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Trial Title:
Different Targeted Antibody-drug Conjugates For HER2 Ultra-low or No Expression Advanced Breast Cancer（GALAXY）
NCT ID:
NCT05824325
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811
Description:
HER2 ADC
Arm group label:
Experimental: HER2 ADC
Intervention type:
Drug
Intervention name:
TROP2 ADC
Description:
TROP2 ADC
Arm group label:
Experimental: TROP2 ADC
Summary:
This is a phaseⅠb/Ⅱ, open-label, two-arm parallel study evaluating the efficacy and
safety of different targeted antibody-drug conjugates for HER2 ultra-low or no expression
advanced breast cancer
Criteria for eligibility:
Criteria:
Inclusion Criteria:
ECOG Performance Status of 0 or 1
Pathologically documented breast cancer that:
1. is advanced or metastatic
2. is histologically confirmed to be HER2 IHC 0 (ISH- or untested)
3. was never previously HER2-positive (IHC 3+ or ISH+) At least one measurable lesion
according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version
1.1.
Disease progression on at least 1 previous line of chemotherapy for recurrent/metastatic
breast cancer. Subjects with HER2-negative and hormone-receptor positive tumors must have
progressed after at least 1 line of endocrine therapy with or without CDK4/6 inhibitor.
Has protocol-defined adequate organ and bone marrow function. Ability to understand and
willingness to sign a written informed consent document.
Exclusion Criteria:
Has previously been treated with any anti-HER2 therapy. Known prior severe
hypersensitivity to investigational product or any component in its formulation and other
monoclonal antibodies.
Any major surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted
therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine
therapy within 2 weeks before the first study drug administration.
History of other malignancy than breast cancer within 5 years prior to screening (except
for cured skin basal cell carcinoma and cervical carcinoma in situ).
Meningeal metastasis or active brain parenchymal metastasis. Any concurrent use of
immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression
purpose (dose of > 10mg/day prednisone or equivalent), and still in use within 2 weeks
before the first study drug administration.
Has uncontrolled intercurrent illness or significant cardiovascular disease. History of
clinically significant lung diseases. History of immunodeficiency, including HIV
positive. Known active hepatitis B virus or hepatitis C virus infection. Has any medical
history or condition that per protocol or in the opinion of the investigator is
inappropriate for the study.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Start date:
March 14, 2023
Completion date:
October 10, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05824325
