Influence of obesity and old age on the concentration of everolimus in blood

Phase 1

• Conditions: breast cancer; MedDRA version: 16.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001731-40-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-15
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

- Adult women (= 18 years of age) 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
- Progression following a non-steroidal aromatase inhibitor
- Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment.
- Falling into one of the following categories:
o elderly patients (age = 70 years and BMI < 30 kg/m2); or
o obese patients (BMI = 30 kg/m2 and age < 70 years); or
o control patients (BMI < 30 kg/m2 and age < 70 years);
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5 x ULN
- Adequate renal function: calculated creatinine clearance (as estimated by GFR using the MDRD formula) is MDRD = 30ml/min/1.73m2
- Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100)
- Patient is willing and able to sign the Informed Consent Form prior to screening evaluations
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

- Patients aged = 70 years AND BMI = 30 kg/m2
- HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive)
- Previous treatment with exemestane or mTOR inhibitors. Except for the treatment with exemestane in the adjuvant setting
- Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin)
- Patients with a known history of HIV seropositivity
- Any severe and / or uncontrolled medical condition such as:
o Unstable angina pectoris, serious uncontrolled cardiac arrhythmia
o Patients with severe hepatic impairment (Child-Pugh A/B/C)
o Uncontrolled diabetes mellitus
o 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 who test positive for hepatitis B or C (Patients who test negative for HBV-DNA, HBsAg, and HBcAb but positive for HBsAb with prior history of vaccination against Hepatitis B will be eligible). Only patients at higher risk for hepatitis B or C have to be tested.
- Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A within the last 5 days prior to enrollment
- History of non-compliance to medical regimens or patients unwilling to or unable to comply with the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified