Prediction of Everolimus-induced Interstitial Lung Disease

NCT01978171 | Completed

• 1 other identifier: UMCNONCO201302
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Neoplasms

Keywords

breast neoplasms; everolimus; interstitial lung disease; pneumonitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• temporal relation pneumoproteins and ILD

  six months

• pathophysiology of everolimus-induced ILD

  six months

• relation ILD and exposure and outcome

  six months

Study Arms (1)

breast cancer patients

Postmenopausal women with estrogen receptor (ER) positive advanced breast cancer whose disease is refractory to non steroidal aromatase inhibitors, and are eligible for treatment with exemestane and everolimus.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women with estrogen receptor (ER) positive advanced breast cancer whose disease is refractory to non steroidal aromatase inhibitors, and are eligible for treatment with exemestane and everolimus.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Radboud university medical center

Nijmegen, Netherlands

Location

Related Publications (1)

• Willemsen AECAB, Tol J, van Erp NP, Jonker MA, de Boer M, Meek B, de Jong PC, van Moorsel C, Gerritsen WR, Grutters JC, van Herpen CML. Prospective Study of Drug-induced Interstitial Lung Disease in Advanced Breast Cancer Patients Receiving Everolimus Plus Exemestane. Target Oncol. 2019 Aug;14(4):441-451. doi: 10.1007/s11523-019-00656-2.

  PMID: 31325105 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, skin biopsies, broncho-alveolar lavage fluid

MeSH Terms

Conditions

Breast Neoplasms; Lung Diseases, Interstitial; Pneumonia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections

Study Officials

• Carla van Herpen, MD, PhD

  Radboud university medical center, department of medical oncology

  PRINCIPAL INVESTIGATOR

• Nielka van Erp, PharmD, PhD

  Radboud university medical center, department of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: May 1, 2014
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: April 12, 2018

Record last verified: 2017-09

Locations

NL (2)