Breast Neoplasms Clinical Trial
— PREVENTOfficial title:
Prediction of Everolimus-induced Interstitial Lung Disease in Breast Cancer Patients; Maximizing Efficacy by Reducing Toxicity
Verified date | September 2017 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Antonius Ziekenhuis | Nieuwegein | |
Netherlands | Radboud university medical center | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
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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