TheranosticTrials.org

Clinical Trial · NCT06390241

Avidination for RadionuclideTHerapy in Nonpalpable Breast Cancer

Overview

This is an interventional, open-label, non comparative phase 2 trial enrolling patients with nonpalpable breast cancer

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Phase

Phase 1

Contacts

Federica Matteucci (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06390241

Drug / Compound

DOTA-biotin

Isotope(s):
Target(s):
  • Biotin
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • ECOG (Eastern Cooperative Oncology Group) performance status \<2
  • Patients must have diagnosis of occult breast cancer on the basis of mammography (BIRADS's score 4 - 5)/ultrasound (SCORE 4-5).
  • Tumor size \>5 and ≤15 mm (at least 13 mm from the skin surface)
  • Pathological diagnosis of in situ or infiltrating breast carcinoma (any histotype)
  • Patients scheduled to receive conservative surgical treatment
  • The effects of investigational medicinal product (IMP) on the developing human fetus are unknown. For this reason and because IMP in this trial is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 4 months after completion. See Appendix E for the "Recommendations related to contraception and pregnancy testing in clinical trials". Should a woman become pregnant or suspect she is pregnant, she should inform her treating physician immediately.

Exclusion

  • Multifocal tumors are not eligible for the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Previous treatment with avidin
  • Paget carcinoma
  • Patients with previous radiotherapy and/or operation on the same breast, with diffuse microcalcifications will be excluded.
  • Patients with metastases should be excluded from this clinical trial.
  • Lesions located near to axilla region or skin \<13 mm
  • Patients with known BRCA (BReast CAncer gene), PALB2 (Partner and Localizer of BRCA2) and CHECK2 (Checkpoint Kinase 2) mutations, grade 3 risk profile or indication to perform a test for germline mutations based on disease characteristics