Untreated Early-stage or Locally Advanced Breast CancerPhase 2NCT06592625
Neoadjuvant SHR-A1811 Plus Adebrelimab in HR Negative/Low & HER2 Low Breast Cancer Patients
A Phase 2 study testing SHR-A1811 and Adebrelimab in people with Untreated Early-stage or Locally Advanced Breast Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of the combination of SHR-A1811 with Adebrelimab Injection in treatment-naive patients with early-stage or locally advanced HR-negative or low expression, HER2 low expression breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Untreated Early-stage or Locally Advanced Breast Cancer
- What is being tested?
- SHR-A1811 and Adebrelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 28 Feb 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female treatment-naïve patients aged ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Breast cancer meeting the following criteria:
- Histologically confirmed invasive breast cancer with at least one tumor lesion >2 cm in diameter.
- Clinical stage II or III.
- Histologically or cytologically confirmed HR-negative or low expression and HER2 low expression breast cancer.
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- Adequate major organ function.
- Females of childbearing potential must agree to use highly effective contraception methods and avoid egg donation, and must have a negative serum pregnancy test within 7 days prior to the first treatment and during the study period. They must not be breastfeeding.
- Voluntarily agrees to participate in the clinical study and signs the informed consent form.
Who cannot join
- Tumor-related medical history and treatment history:
- Bilateral breast cancer (including contralateral carcinoma in situ).
- Stage IV (metastatic) breast cancer.
- Inflammatory breast cancer.
- Diagnosis of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) within 5 years.
- History of invasive breast cancer or metastatic breast cancer.
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- Prior surgical resection of the breast primary lesion or axillary lymph nodes before signing the informed consent.
- Diagnosis of any malignancy within 5 years before signing the informed consent, excluding adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cellcancer.
- Previous systemic targeted therapy, endocrine therapy, radiotherapy, or immunotherapy for any malignancy.
- Any of the following comorbidities/ medical history or treatment history:
- Known or suspected interstitial pneumonia; moderate to severe pulmonary disease significantly affecting respiratory function within three months before the first dose that could interfere with the detection or management of drug-related pulmonary toxicity; any pulmonary involvement from autoimmune, connective tissue, or inflammatory diseases, or previous total lung resection.
- Severe cardiovascular disease.
- Investigator determines any of the following:
- QT interval corrected by Fridericia's formula (QTcF) > 470 msec during screening.
- History of prolonged QT interval.
- Congenital long QT syndrome or family history of long QT syndrome.
- Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS), active tuberculosis, active hepatitis B, hepatitis C, or concurrent hepatitis B and C infections.
- Vascular thrombotic event within 3 months before randomization, such as deep vein thrombosis or pulmonary embolism.
- Severe infection within 4 weeks before randomization, or fever > 38.5°C of unknown cause during screening or before the first dose.
- Clinically significant bleeding symptoms or a known tendency to bleed within 1 month before signing the informed consent; known genetic or acquired bleeding or thrombotic tendencies.
- Abnormal coagulation function, bleeding tendency, or ongoing anticoagulant therapy with thrombolytics or long-term anticoagulation with warfarin or heparin, or long-term antiplatelet therapy.
- Other conditions that make the patient unsuitable for the study, such as severe systemic disease, kidney transplant, active bleeding disorders, or serious chronic gastrointestinal diseases related to diarrhea.
- Meets any of the following criteria related to study treatment:
- Systemic immunostimulatory agent treatment within 4 weeks before the first dose.
- Systemic immunosuppressive agent treatment within 4 weeks before the first dose. Excludes intranasal and inhaled corticosteroids or physiological doses of systemic steroids.
- Known allergy to the investigational product or any of its excipients.
- Participation in other anticancer therapy clinical trials concurrently.
- Received live attenuated vaccines within 30 days before the first dose of the study intervention.
- Previous or planned allogeneic bone marrow transplantation or solid organ transplantation.
- Women who have given birth within 1 year or are currently breastfeeding.
- Known history of substance abuse, alcoholism, or drug addiction.
- Other serious physical or mental illnesses or abnormal laboratory test results that may increase the risk of participating in the study or interfere with the study results, as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Shu Wang
About this study
Official title: A Multicenter, Single-arm, Phase 2 Study of Neoadjuvant SHR-A1811 Plus Adebrelimab Injection for Early-stage or Locally Advanced HR Negative or Low Expression/HER2 Low Expression Breast Cancer
The study is being conducted to evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of the combination of SHR-A1811 with Adebrelimab Injection in treatment-naive patients with early-stage or locally advanced HR-negative or low expression, HER2 low expression breast cancer.
- Being tested
- SHR-A1811, Adebrelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811
AdebrelimabDrug
Adebrelimab
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 plus Adebrelimab | Experimental | Not described Receives: Drug: SHR-A1811; Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed tpCR
Measured: Approximately 18 weeks after the first dose (after breast cancer surgery
Secondary outcomes (3)
Objective Response Rate (ORR)
Measured: Approximately 18 weeks after the first dose (before breast cancer surgery)
Change in Ki-67 index
Measured: Approximately 18 weeks after the first dose (after breast cancer surgery)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Measured: From signing the informed consent form to 40 days after the last dose of SHR-A1811, or 90 days after the last dose of Adebrelimab Injection (whichever is later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Untreated Early-stage or Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592625
- Sponsor's protocol ID
- SHR-A1811-213
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Phase 2 Study of Neoadjuvant SHR-A1811 Plus Adebrelimab Injection for Early-stage or Locally Advanced HR Negative or Low Expression/HER2 Low Expression Breast Cancer
- ClinicalTrials.gov ID
- NCT06592625
- Acronym / sponsor ID
- SHR-A1811-213
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 19 Sep 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.
The study is being conducted to evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of the combination of SHR-A1811 with Adebrelimab Injection in treatment-naive patients with early-stage or locally advanced HR-negative or low expression, HER2 low expression 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 plus Adebrelimab | Experimental | Drug: SHR-A1811, Drug: Adebrelimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female treatment-naïve patients aged ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Breast cancer meeting the following criteria:
- Adequate major organ function.
- Females of childbearing potential must agree to use highly effective contraception methods and avoid egg donation, and must have a negative serum pregnancy test within 7 days prior to the first treatment and during the study period. They must not be breastfeeding.
Key exclusion criteria (32 listed)
- Tumor-related medical history and treatment history:
- Any of the following comorbidities/ medical history or treatment history:
- Meets any of the following criteria related to study treatment:
- Participation in other anticancer therapy clinical trials concurrently.
- Received live attenuated vaccines within 30 days before the first dose of the study intervention.
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 | Drug | SHR-A1811 plus Adebrelimab |
| AdebrelimabAdebrelimab | Drug | SHR-A1811 plus Adebrelimab |
Primary outcome
Investigator-assessed tpCR
Time frame: Approximately 18 weeks after the first dose (after breast cancer surgery
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Approximately 18 weeks after the first dose (before breast cancer surgery)
Change in Ki-67 index
Time frame: Approximately 18 weeks after the first dose (after breast cancer surgery)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Time frame: From signing the informed consent form to 40 days after the last dose of SHR-A1811, or 90 days after the last dose of Adebrelimab Injection (whichever is later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 and Adebrelimab in people with Untreated Early-stage or Locally Advanced Breast Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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 9 inclusion and 32 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 19 Sep 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 Yuanyuan Wei (+0518-81220121, yuanyuan.wei.yw11@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed tpCR (time frame: Approximately 18 weeks after the first dose (after breast cancer surgery). 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 19 Sep 2024.