The goal of this clinical trial is to evaluate the efficacy of investigator's choice of chemotherapy, either alone or in combination with everolimus, in treating patients with locally recurrent inoperable or metastatic triple-negative breast cancer, luminal androgen receptor (LAR) subtype with PI3K/AKT/mTOR (PAM) pathway mutation, as the first-line treatment.
Patients need to meet all of the following conditions
Patients must be ≥18 and ≤ 70 years of age;
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
The expected survival is more than 3 months;
Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastasis, enhanced CT or enhanced MRI must be performed within 28 days before the first dose to rule out central nervous system metastasis.
A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
Persistent grade ≥1 adverse events due to previous treatment. The exception to this is hair loss or something the researchers believe should not be ruled out. Such cases should be clearly documented in the investigator's notes;
Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access);
Parallel
Everolimus
DrugEverolimus is a kind of mTOR inhibitors which has been approved to use in several kinds of cancers, especially in metastatic breast cancer .
Investigator's Choice of Chemotherapy
DrugInvestigator's choice of chemotherapy means the chemotherapy chosen by investigators/doctors to treat metastatic triple negative breast cancer, including nab-paclitaxel, capecitabine, eribulin, carboplatin, vinorelbine, or utidelone.
Progression-free survival (PFS)
The interval from randomization until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.
Objective response rate (ORR)
The proportion of participants who have a complete response (CR) or partial response (PR) according to RECIST 1.1.
Duration of response (DoR)
The interval from date of first detection of objective response until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.
Disease control rate (DCR)
The proportion of participants with complete response, partial response, and stable disease for more than 4 weeks in which response can be evaluated.
Overall survival (OS)
The interval from randomization until the date of death due to any cause.
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