Adjuvant Partial-breast Irradiation Using Stereotactic Body Radiation Therapy

August 17, 2023 updated by: Masaryk Memorial Cancer Institute

Adjuvant Partial-breast Irradiation of Early-stage Breast Cancer Using Stereotactic Body Radiation Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Brno, Czech Republic, Czechia, 65653
        • Masaryk Memorial Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Patients referred to medical attention for adjuvant radiotherapy of early-stage breast cancer at the Department of Radiation Oncology, Masaryk Memorial Cancer Institute (MMCI) were screened for eligibility. If all inclusion/exclusion criteria will be met, they were invited to participate in the present study.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APBI, accelerated partial breast irradiation
The APBI group will be irradiated with a dose of 30Gy in 5 fractions in 5 working days.
Radiation: APBI
accelerated partial breast irradiation to the surgery bed (5 x 6,0 Gy; in 5 working days)
Active Comparator: WBI, whole breast irradiation
The control group of patients will be irradiated with a standard accelerated mode within 20 working days.
Radiation: WBI
accelerated whole breast irradiation with the boost to tumor bed (15x 2,67 Gy + 5x 2,0 Gy, every working day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
APBI vs. WBI - toxicity
Time Frame: 44 months
Comparison of acute and late toxicity of the APBI of the early stage breast cancer with accelerated irradiation regimen.
44 months
APBI vs. WBI - cosmetic effects
Time Frame: 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)
44 months
APBI - feasibility
Time Frame: 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.
44 months
APBI vs. WBI - tolerance
Time Frame: 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.
44 months
APBI vs. WBI - safety
Time Frame: 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.
44 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life C30
Time Frame: 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.
44 months
Quality of life BR45
Time Frame: 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.
44 months
Effectivity
Time Frame: 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.
44 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk Memorial Cancer Institute

Investigators

  • Principal Investigator: Petr Burkon, M.D., Ph.D., Masaryk Memorial Cancer Institute, Dept. of Radiation Oncology,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

July 7, 2023

Study Completion (Actual)

July 7, 2023

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV19-03-00354

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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