Adjuvant Partial-breast Irradiation Using Stereotactic Body Radiation Therapy

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The adjuvant radiotherapy (RT) of the early-stage breast cancer patients as local treatment aims to eliminate the potential microscopic residual disease in the surgery bed or satellites in its neighborhood. Nowadays accelerated partial breast irradiation (APBI) is recommended for highly selected patients. This prospective randomized study compares the targeted external beam APBI with commonly used accelerated whole-breast irradiation (WBI) in terms of feasibility, safety, tolerance, and cosmetic effects. It is designed as non-inferiority trial and its aim is to increase the level of evidence for establishment of external beam APBI in indicated patients into daily clinical practice.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Partial Breast Re-irradiation for Breast Cancer

NCT06954623

Breast Cancers

RECRUITING PHASE2

Accelerated Partial Breast Irradiation for Early Breast Cancer

NCT00418210

Breast Cancer

COMPLETED NA

Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery

NCT00392184

Breast Cancer

COMPLETED PHASE2

Radiation Therapy (WBI Versus PBI) in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer

NCT00103181

Breast Cancer

COMPLETED NA

Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer

NCT03838419

Breast Cancer

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Early-stage breast cancer patients after partial mastectomy are screened for eligibility. The inclusion criteria are age ˃ 50 years, non-lobular carcinoma histology, size ≤ 2 cm, negative margins ≥ 2 mm, L0, ER-positive, HER-2 negative. Enrolled patients are equally randomized into two arms according to radiotherapeutic regiment - external beam APBI (5× 6 Gy) and accelerated whole breast irradiation with the boost (15× 2,67Gy + 5× 2Gy). The follow-up visits are planned at the end of RT and 1, 3, 6, 9, and 12 months after radiation, in the second year every 4 months and then every 6 months. Cosmetics results and toxicity are evaluated using questionnaires, CTCAE criteria, and photodocumentation of the irradiated chest. The main objective of presented study is to evaluate the feasibility, safety, tolerance, and cosmetic effects of SBRT irradiation to the surgery bed in five fractions. In addition to standard clinical examination and evaluation of acute and late side effects, patients together with clinicians and nurses will independently complete a questionnaire on the impact of irradiation on the cosmetic effect. The technique of targeted external beam APBI should demonstrate better feasibility and less toxicity than the standard regimen in the adjuvant setting in treating early-stage breast cancer patients. Consequently, the presented study should increase the level of evidence for RT-indicated patients to the establishment of external APBI into daily clinical practice.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early-stage Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The trial is designed as binary outcome parallel group non-inferiority trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

APBI, accelerated partial breast irradiation

The APBI group will be irradiated with a dose of 30Gy in 5 fractions in 5 working days.

Group Type EXPERIMENTAL

APBI

Intervention Type RADIATION

accelerated partial breast irradiation to the surgery bed (5 x 6,0 Gy; in 5 working days)

WBI, whole breast irradiation

The control group of patients will be irradiated with a standard accelerated mode within 20 working days.

Group Type ACTIVE_COMPARATOR

WBI

Intervention Type RADIATION

accelerated whole breast irradiation with the boost to tumor bed (15x 2,67 Gy + 5x 2,0 Gy, every working day)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

APBI

accelerated partial breast irradiation to the surgery bed (5 x 6,0 Gy; in 5 working days)

Intervention Type RADIATION

WBI

accelerated whole breast irradiation with the boost to tumor bed (15x 2,67 Gy + 5x 2,0 Gy, every working day)

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥50 years
2. Karnofsky index \> 70
3. Partial mastectomy (breast-conserving surgery)
4. DCIS G1/2 ≤ 2.5 cm with negative margins (≥ 3 mm) or invasive (non-lobular) luminal-like HER2 negative carcinoma ≤ 2 cm with negative margins (≥ 2 mm) without LVI
5. In the case of invasive carcinoma, performing of axillary dissection (≥6 negative lymph nodes) or negative sentinel node biopsy

Exclusion Criteria

1. Prior to other chest or breast surgery (including breast reconstruction), the absence of surgical clips in the tumor bed
2. Prior ipsilateral chest or breast radiotherapy
3. Neoadjuvant systemic therapy
4. Adjuvant chemotherapy
5. Multifocal or multicentric involvement
6. BRCA 1 or 2 mutations or known mutations in other high penetrance genes
7. Any systemic illness (collagen vascular diseases) or unstable medical condition that might pose additional risks for the performance of radiotherapy including claustrophobia or jactation
8. Any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements
9. Pregnancy or breastfeeding
10. Inability or unwillingness of the subject to sign written informed consent

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No