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.
This is a Phase II, open-label, Single-center platform study,Based on FUSCC four TNBC subtypes and the results of the previous FUTURE trial, the investigators designed this platform trial, which for combined the TNBC subtyping and genomic sequencing-guided precision targeted therapy for refractory metastatic TNBC patients. In this trial, refractory mTNBC patients eligible for inclusion can be divided into various precision treatment group according to molecular typing and subtyping to evaluate the efficacy and safety of multiple precision targeted treatment. The research therapy arm can be updated with the update of basic translational research in our center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
A1: an anti-HER2 antibody-drug conjugate (ADC)
A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC) Camrelizumab: an anti-programmed death-1 (PD-1) antibody
B1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGOverall response rate (ORR)
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: 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)
Progression Free Survival (PFS)
Time to progressive disease (according to RECIST1.1)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Up to One Year during follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC Camrelizumab: an anti-programmed death-1 (PD-1) antibody
C1: an anti-HER2 antibody-drug conjugate (ADC)
C2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC) BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
D1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
D2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
E1: an anti-HER2 antibody-drug conjugate (ADC)
F1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
G1: an anti-HER2 antibody-drug conjugate (ADC)
H1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
E1: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) everolimus: an mTOR inhibitor
TQB2102: an anti-HER2 antibody-drug conjugate (ADC) TQB2868: an anti-PD-1/TGF-β bispecific antibody in all-comer TNBC