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:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT02313051
Eligibility Criteria:
Inclusion Criteria:
* Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative surgery.
* Histological confirmation of estrogen and/or progesterone-receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2 -) breast cancer.
ER/PR positive: nuclear reaction \> 1%, HER2 negative: HER2; IHC 0,1+ or FISH/CISH (-) in case of IHC 2+
* Patients who:
* received Tamoxifen for at least 6 months during adjuvant treatment and recurred during or within 24 months after the end of adjuvant treatment completion,
* progressed during tamoxifen treatment for advanced disease.
* Pre-menopausal status was defined as either :
* The patient has a history of regular menstrual periods within 12 weeks prior to study enrollment
* The patient has FSH and E2 levels with in pre-menopausal range based on local laboratory assessments measured (i.e, FSH ≤ 40 mIU/mL and E2 ≥10 pg/mL)within 12 weeks prior to study enrollment.
* ECOG performance status of 0,1, or 2
* At least one measurable lesion or mainly lytic bone lesions in the absence of measurable disease(RECIST1.1)
* Adequate bone marrow, hepatic, and renal function
* Adequate bone marrow and coagulation function as shown by:
* Absolute neutrophil count (ANC) ≥ 1.5 109/L;Platelets\>100 x109/L;Hemoglobin (Hgb) \> 9.0g/dLINR \< 2
* Adequate liver function as shown by:
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5x ULN (or \<5 if hepatic metastases are present)
* Total serum bilirubin \< 1.5 x ULN (\<3 x ULN for patients known to have Gilberts Syndrome)
* Adequate renal function as shown by:
* Serum creatinine\< 1.5 x ULN
* Fasting serum cholesterol \<300 mg/dL or 7.75 mmol/L and fasting triglycerides \<2.5 x ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved.
* Written informed consent
Exclusion Criteria:
* Patients who have received endocrine treatment other than Tamoxifen for adjuvant or metastatic/locally advanced breast cancer.
* Patients who have received goserelin at adjuvant setting
* Patients who received more than one line of chemotherapy for metastatic or locally advanced breast cancer
* Previous treatment with mTOR inhibitors.
* Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
* Symptomatic brain or other CNS metastases
* Patients receiving chronic treatment with immunosuppressive agents.
* Any severe and/or uncontrolled medical conditions, eg. currently active infection
* Pregnant or lactating
* Patients unwilling to or unable to comply with the protocol.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02313051
Study Brief:
Protocol Section:
NCT02313051