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Recruiting Phase 3 NCT05954442

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

Trial Parameters

Condition Triple Negative Breast Cancer
Sponsor Fudan University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 203
Sex FEMALE
Min Age 18 Years
Max Age 70 Years
Start Date 2023-09-13
Completion 2025-08
Interventions
EverolimusInvestigator's Choice of Chemotherapy

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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; * Pathologically confirmed breast cancer is triple negative breast cancer (IHC ER \< 1%, PR\<1%, HER2 0 OR +, if HER2++, FISH negative), and LAR subtype with mutation in PAM pathway; * Recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible;. * No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer; * Patients with at least one lesion (measurable and/or unmeasurable) that has not previously received radiation therapy can be accurately evaluated by CT/MRI at baseline and can be evaluated repeatedly according to RECIST 1.1; * The functions of the main organs are basically normal, and the following conditions a

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