To hear about similar clinical trials, please enter your email below
Trial Title:
SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
NCT ID:
NCT06411457
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811+Adebrelimab
Description:
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
Arm group label:
SHR-A1811+Adebrelimab
Summary:
To evaluate the efficacy and safety of the SHR-A1811 in combination with Adebrelimab
regimen in HER2 low-expressing metastatic breast cancer
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Address:
City:
Beijing
Zip:
00
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiao Li, Dr.
Phone:
+8615910573527
Email:
liqiaopumc@qq.com
Contact backup:
Last name:
Yue Chai, Dr.
Phone:
13350804092
Email:
cy972628990@163.com
Start date:
May 16, 2024
Completion date:
May 1, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06411457
