Everolimus Related Pneumonitis in MBC

Pneumonitis Clinical Trial

Official title:

Drug-related Pneumonitis During mTOR Inhibitor Therapy in Patients With Metastatic Breast Cancer: A Radiographic Patternbased Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730428
• Other study ID #: YOUNGBC-5
• Status: Completed
• Start date: July 15, 2017
• Est. completion date: June 15, 2020

Study information

• Verified date: August 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Postmenopausal woman (or premenopausal women treated with LHRHa) diagnosed with HR+,HER2- metastatic breast cancer

2. Treated with everolimus for at least one month in metastatic setting

3. With baseline and at least one follow-up chest CT during everolimus therapy.

4. Complete medical history

Exclusion Criteria:

1. Incomplete medical history

2. Radiographic imaging unavailable

Related Conditions & MeSH terms

• Everolimus
• Pneumonia
• Pneumonitis

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiographic pattern	Quantitive measure of lung CT	2 months
Primary	PFS	Progression free survival	2 months