RecruitingPhase 3NCT05954442

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)


Sponsor

Fudan University

Enrollment

203 participants

Start Date

Sep 13, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing everolimus combined with a chemotherapy drug of the doctor's choice as a first treatment for a specific subtype of triple-negative breast cancer (TNBC) that is LAR (luminal androgen receptor) positive and has mutations in the PAM pathway. Triple-negative breast cancer does not respond to hormone therapy, and this subtype may respond to drugs that target different growth pathways. **You may be eligible if...** - You are 18 to 70 years old with confirmed triple-negative, LAR subtype breast cancer with PAM pathway mutations - Your cancer is recurrent or metastatic and cannot be fully removed with surgery - You have not previously received chemotherapy or targeted therapy for advanced disease - Your overall health (ECOG 0-1) and organ function are adequate - You have at least one measurable or evaluable lesion **You may NOT be eligible if...** - Your cancer has spread to the brain or you have a history of brain metastases - You have significant uncontrolled heart disease - You are pregnant or breastfeeding - You have active hepatitis B or C infection - You have had another cancer in the past 5 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEverolimus

Everolimus is a kind of mTOR inhibitors which has been approved to use in several kinds of cancers, especially in metastatic breast cancer .

DRUGInvestigator'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.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT05954442


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