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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT01996267
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed infiltrating breast cancer
* Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.
* Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:
•\>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
•HER2 gene amplification defined as \>6 HER2 gene copies per nucleus by in situ hybridization.
* Age ≥18
* Eastern Cooperative Oncology Group performance status ≤1
* Adequate bone marrow function (ANC \>1.5 x 109/l, platelets \>100 x 109/l)
* Adequate hepatic function (ALAT, ASAT and bilirubin \<2.5 times upper limit of normal)
* Adequate renal function (creatinine clearance \>50 ml/min)
* LVEF ≥50% measured by echocardiography or MUGA
* Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Absence of any medical condition that would place the patient at unusual risk.
* Signed written informed consent
Exclusion Criteria:
* previous radiation therapy or chemotherapy
* other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
* current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
* evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures.
* evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast.
* concurrent anti-cancer treatment or another investigational drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01996267
Study Brief:
Protocol Section:
NCT01996267