Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2023-03-30
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IM/HER2-low
If patients were triple-negative breast cancer with IM subtype and HER2-low-positive
A1: SHR-A1811
A1: an anti-HER2 antibody-drug conjugate (ADC)
A2: SHR-A1811 with Camrelizumab
A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)
Camrelizumab: an anti-programmed death-1 (PD-1) antibody
IM/HER2-0
If patients were triple-negative breast cancer with IM subtype and HER2-zero
B1: TROP2 ADC
B1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
B2: TROP2 ADC with Camrelizumab
B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC
Camrelizumab: an anti-programmed death-1 (PD-1) antibody
BLIS / HER2-low
If patients were triple-negative breast cancer with BLIS subtype and HER2-low-positive
C1: SHR-A1811
C1: an anti-HER2 antibody-drug conjugate (ADC)
C2: SHR-A1811 with BP102
C2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)
BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
BLIS /HER2-0
If patients were triple-negative breast cancer with BLIS subtype and HER2-zero
D1: TROP2 ADC
D1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
D2: TROP2 ADC with BP102
D2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC
BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
LAR / HER2-low
If patients were triple-negative breast cancer with LAR subtype and HER2-low-positive
E1: SHR-A1811
E1: an anti-HER2 antibody-drug conjugate (ADC)
LAR /HER2-0
If patients were triple-negative breast cancer with LAR subtype and HER2-zero
F1: TROP2 ADC
F1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
MES/ HER2-low
If patients were triple-negative breast cancer with MES subtype and HER2-low-positive
G1: SHR-A1811
G1: an anti-HER2 antibody-drug conjugate (ADC)
MES /HER2-0
If patients were triple-negative breast cancer with MES subtype and HER2-zero
H1: TROP2 ADC
H1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
Interventions
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A1: SHR-A1811
A1: an anti-HER2 antibody-drug conjugate (ADC)
A2: SHR-A1811 with Camrelizumab
A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)
Camrelizumab: an anti-programmed death-1 (PD-1) antibody
B1: TROP2 ADC
B1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
B2: TROP2 ADC with Camrelizumab
B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC
Camrelizumab: an anti-programmed death-1 (PD-1) antibody
C1: SHR-A1811
C1: an anti-HER2 antibody-drug conjugate (ADC)
C2: SHR-A1811 with BP102
C2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)
BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
D1: TROP2 ADC
D1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
D2: TROP2 ADC with BP102
D2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC
BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
E1: SHR-A1811
E1: an anti-HER2 antibody-drug conjugate (ADC)
F1: TROP2 ADC
F1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
G1: SHR-A1811
G1: an anti-HER2 antibody-drug conjugate (ADC)
H1: TROP2 ADC
H1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. TNBC invasive breast cancer confirmed by histology (specific definition: ER \<1% positive tumor cells by immunohistochemistry are defined as ER negative, PR \<1% positive tumor cells are defined as PR negative, HER2 0-1+ or HER2 ++ but negative by FISH without amplification was defined as HER2 negative); Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
3. Progression after at least one prior therapeutic regimens for advanced/metastatic TNBC
4. At least one measurable lesion according to RECIST 1.1 (conventional CT scan ≥20 mm, spiral CT scan ≥10 mm, measurable lesion has not received radiotherapy);
5. The functions of the main organs are basically normal and meet the following conditions:
i. Blood routine examination criteria shall meet: HB ≥90 g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 10\^9 /L; PLT acuity 75 x 10\^9 /L;
ii. Biochemical tests should meet the following criteria: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
6. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity;
7. ECOG score ≤1, and life expectancy ≥3 months;
8. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;
9. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.
Exclusion Criteria
2. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
3. A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;
4. Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;
5. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
6. Pregnant or lactating patients;
7. Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.
18 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
Professor
Principal Investigators
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Zhimin Shao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SCHBCC-N044
Identifier Type: -
Identifier Source: org_study_id
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