Adjuvant Partial-breast Irradiation Using Stereotactic Body Radiation Therapy

Not Applicable

Completed

• Conditions: Early-stage Breast Cancer
• Interventions: Radiation: WBI; Radiation: APBI

• Registration Number: NCT06007118
• Lead Sponsor: Masaryk Memorial Cancer Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-05-01
• Status Verified: 2023-07
• Primary Completion: 2023-07-07
• Study Completion: 2023-07-07
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Study First Posted: 2023-08-23
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WBI, whole breast irradiation	WBI	The control group of patients will be irradiated with a standard accelerated mode within 20 working days.
APBI, accelerated partial breast irradiation	APBI	The APBI group will be irradiated with a dose of 30Gy in 5 fractions in 5 working days.

Primary Outcome Measures

Name	Time	Method
APBI vs. WBI - tolerance	44 months	Comparison of tolerance of the APBI of the early stage breast cancer with accelerated irradiation regimen. The toxicity was evaluated by CTCAE criteria (Common Terminology Criteria for Adverse Events). The outcome to define the tolerance a safety was CTCAE grade II or greater skin toxicity.
APBI - feasibility	44 months	Evaluation of feasibility of the APBI regimen based on the proportion of patients who completed radiation in a total of 10 days and the proportion of patients who were irradiated exactly according to technical guidelines.
APBI vs. WBI - toxicity	44 months	Comparison of acute and late toxicity of the APBI of the early stage breast cancer with accelerated irradiation regimen.
APBI vs. WBI - cosmetic effects	44 months	Comparison of cosmetic effects of the APBI of the early stage breast cancer with accelerated irradiation regimen. Cosmetic effects independently evaluated by patient, physician, and nurse scored using Harvard scale (4-point Likert scale). The scale contains 4 values - nearly identical as untreated (the best outcome), slightly different, clearly different, seriously distorted (the worst outcome)
APBI vs. WBI - safety	44 months	Comparison of safety of the APBI of the early stage breast cancer with accelerated irradiation regimen. The toxicity was evaluated by CTCAE criteria (Common Terminology Criteria for Adverse Events). The outcome to define the tolerance a safety was CTCAE grade II or greater skin toxicity.

Secondary Outcome Measures

Name	Time	Method
Quality of life C30	44 months	Quality of Life assessment using the standardized European Organisation for Research and Treatment of Cancer (EORTC) questionnaire QLQ-C30. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Quality of life BR45	44 months	Quality of Life assessment using the standardized European Organisation for Research and Treatment of Cancer (EORTC) questionnaire with special module for patients with breast cancer (Breast QLQ-BR45). All of the scales and single item measures range in score from 0 to 100. A high score for the functional scales and functional single items represents a high/healthy level of functioning, whereas a high score for the symptom scales and symptom item represents a high level of symptomatology or problems.
Effectivity	44 months	Assessment of effectivity of the treatment method by evaluating subsequent endpoints such as LC (local control) and OS (overall survival). Overall survival (OS) is defined as the time from randomization to death from any cause. Local control (LC) is defined as the time from randomization to the first local recurrence.

Trial Locations

Locations (1)

Masaryk Memorial Cancer Institute; 🇨🇿 Brno, Czech Republic, Czechia