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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT03520894
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent
2. Women ≥ 50 years old
3. Histological diagnosis of invasive breast cancer
4. ER positive (≥ 10% of tumoral cells present ER) and/or PR positive (≥ 10% of tumoral cells present PR)
5. Grading 1 or 2
6. Her2 negative (IHC 0-1+; in patients with IHC 2+, absence of amplification at FISH
7. No lymphovascular invasion evidence at biopsy
8. Early breast cancer (T1 N0 M0) clinically and radiologically defined (ultrasound study/ magnetic resonance)
9. Patients eligible for BCS.
Exclusion Criteria:
Extension of breast disease within 5 mm from the skin surface 2. Tumor size \> 2 cm 3. Patients affected by collagenopathies 4. Patients with BRCA1/2 mutations 5. Previous irradiation to homolateral breast 6. Previous irradiation to homolateral thoracic wall 7. DCIS and/or Paget's disease 8. Psychiatric disorders preventing informed consent signature.
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Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT03520894
Study Brief:
Protocol Section:
NCT03520894