prediction of lung problems as a side effect of treatment with everolimus for patients with breast cancer

Phase 1

• Conditions: breast cancer; MedDRA version: 20.0 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002258-60-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-15
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

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. Postmenopausal status is defined either by:
oAge = 55 years and one year or more of amenorrhea
oAge < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml
oSurgical menopause with bilateral oophorectomy
- Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment.
- Progression following a non-steroidal aromatase inhibitor
- 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 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

- 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 conditions such as:
oUnstable angina pectoris, serious uncontrolled cardiac arrhythmia
oPatients with severe hepatic impairment (Child-Pugh A/B/C)
oUncontrolled diabetes mellitus
oImpairment 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 will 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
- Patients unwilling to or unable to comply with the protocol

Study & Design

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