Avidination for RadionuclideTHerapy in Nonpalpable Breast Cancer

NCT06390241 | Terminated Phase 1

• 1 other identifier: IRST174.14
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

non-palpable breast lesions; infiltrating breast cancer

Outcome Measures

Primary Outcomes (3)

• Safety of avidin-biotin-Dota-90Y

  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.

  4-7 weeks

• Safety of avidin-biotin-Dota-90Y

  The primary endpoint is the systemic toxicity evaluated according to NCI-CTCAE (The U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events) Version 5.0

  4-7 weeks

• Anti-tumor activity of avidin-biotin-Dota-90Y

  The co-primary endpoint is the evaluation of the complete pathological response rate, defined as the absence of residual invasive and in situ cancer or DCIS (ductal carcinoma in situ), on hematoxylin and eosin evaluation of the complete resected breast specimen and of all sampled regional lymph nodes (i.e., ypT0 ypN0 in the current AJCC staging system).

  4-7 weeks

Secondary Outcomes (2)

• Dose-response

  48-72 hours after injection

• Biodistribution

  1-3 hours after injection

Study Arms (1)

Avidin-biotin-Dota-90Y

EXPERIMENTAL

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.

Drug: Avidin-biotin-Dota-90Y

Interventions

Avidin-biotin-Dota-90Y DRUG

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.

Avidin-biotin-Dota-90Y

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have diagnosis of occult breast cancer on the basis of mammography (BIRADS's score 4 - 5)/ultrasound (SCORE 4-5).
• Pathological diagnosis of in situ or infiltrating breast carcinoma (any histotype)
• Tumor size \>5 and ≤15 mm (at least 13 mm from the skin surface)
• Female, 18≤age≤75.
• ECOG (Eastern Cooperative Oncology Group) performance status \<2
• 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.
• Participant is willing and able to give informed consent for participation in the study.

You may not qualify if:

• Histotype different from carcinoma
• Paget carcinoma
• Lesions located near to axilla region or skin \<13 mm
• Ongoing pregnancy or breastfeeding
• Previous treatment with avidin
• Referred allergy to eggs or latex
• Patients with metastases should be excluded from this clinical trial.
• 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.
• Patients with previous radiotherapy and/or operation on the same breast, with diffuse microcalcifications will be excluded.
• 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
• Multifocal tumors are not eligible for the study.
• 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%).

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (1)

IRCCS Istituto ROmagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l.

Meldola, Forlì Cesena, 47014, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Federica Matteucci

  IRCCS IRST

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 30, 2024
• Study Start: June 19, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)