This study is a prospective, single-center, open-label, umbrella-shaped phase II clinical study for patients with HR+/HER2- endocrine-resistant advanced breast cancer.
Seven precision treatment cohorts, which targeting NF1 mutation, gBRCA mutation,HER2 mutation, FDGFRb mutation PAM pathway mutations, CD8 and AR, as long as an epigenetic therapy cohort and a combined immunization cohort were initially set up based on gene expression profiles and molecular pathways. The main purpose is to screen valuable treatment cohorts and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
319
Cancer Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGORR
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 end of study (approximately 5 years)
CBR
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the evaluable subjects
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
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 end of study (approximately 5 years)
OS
time to death due to any cause
Time frame: Randomization to death from any cause, through the end of study (approximately 5 years)
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HER1 / HER2 receptor tyrosine kinase inhibitor
In Arm III, if the patient had not previously used capecitabine,she would receive pyrotinib and capecitabine, if the patients have previously used capecitabine, she would only used pyrotinib as a single agent.
PD-1 antibody
mTOR inhibitor
Albumin bound paclitaxel
EZH2 inhibitor
AR inhibitor
CDK4/6 inhibitor
anti-PD-L1/TGF-βRII bifunctional fusion protein
Fulvestrant
aromatase inhibitor
Bevacizumab