A1: SHR-A1811A2: SHR-A1811 with Camrelizumab with famitinibB1: TROP2 ADCB2: TROP2 ADC with CamrelizumabC1: SHR-A1811C2: SHR-A1811 with BP102D1: TROP2 ADCD2: TROP2 ADC with BP102E1: SHR-A1811F1: TROP2 ADCG1: SHR-A1811H1: TROP2 ADCE2: SHR-A1811 with everolimusTQB2102 with TQB2868
A1: SHR-A1811: A1: an anti-HER2 antibody-drug conjugate (ADC)
A2: SHR-A1811 with Camrelizumab with famitinib: A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)
Camrelizumab: an anti-programmed death-1 (PD-1) antibody
E2: SHR-A1811 with everolimus: E1: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) everolimus: an mTOR inhibitor
TQB2102 with TQB2868: TQB2102: an anti-HER2 antibody-drug conjugate (ADC) TQB2868: an anti-PD-1/TGF-β bispecific antibody in all-comer TNBC
Study summary
This is a Phase II, open-label, Single-center platform study research based on molecular subtypes to explore precision therapy in refractory triple-negative breast cancer.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Female aged ≥18 years;
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:
1. 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);
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.
Primary outcome measure(s)
Overall response rate (ORR) — 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) The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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