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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT05750693
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent.
* Age older than 18 years.
* Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy.
* Tumor lesion in the breast with a palpable size of ≥ 2 cm and/or ≥ 1.5 cm by ultrasound or magnetic resonance imaging (MRI). In case of inflammatory carcinoma the extent of inflammation can be used as measurable lesion.
* American Joint Commission on Cancer stage II or III invasive breast cancer.
* Known estrogen (ER)- and progesterone (PgR)-receptor negative or positive tumors.
* Known HER-2/neu positive tumors, defined as HercepTest IHC 3+ or SISH+.
* Patients suitable for neoadjuvant chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2 or Karnowsky performance status index at least 80%.
* Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 1 month prior to registration.
* Laboratory requirements:
* Hematology: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, Hemoglobin ≥ 10 g/dL.
* Hepatic function: Total bilirubin \< 1 x UNL, ASAT (SGOT) and ALAT (SGPT)≤ 2.5 x UNL, Alkaline phosphatase ≤ 5 UNL. Patients with ASAT and / or ALAT \> 1.5 x UNL associated with alkaline phosphatase \> 2.5 x UNL are not eligible for the study.
* Renal function: Creatinine ≤ 2 mg/dL, \< 1,25 UNL (or the calculated creatinine clearance ≥ 60 mL/min).
* Paraffin tumor tissue block made available.
* Availability to provide the set up of the histological preparations for molecular analysis.
* Negative pregnancy test (urine or serum).
* Patients must be available and compliant for treatment and follow-up.
Exclusion Criteria:
* Patients candidate for adjuvant chemotherapy.
* Evidence of distant metastasis.
* Prior chemotherapy for any malignancy.
* Prior radiation therapy for breast cancer.
* Pregnant or lactating patients.
* Inadequate general condition.
* Previous malignant disease.
* Known or suspected congestive heart failure (\>NYHA I) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension, rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
* History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05750693
Study Brief:
Protocol Section:
NCT05750693