NCT06390241

Avidination for RadionuclideTHerapy in Nonpalpable Breast Cancer

Avidination for Radionuclide THerapy (A.R.THE.) in Nonpalpable Breast Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Nonpalpable breast lesions (NPBLs) represent approximately 30% of the overall tumoral breast lesions undergoing surgery. The Vacuum-Assisted Breast Biopsy (VABB) is a device for needle breast biopsy usefully applied in NPBL. The procedure is highly effective for the diagnosis of NPBLs, with minimal negative effects. The specimen volume obtained through this procedure is great enough to replace the diagnostic surgical excisional biopsy and frozen section intraoperative examination. Biopsies obtained through this method sometimes allow the complete excision of the lesion, representing a valid alternative to the excisional biopsy in case of benign lesion less than 15 mm in size. After VABB procedure about 10-30% of patients have a complete removal of the neoplastic lesion. About 30% of patients are disease free after surgery because the lesion has been totally removed through diagnostic VABB procedure. The rationale of this project is to treat residual microscopic disease through a radionuclide therapy. Our idea is to administer, following VABB procedure, an avidin-biotin-DOTA-90Y (where DOTA stands for 1,4,7,10-tetra-azacyclododecane-N,N',N'',N'''-tetraacetic acid and Y stands for yttrium) compound into the lesion site in order to eliminate residual tumour cells. The ARTHE approach should increase the rate of disease free cases after excisional biopsy. The primary objective of this open-label phase I trial is to evaluate the safety of avidin-biotin-DOTA-90Y combination in patients with nonpalpable breast cancer undergoing Vacuum-Assisted- Breast- Biopsy (VABB). The co-primary objective is the evaluation of the preliminary anti-tumor activity of the treatment. The secondary objective is to evaluate the dosimetry and biodistribution of avidin-biotin-DOTA-90Y after loco-regional injection under ultrasound guidance. ARTHE procedure consists of the ultrasound guided injection of Avidin into the breast tissue corresponding to VABB site followed by an injection of Biotin-DOTA-90Y. The injected Biotin-DOTA-90Y will be in a range 28-126 MBq (megabecquerel) (0.2- 0.3 mL, specific activity of 3.7 GBq/mg) (gigabequerel/milligrams). The investigators will inject 6-10 mg of avidin in a volume of 0.3-0.5 mL, followed by biotin-DOTA-90Y immediately after avidin injection. The hypothesis that a treatment with avidin-biotin-DOTA-90Y is able to destroy residual cancer cells after VABB will be verified by surgery. The duration of ARTHE procedure is 3 days, including dosimetry evaluation. Patients will receive conservative surgical treatment (4-7 weeks from ARTHE treatment).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Avidin-biotin-Dota-90Y	Within 7-8 days after the VABB procedure, 6-10 mg avidin in 1 ml saline will be administered at the site of the occult carcinoma. Subsequently, 90Y DOTA-biotin in the range of 28-57-126 MBq (3 activity levels investigated) will be injected locally immediately after avidin injection.

Timeline

• Start date: 2024-06-19
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2024-04-30
• Last updated: 2025-02-03

Locations

1 site across 1 country: Italy