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Breast CancerPhase 1ARTHENCT06390241

Avidination for RadionuclideTHerapy in Nonpalpable Breast Cancer

A Phase 1 study testing Avidin-biotin-Dota-90Y in people with Breast Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an interventional, open-label, non comparative phase 2 trial enrolling patients with nonpalpable breast cancer Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Avidin-biotin-Dota-90Y
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteItaly
Study dates
19 Jun 2024to 30 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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%).

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Meldola, Forlì Cesena, 47014

Other trials in Italy

About this study

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

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

Read the 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
Being tested
Avidin-biotin-Dota-90Y
Keywords
non-palpable breast lesions, infiltrating breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avidin-biotin-Dota-90YDrug

    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.

Study groups in NCT06390241
Study groupRoleWhat they receive
Avidin-biotin-Dota-90YExperimentalThe 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.
Receives: Drug: Avidin-biotin-Dota-90Y

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4-7 weeks

  2. 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

    Measured: 4-7 weeks

  3. 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).

    Measured: 4-7 weeks

Secondary outcomes (2)

  1. Dose-response

    Serial PET (positron emission computed tomography)/CT (computerized tomography) scan will be performed at defined time intervals after radiopharmaceutical administration. The number of PET/CT scans depends on the presence of wash-out documented by the whole body image acquired with SPECT/CT scanner. A dedicated software will be used to segment the region of interest, to quantify the activity inside the target region, and to estimate the number of disintegrations, that is the input data for absorbed dose calculation. For the tumor absorbed dose calculation, the spherical volume approximation is used with a uniform activity distribution. The tumor mass is estimated from the CT scan.

    From the computed data, a detailed report relative to absorbed dose to the tumor and neighboring organs treated with avidin-biotin-DOTA-90Y will be prepared, in order to provide a dose-response relationship for toxicity avoidance.

    Measured: 48-72 hours after injection

  2. Biodistribution

    The whole-body image will be used to evaluate 90Y biodistribution in the body and to verify that the injected activity is really localized in the breast tissue. In this case, the treatment can be considered as locoregional, with the uptake concentrated in a limited region of the breast, without the involvement of other organs. To evaluate the assumption of a localized uptake in the tumor lesion, the patients will undergo just one PET/ CT scan.

    Measured: 1-3 hours after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start19 Jun 2024
  3. Primary completion30 Jan 2025
  4. Study completion30 Jan 2025

Why it stopped: Target enrolment was not met. The trial is terminated because the radiopharmaceutical is not produced under GMP

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06390241
Sponsor's protocol ID
IRST174.14
Acronym
ARTHE
Status last verified
Jan 2025
First submitted
17 Apr 2024
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Avidin-biotin-Dota-90Y in people with Breast Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Target enrolment was not met. The trial is terminated because the radiopharmaceutical is not produced under GMP). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of avidin-biotin-Dota-90Y (time frame: 4-7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06390241.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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