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NCT05054166 Clinical Trial

Efficacy of Everolimus-containing Chemotherapy in HER2- mBC Patients With PI3K/AKT/mTOR Mutations Study

Breast Cancer Clinical Trial

Official title:
Efficacy of Everolimus-containing Chemotherapy in HER2 Negative Metastatic Breast Cancer Patients With PI3K/AKT/mTOR Mutations: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05054166
Other study ID # EVE-CWM-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date August 30, 2021

Study information
Verified date September 2021
Source Zhejiang Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.14 cases of HER2- metastatic breast cancer patients with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was studied.

Description:

The PI3K/AKT/mTOR pathway is frequently altered in breast cancer. Everolimus is a selective inhibitor of mammalian target of Rapamycin (mTOR).The benefit of everolimus in metastatic breast cancer patients with PI3K/AKT/mTOR mutations remains unclear, especially in TNBC patients. The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations. 14 cases of HER2- metastatic breast cancer participants with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was studied.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date August 30, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 29 Years to 66 Years
Eligibility Inclusion Criteria: 1. Patients with HER2- metastatic breast cancer 2. Patients with PI3K/AKT/mTOR mutation Exclusion Criteria: 1. Patients treated with endocrinotherapy and everolimus. 2. The efficacy evaluation could not be available.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention, it was a retrospective study.
This study aimed to retrospectively investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.There was no intervention.

Locations
Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS Progression free survival The PFS was defined as the interval from the date of taking the everolimus-containing chemotherapy to the date of the first occurrence of disease progression or death from any cause,whichever came first, assessed up to 24 months.
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