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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT03197805
Eligibility Criteria:
Inclusion Criteria:
* Performance status ≤ 2 (according to WHO criteria)
* Patient with early invasive breast cancer histologically confirmed stage I to IIIA)
* Positive or negative lymph node involvement
* Positive or negative Hormonal Receptors (Estrogens and/or Progesterone),
* Equivocal HER2 status (IHC Score 2 and equivocal ISH defined as HER2/Chr17 ratio \<2 and 4 ≤ HER2 gene number copy \< 6) as assessed on surgical specimen
* Adequate Hematological, Hepatic, Renal and Cardiac Functions
* Patient potentially eligible for an anti-HER2 therapy
* Patient eligible to receive an adjuvant therapy
* Signed Informed Consent
* Patient with social insurance.
Exclusion Criteria:
* Non-measurable tumor
* Unknown Hormonal Receptors
* Unknown node involvement
* Positive or negative HER2 status (Score 0, 1 or 3 IHC, or Negative or positive ISH)
* Disease stage ≥IIIB
* Patient not able to follow the trial.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03197805
Study Brief:
Protocol Section:
NCT03197805