Trial Radar AI | ||
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Clinical Trial NCT05749588 for Triple-negative Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Fudan UniversityFUSCC Refractory TNBC Platform Study (FUTURE2.0) Phase 2 120 Open-Label
Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping（(A Phase II, Open-label, Single-center Platform Study）
- SCHBCC-N044
Molecular Subtype
Precision Treatment
Platform Study
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalIM/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 |
ExperimentalIM/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 |
ExperimentalBLIS / 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) |
ExperimentalBLIS /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) |
ExperimentalLAR / 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) |
ExperimentalLAR /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 |
ExperimentalMES/ 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) |
ExperimentalMES /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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall response rate (ORR) | The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1) | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 3 years) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Progression Free Survival (PFS) | Time to progressive disease (according to RECIST1.1) | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 3 years) |
Duration of Response (DoR) | Duration of whose best outcome is complete remission or partial remission (according to RECIST1.1) | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study(approximately 3 years) |
Disease Control Rate (DCR) | The proportion of patients with the best overall response of CR, PR, or stable disease (SD) | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study(approximately 3 years) |
Overall Survival (OS) | Time to death due to any cause | Randomization to death from any cause, through the end of study (approximately 3 years) |
CTCAE scale (V5.0) | To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V5.0) | Up to One Year during follow-up |
Female aged ≥18 years;
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;
Progression after at least one prior therapeutic regimens for advanced/metastatic TNBC
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);
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);
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;
ECOG score ≤1, and life expectancy ≥3 months;
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;
Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.
- Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);
- Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
- 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;
- 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;
- Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
- Pregnant or lactating patients;
- Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.
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