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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT03556358
Eligibility Criteria:
Key Inclusion Criteria:
* Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria).
* Available tumor tissue for central review of HER2 status.
* Planned surgical resection of breast tumor.
* Planned neoadjuvant chemotherapy.
* Documentation of HER2 gene amplification or overexpression.
* Ipsilateral, measurable tumor longest diameter \> 2 cm.
* Known estrogen receptor (ER) and progesterone receptor (PR) hormone status (may be performed during screening).
* ECOG performance status of 0 or 1.
* Adequate bone marrow, hepatic and renal functions.
* Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan.
* Effective contraception as defined by protocol.
Key Exclusion Criteria:
* Investigational therapy within 2 months of first dose of study drug.
* Bilateral breast cancer.
* Inflammatory breast cancer
* Metastases.
* Prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer.
* Cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug.
* Clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension.
* Major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug.
* Pre-existing clinically significant Grade 2 peripheral neuropathy.
* Malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer).
* Severe dyspnea at rest requiring oxygen therapy.
* Known positive HIV, acute or chronic active infection with Hepatitis B or Hepatitis C.
* Current pregnancy or breastfeeding.
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03556358
Study Brief:
Protocol Section:
NCT03556358