Clinical trial · Interventional
Avidination for RadionuclideTHerapy in Nonpalpable Breast Cancer
Avidination for Radionuclide THerapy (A.R.THE.) in Nonpalpable Breast Cancer
NCT06390241CI-TRIAL-00085406ARTHEterminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Target enrolment was not met. The trial is terminated because the radiopharmaceutical is not produced under GMP
Summary
Brief summary (as posted)
This is an interventional, open-label, non comparative phase 2 trial enrolling patients with nonpalpable breast cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avidin-biotin-Dota-90Y | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avidin-biotin-Dota-90Y
- description
- The total planned enrollment for this study is up to approximately 52 patients for Part 1 (dose-escalation) and Part 2 (dose expansion). Up to 18 patients will be enrolled in Part 1 (depending on dose-escalation) and 40 patients in dose expansion in Part 2. The 6 patients evaluated for dosimetry in Part 1 will also be evaluated in part 2.
- interventionNames
- Drug: Avidin-biotin-Dota-90Y
Primary outcomes (3)
- measure
- Safety of avidin-biotin-Dota-90Y
- timeFrame
- 4-7 weeks
- description
- The primary endpoint is the local toxicity evaluated according to Radiation Therapy Oncology Group (RTOG) scale. According to the RTOG scale grades range from 0 to 5, where 0 represents no change over baseline and 5 represents any toxicity which causes death.
- measure
- Safety of avidin-biotin-Dota-90Y
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have diagnosis of occult breast cancer on the basis of mammography (BIRADS's score 4 - 5)/ultrasound (SCORE 4-5). 2. Pathological diagnosis of in situ or infiltrating breast carcinoma (any histotype) 3. Tumor size \>5 and ≤15 mm (at least 13 mm from the skin surface) 4. Female, 18≤age≤75. 5. ECOG (Eastern Cooperative Oncology Group) performance status \<2 6. Patients scheduled to receive conservative surgical treatment 7. 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. 8. Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: 1. Histotype different from carcinoma 2. Paget carcinoma 3. Lesions located near to axilla region or skin \<13 mm 4. Ongoing pregnancy or breastfeeding 5. Previous treatment with avidin 6. Referred allergy to eggs or latex 7. Patients with metastases should be excluded from this clinical trial. 8. 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. 9. Patients with previous radiotherapy and/or operation on the same breast, with diffuse microcalcifications will be excluded. 10. 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 11. Multifocal tumors are not eligible for the study. 12. History of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS (overall survival) rate \>90%).
References
Publications (0)
Data not yet available
No reference posted for this study.