SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
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
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Qiao Li, M.D.
- Phone Number: 18500027849
- Email: liqiaopumc@qq.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 00
- Recruiting
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
-
Contact:
- Qiao Li, Dr.
- Phone Number: +8615910573527
- Email: liqiaopumc@qq.com
-
Contact:
- Yue Chai, Dr.
- Phone Number: 13350804092
- Email: cy972628990@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SHR-A1811+Adebrelimab
Assess the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
progression-free survival rate at 3 month
|
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
|
Progression-free survival
|
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
|
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
|
including incidence of adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE)
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Qiao Li, M.D., National Cancer Center/Cancer Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC4483
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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