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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01978171
Other study ID # UMCNONCO201302
Secondary ID
Status Completed
Phase
First received October 31, 2013
Last updated April 11, 2018
Start date May 2014
Est. completion date January 15, 2018

Study information

Verified date September 2017
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators will determine which factors are predictive for the development and severity of everolimus-induced interstitial lung disease and will develop a prediction model based on these risk factors.


Description:

In this study the investigators will prospectively investigate pulmonary adverse events during treatment with everolimus. The investigators will distinguish the following everolimus-induced pulmonary adverse events: pulmonary infection, everolimus-induced airway disease and everolimus-induced interstitial lung disease (ILD). The investigators will investigate the predictive value of pneumoproteins, everolimus exposure, pulmonary function tests, four distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the development and severity of everolimus-induced ILD.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date January 15, 2018
Est. primary completion date January 15, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.

- Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer

- Postmenopausal women

- Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment

- Resistance to treatment with a non-steroidal aromatase inhibitor

- Serum platelets = 100x10E9/l

- Everolimus dose adjustment is recommended for patients with hepatic impairment (Child-Pugh A/B/C)

- Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100)

Exclusion Criteria:

- Patients with a HER2-overexpressing tumor

- Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).

- Patients with a known history of HIV seropositivity or hepatitis B or C

- Uncontrolled diabetes mellitus

- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)

- Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A

Study Design


Locations

Country Name City State
Netherlands Antonius Ziekenhuis Nieuwegein
Netherlands Radboud university medical center Nijmegen

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary predictive factors of everolimus-induced ILD Find the correlation between:
pneumoproteins
everolimus exposure
pulmonary function tests
four distinct radiological patterns of 1.0mm CT slices of the lungs
baseline patient characteristics
the development and grade of everolimus-induced skin toxicity and oral mucositis
and the development and grade of everolimus-induced ILD
six months
Secondary temporal relation pneumoproteins and ILD Analyze the temporal relationship between a decrease in pulmonary function or the occurrence of new radiological pulmonary abnormalities and an increase in the level of pneumoproteins six months
Secondary pathophysiology of everolimus-induced ILD Investigate which immunological changes (cytokines, T-cells, dendritic cells) are observed in peripheral blood, skin biopsies and bronchoalveolar lavage fluid of patients with everolimus-induced toxicity six months
Secondary relation ILD and exposure and outcome Define the correlation between everolimus-induced ILD on the one hand and everolimus exposure (as per AUC0-24h) on day 14) and outcome (time to progression, as determined by treating physician) on the other hand six months
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