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

• Sponsor: Zhejiang Cancer Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05054166
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Actual Duration (Months): 4
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; PI3K/AKT/mTOR Pathway Mutation; Everolimus	Other: No intervention, it was a retrospective study.

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 14 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Efficacy of Everolimus-containing Chemotherapy in HER2 Negative Metastatic Breast Cancer Patients With PI3K/AKT/mTOR Mutations: A Retrospective Study
• Actual Study Start Date: May 1, 2021
• Actual Primary Completion Date: Aug 1, 2021
• Actual Study Completion Date: Aug 30, 2021

Outcome Measures

Primary Outcome Measures

1. PFS [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.]

   Progression free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 29 Years to 66 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China

Sponsors and Collaborators

• Zhejiang Cancer Hospital

Investigators

• Study Director: Xiao-jia Wang, Dr, Zhejiang Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wen-Ming Cao, Professor, Zhejiang Cancer Hospital
• ClinicalTrials.gov Identifier: NCT05054166
• Other Study ID Numbers: EVE-CWM-01
• First Posted: Sep 23, 2021
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 23, 2021