Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2032-08-01

Brief Summary

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To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.

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Detailed Description

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Accelerated Partial Breast Irradiation (APBI) has demonstrated the non-inferiority compared to external beam radiotherapy (EBRT) in the conserving-treatment of early breast carcinoma by using high-dose-rate (HDR) multicatheter interstitial brachytherapy (MIBT). The standard treatment regimen is 7-8 sessions with two treatments per day, for a total treatment time of 4-5 days. Based on 5-year results of the Groupe Européen de Curiethérapie European SocieTy for Radiotherapy \& Oncology (GEC-ESTRO) Very Accelerated Partial Breast Irradiation (VAPBI) phase I-II trial, in low-risk cases, 3-4 fractions delivered in 2 days reduced the overall treatment time with low rate of side effects and excellent oncological outcome.

Retrospective and prospective studies with a single fraction HDR MIBT-based VAPBI suggest that by further increasing the dose delivered in one fraction, the total treatment time can be reduced to a single session safely.

A phase II multicenter trial is proposed to confirm this hypothesis.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single-fraction very accelerated partial breast irradiation arm

Low risk, early-stage breast cancer patients, who receiving single-fraction very accelerated partial breast irradiation, as postoperative radiation therapy.

Group Type EXPERIMENTAL

single-fraction very accelerated partial breast irradiation

Intervention Type RADIATION

Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.

Interventions

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single-fraction very accelerated partial breast irradiation

Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Stage 0 \& I \& II (\< 3 cm) breast carcinoma
* Lesions of \< 3 cm diameter
* Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS)
* Nodal status: node-negative (pN0) or micro-metastatic (pN1mi) (patients with pN1mi status can be treated, but due to the limited clinical evidence, individual decision is needed)
* M0: Absence of distant metastasis
* Clear resection margins by National Surgical Adjuvant Breast and Bowel Project (NSABP) definition (no tumor on ink)
* Unifocal (multifocality limited within 2 cm) and unicentric breast cancer
* Age\> 40 years
* Luminal A or B tumors
* Time interval from surgery preferably less than 12 weeks and no longer than 20 weeks, and from adjuvant chemotherapy less than 4 weeks
* Human Epidermal growth factor Receptor 2 positive (HER2+) patients receiving postoperative anti-HER2 systemic therapy
* Specific signed consent form prior to randomization

Exclusion Criteria

* Stage III-IV breast cancer
* Surgical margins that cannot be microscopically assessed
* Extensive intraductal component (EIC+)
* Extensive lymphovascular invasion (LVI+) (focal is allowed)
* Triple negative breast cancer
* BReast CAncer gene (BRCA) 1-2 mutation
* Human Epidermal growth factor Receptor 2 positive (HER2+) patients not receiving postoperative anti-HER2 systemic therapy
* Neoadjuvant systemic therapy
* Paget's disease or pathological skin involvement
* Synchronous or previous breast cancer.
* Pregnant or lactating women

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Viktor Smanykó, MD, PhD

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Viktor Smanykó, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Oncology, Budapest, Hungary

Locations

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