NL-OMON38713
Completed
Phase 4
Influence of exceptional patient characteristics on everolimus exposure - INPRES
niversitair Medisch Centrum Sint Radboud0 sites75 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Breast cancer
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 75
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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);
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
Outcomes
Primary Outcomes
Not specified
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