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OncoMatch/Clinical Trials/NCT05954442

Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype

Is NCT05954442 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Everolimus and Investigator's Choice of Chemotherapy for triple negative breast cancer.

Phase 3RecruitingFudan UniversityNCT05954442Data as of May 2026

Treatment: Everolimus · Investigator's Choice of ChemotherapyThe 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.

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer

Cannot have received: targeted therapy

No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer

Cannot have received: radiotherapy

Exception: within 3 weeks prior to study initiation

Patients have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks prior to study initiation

Cannot have received: endocrine therapy

Exception: within 3 weeks prior to study initiation

Patients have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks prior to study initiation

Cannot have received: molecular targeted therapy

Exception: within 3 weeks prior to study initiation

Patients have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks prior to study initiation

Cannot have received: surgery

Exception: within 3 weeks prior to study initiation

Patients have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks prior to study initiation

Lab requirements

Blood counts

HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×10^9/L; PLT≥75×10^9/L

Kidney function

Serum Cr ≤1×ULN, endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula)

Liver function

TBIL≤1.5× ULN; ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN

The functions of the main organs are basically normal, and the following conditions are met: Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L; PLT≥75×109/L; Biochemical examination shall meet the following standards: TBIL≤1.5× ULN; ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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