Breast CancerPhase 2NCT07047443
SHR-1811 Combined With Carboplatin in the Treatment of Advanced Breast Cancer With HER2 Expression
A Phase 2 study testing SHR- A1811 in people with Breast Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial summary
To find the optimal dose of carboplatin combined with SHR-A1811 in her2-expressed metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SHR- A1811
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Dec 2029
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 to 75 (inclusive of both values).
- Unresectable or metastatic breast cancer with HER2 positive (IHC 3+ or IHC 2+/ISH+), low HER2 expression (IHC 1+ or IHC 2+/ISH-), or ultra-low HER2 expression (IHC 0 with membrane staining) confirmed by histology or cytology.
- Failure of standard treatment in the advanced stage.
- For HER2+ metastatic breast cancer, one can have received second-generation ADC (such as T-DM1) treatment, but cannot have received third-generation ADC (such as T-DXd) treatment. For HER2 low expression or HER2 ultra-low expression metastatic breast cancer, it is necessary to meet the requirement that no ADC drug treatment has been received.
- For HER2-positive metastatic breast cancer, at the metastatic stage, ≥1 line of anti-HER2 treatment must have been received; For HR-positive metastatic breast cancer with low or ultra-low expression of HER2, it is necessary to meet the failure of CDK4/6 inhibitor treatment at the metastatic stage. For HR-negative metastatic breast cancer with low or ultra-low expression of HER2, it is necessary to have received ≥ first-line chemotherapy at the metastatic stage.
- The ECOG score is 0 or 1.
Show all 10Show fewer
- There is at least one lesion (including measurable or unmeasurable) according to the RECIST v1.1 standard.
- Adequate organ function.
- Participants with fertility or their spouses must agree to use appropriate contraceptive measures from the start of the first dose of the study treatment until 120 days after the last dose of the study treatment.
- Voluntarily join this study and sign the informed consent form.
Who cannot join
- Have had other malignant tumors within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- There is effusion in the third space that cannot be controlled by methods such as drainage (such as a large amount of ascites, pleural effusion, and pericardial effusion).
- Clinical researchers who have received surgical treatment (referring to major surgeries for cancer), radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drugs within 4 weeks before the first medication; Those who have received endocrine therapy within two weeks before the first medication.
- Patients with HER2+ metastatic breast cancer have received treatment with third-generation ADCs (such as T-DXd); Patients with HER2 low-expression or ultra-low-expression metastatic breast cancer who have received any ADC drug treatment.
- The patient has any active autoimmune diseases or a history of autoimmune diseases that may recur [including but not limited to: autoimmune hepatitis, uveitis, enteritis, pituitinitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects that can be controlled only through hormone replacement therapy can be included)]; Subjects with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes treated with insulin, or asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included. Asthma patients who require medical intervention with bronchodilators cannot be included.
- Have a history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
Show all 12Show fewer
- There are clinically significant cardiovascular diseases, such as severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA ≥ grade II), clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention, and myocardial infarction that occurred within 6 months before the first medication.
- Subjects with known or suspected interstitial pneumonia; There are other moderate to severe pulmonary diseases that may interfere with drug-related pulmonary toxicity testing or management and seriously affect respiratory function within three months before the first administration, including but not limited to idiopathic pulmonary fibrosis, organized pneumonia/oblusive bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive/restrictive lung disease, etc. And any autoimmune, connective tissue or inflammatory diseases involving the lungs, such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc., or those who have undergone total lung resection surgery in the past. Subjects who had experienced grade ≥3 interstitial pneumonia during previous treatment with immune checkpoint inhibitors were not allowed to be enrolled in this study.
- Known hereditary or acquired bleeding predisposition (such as hemophilia, coagulation dysfunction, etc.).
- There are active hepatitis B (HBsAg positive and HBV DNA≥500 IU/mL), hepatitis C (hepatitis C antibody positive and HCV RNA higher than the upper limit of the normal range), and liver cirrhosis; Or severely infected individuals who need to be controlled with antibiotics, antiviral drugs or antifungal drugs.
- According to the NCI-CTCAE v5.0 classification, those whose toxicity caused by previous anti-tumor treatment has not yet recovered to grade ≤ Ⅰ (except for alopecia; According to the judgment of the researchers, after consultation with the sponsor, some tolerable chronic grade II toxicities may be excluded.
- Known allergy to any of the investigational drugs or any of its excipients.
