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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT02063893
Eligibility Criteria:
Inclusion Criteria:
* The patient is ≥ 30 years of age at the time the informed consent to screening has been obtained;
* The patient has one of the following histologically confirmed breast cancer subtypes:
Estrogen receptor and/or progesterone positive tumor; Human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer; HER2-negative breast cancer.
\-- The patient shows normal organ function according to the following parameters(as measured within six weeks prior to treatment allocation):
* Hemoglobin: Within normal range according to institutional standards;
* Absolute leukocyte count: Within normal range according to institutional standards;
* Absolute lymphocyte count: Within normal range according to institutional standards;
* Platelet count: Within normal range according to institutional standards;
* Alanine aminotransferase: ≤ 2.5 x Upper Limit of Normal (ULN);
* Aspartate aminotransferase: ≤ 2.5 x ULN;
* Total bilirubin: ≤ 1.5 x ULN. In the case of known Gilbert's syndrome ≤ 2 x ULN;
* Serum creatinine: 1.5 x ULN;
* Calculated creatinine clearance: \> 50 mL/min .
Exclusion Criteria:
* The patient has inflammatory breast cancer, which is defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion.
* Diagnosis established by incisional biopsy.
* Prior and concomitant neoadjuvant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers, endocrine therapy, and radiotherapy, unless authorized specifically by the protocol.
* level 3 hypertension;
* severe coronary disease;
* myelosuppression;
* respiratory disease;
* brain metastasis;
* chronic infections
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT02063893
Study Brief:
Protocol Section:
NCT02063893