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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT01180335
Eligibility Criteria:
Inclusion Criteria:
* Invasive breast cancer not eligible for conservative surgery
* Her2 negative
* Amount of tumor cells \>30% on HES slides
* RIN\>6 and amount of RNA\>1 ug
* No metastases
* Subject, age \> 18 years and \<65 years old
* Signed written informed consent
* PS 0-1
* No previous treatment for breast cancer
* Adequate organ function
* FEVG \>50%
Exclusion Criteria:
* In situ carcinoma
* Multifocal cancers
* Her2+
* Presence of metastasis
* Genomic testing not feasible because of tumor cells \<30%, RIN\<6, insufficient amount of RNA
* Organ dysfunction that contraindicates chemotherapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01180335
Study Brief:
Protocol Section:
NCT01180335