NCT03730428

Brief Summary

To study the drug-related pneumonitis during mTOR inhibitor therapy in patients with metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Typical duration 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

July 15, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

November 2, 2018

Last Update Submit

August 16, 2020

Conditions

EverolimusPneumonitis

Outcome Measures

Primary Outcomes (2)

  • radiographic pattern

    Quantitive measure of lung CT

    2 months

  • PFS

    Progression free survival

    2 months

Study Arms (2)

pneumonitis group

Patients who developed drug-related pneumonitis after treated with everolims

non-pneumonitis group

Patients who didn't develop drug-related pneumonitis after treated with everolims

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

You may qualify if:

  • Postmenopausal woman (or premenopausal women treated with LHRHa) diagnosed with HR+，HER2- metastatic breast cancer
  • Treated with everolimus for at least one month in metastatic setting
  • With baseline and at least one follow-up chest CT during everolimus therapy.
  • Complete medical history

You may not qualify if:

  • Incomplete medical history
  • Radiographic imaging unavailable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Biyun Wang, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 5, 2018

Study Start

July 15, 2017

Primary Completion

May 15, 2020

Study Completion

June 15, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations

CN(1)