NCT05954442

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

An Open, Randomized Phase III Study of Everolimus With Investigator's Choice of Chemotherapy Versus Chemotherapy in The First-Line Treatment of Luminal Androgen Receptor (LAR) Subtype With PI3K/AKT/mTOR Pathway Mutation of Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer (BCTOP-T-M03)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible participants will be those diagnosed with estrogen receptor (ER)-negative \[Immunohistochemistry (IHC) ER positive \<1% ) , progesterone receptor (PR) negative(IHC PR positive \<1% ) , and human epidermal growth factor receptor 2 (HER2)-negative \[IHC 0 or +; or IHC ++, Fluorescence in situ hybridization (FISH) -\], LAR subtype with PAM pathway mutation locally recurrent inoperable or metastatic breast cancer, who have received no prior chemotherapy, targeted therapy or other treatments. The study is aimed to evaluate the efficacy of investigator's choice (ICC) of chemotherapy (nab-paclitaxel, capecitabine, eribulin, carboplatin, vinorelbine, or utidelone) either alone or in combination with everolimus. This study aims to see if everolimus plus chemotherapy allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving investigator's choice of chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Conditions

• Triple Negative Breast Cancer
• Metastatic Breast Cancer
• Mutation

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus is a kind of mTOR inhibitors which has been approved to use in several kinds of cancers, especially in metastatic breast cancer .
DRUG	Investigator's Choice of Chemotherapy	Investigator'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.

Timeline

• Start date: 2023-09-13
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2023-07-20
• Last updated: 2024-01-16

Locations

1 site across 1 country: China