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
Anhui Cancer Hospital
Hefei, Anhui
Yang Zhou, +86 13802214658, yang.zhou.zy100@hengrui.com
About this study
Official title: Dose Exploration Study of SHR-1811 Combined With Carboplatin in the Treatment of Advanced Breast Cancer With HER2 Expression
To find the optimal dose of carboplatin combined with SHR-A1811 in her2-expressed metastatic breast cancer
- Conditions
- Breast Cancer
- Being tested
- SHR- A1811
- 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- A1811Drug
HER2 ADC
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 4.8mg/kg + Carboplatin | Experimental | This study adopts the dose escalation pattern of 3+3. Patients with advanced breast cancer expressing HER2 received SHR-A1811 + carboplatin treatment. The dose of SHR-A1811 was fixed at 4.8mg/kg, Q3W, and the initial dose of carboplatin was AUC 2, Q3W. The first cycle of medication (21 days) was used as the tolerance observation period.
If the subjects cannot tolerate the initial dose combination (intolerance refers to an incidence of DLT ≥33%), the study will be terminated. If it can be tolerated (tolerance refers to the incidence of DLT < 33%), the dose of carboplatin will be increased to AUC 3; If still tolerable, continue to increase the dose of carboplatin to AUC 4. Receives: Drug: SHR- A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (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.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue-Yin Pan, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047443
- Sponsor's protocol ID
- Anhui1811Carbo
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Exploration Study of SHR-1811 Combined With Carboplatin in the Treatment of Advanced Breast Cancer With HER2 Expression
- ClinicalTrials.gov ID
- NCT07047443
- Acronym / sponsor ID
- Anhui1811Carbo
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Jul 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.
To find the optimal dose of carboplatin combined with SHR-A1811 in her2-expressed metastatic breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 4.8mg/kg + Carboplatin | Experimental | Drug: SHR- A1811This study adopts the dose escalation pattern of 3+3. Patients with advanced breast cancer expressing HER2 received SHR-A1811 + carboplatin treatment. The dose of SHR-A1811 was fixed at 4.8mg/kg, Q3W, and the initial dose of carboplatin was AUC 2, Q3W. The first cycle of medication (21 days) was used as the tolerance observation period. If the subjects cannot tolerate the initial dose combination (intolerance refers to an incidence of DLT ≥33%), the study will be terminated. If it can be tolerated (tolerance refers to the incidence of DLT < 33%), the dose of carboplatin will be increased to AUC 3; If still tolerable, continue to increase the dose of carboplatin to AUC 4. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women aged 18 to 75 (inclusive of both values).
- Unresectable or metastatic breast cancer with HER2 positive (IHC 3+ or IHC 2+/ISH+), low HER2 expression (IHC 1+ or IHC 2+/ISH-), or ultra-low HER2 expression (IHC 0 with membrane staining) confirmed by histology or cytology.
- Failure of standard treatment in the advanced stage.
- For HER2+ metastatic breast cancer, one can have received second-generation ADC (such as T-DM1) treatment, but cannot have received third-generation ADC (such as T-DXd) treatment. For HER2 low expression or HER2 ultra-low expression metastatic breast cancer, it is necessary to meet the requirement that no ADC drug treatment has been received.
- For HER2-positive metastatic breast cancer, at the metastatic stage, ≥1 line of anti-HER2 treatment must have been received; For HR-positive metastatic breast cancer with low or ultra-low expression of HER2, it is necessary to meet the failure of CDK4/6 inhibitor treatment at the metastatic stage. For HR-negative metastatic breast cancer with low or ultra-low expression of HER2, it is necessary to have received ≥ first-line chemotherapy at the metastatic stage.
Key exclusion criteria (12 listed)
- Have had other malignant tumors within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- There is effusion in the third space that cannot be controlled by methods such as drainage (such as a large amount of ascites, pleural effusion, and pericardial effusion).
- Clinical researchers who have received surgical treatment (referring to major surgeries for cancer), radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drugs within 4 weeks before the first medication; Those who have received endocrine therapy within two weeks before the first medication.
- Patients with HER2+ metastatic breast cancer have received treatment with third-generation ADCs (such as T-DXd); Patients with HER2 low-expression or ultra-low-expression metastatic breast cancer who have received any ADC drug treatment.
- The patient has any active autoimmune diseases or a history of autoimmune diseases that may recur [including but not limited to: autoimmune hepatitis, uveitis, enteritis, pituitinitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects that can be controlled only through hormone replacement therapy can be included)]; Subjects with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes treated with insulin, or asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included. Asthma patients who require medical intervention with bronchodilators cannot be included.
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- A1811HER2 ADC | Drug | SHR-A1811 4.8mg/kg + Carboplatin |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 2 years
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 2 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 SHR- A1811 in people with Breast Cancer, run by Anhui Provincial Cancer Hospital 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 10 inclusion and 12 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: opening soon, as of the sponsor's last update on 2 Jul 2025. 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 Yan Luo (+86 13802214658, yan.luo.yl5@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 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 2 Jul 2025.