NCT05054166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 2, 2021

Last Update Submit

September 13, 2021

Conditions

Breast CancerPI3K/AKT/mTOR Pathway MutationEverolimus

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

No intervention, it was a retrospective study.OTHER

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.

Eligibility Criteria

Age29 Years - 66 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HER2- metastatic breast cancer patients with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy.

You may qualify if:

  • Patients with HER2- metastatic breast cancer
  • Patients with PI3K/AKT/mTOR mutation

You may not qualify if:

  • Patients treated with endocrinotherapy and everolimus.
  • The efficacy evaluation could not be available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Xiao-jia Wang, Dr

    Zhejiang Cancer Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 23, 2021

Study Start

May 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 30, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

CN(1)