system metastases or carcinomatous meningitis (stable brain metastasis patients are allowed to participate); Prior treatment with anti-HER2 ADC drugs; Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; Childhood asthma completely resolved in adulthood without any intervention can be included, but asthma requiring bronchodilators for medical intervention in adulthood cannot be included); Patients using immunosuppressants or systemic steroid therapy for immunosuppressive purposes (dose>10mg/day prednisone or equivalent) in the 2 weeks before inclusion; Patients with other malignant tumors in the past or simultaneously; Grade ≥4 adverse reactions after ADC drug treatment, grade ≥3 immune-related adverse reactions; Known allergy to drug components used; Patients with known interstitial pneumonia; Poorly controlled clinical heart symptoms or diseases, such as: (1) NYHA class 2 or above heart failure; (2) unstable angina; (3) myocardial infarction within the past year; (4) patients with clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention; Active infection or unexplained fever >38.5°C during the screening period or before the first dose of study medication, depending on the investigator's judgment, patients with fever due to tumor can be included; Not receiving live vaccines within less than 4 weeks before or during the study; Patients known to have a history of psychiatric drug abuse, alcoholism, or drug addiction; Factors that may lead to the premature termination of the study judged by the investigator, such as other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, family or social factors affecting patient safety, data and sample collection
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-A1811+AdebrelimabAssess the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer SHR-A1811 : 6.4mg/kg , q3w，d1, ivgtt Adebrelimab : 1200mg, q3w，d1, ivgtt | Drug | SHR-A1811+Adebrelimab |
Primary outcome
ORR
Time frame: ORR date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
Overall response rate
4 secondary outcomes
3-month PFS
Time frame: 3-month progression-free survival rate will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause which ever came first assessed up to 3 month.
PFS
Time frame: progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
Clinical benefit rate (CBR)
Time frame: CBR will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
Safety endpoints
Time frame: Safety date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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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.
Qiao Li, M.D. principal investigator
National Cancer Center/Cancer Hospital
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-A1811+Adebrelimab in people with 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 1 inclusion and 1 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 17 May 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 Qiao Li, M.D. (18500027849, liqiaopumc@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: ORR date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 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 17 May 2024.