Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT01948960
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
* Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment.
* Progression following a non-steroidal aromatase inhibitor
* Falling into one of the following categories
* elderly patients (age ≥ 70 years and BMI \< 30 kg/m2); or
* obese patients (BMI ≥ 30 kg/m2 and age \< 70 years); or
* 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 ≥ 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
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 conditions such as:
* Unstable angina pectoris, serious uncontrolled cardiac arrhythmia
* Patients with severe hepatic impairment (Child-Pugh A/B/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 who test positive for hepatitis B or C
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01948960
Study Brief:
Protocol Section:
NCT01948960