Adjuvant Partial-breast Irradiation Using Stereotactic Body Radiation Therapy

NCT06007118 | Completed

• 1 other identifier: NV19-03-00354
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-stage Breast Cancer

Keywords

breast cancer; adjuvant radiotherapy; accelerated partial breast irradiation; surgical bed

Outcome Measures

Primary Outcomes (5)

• APBI vs. WBI - toxicity

  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

  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

  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

  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

  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 Outcomes (3)

• Quality of life C30

  44 months

• Quality of life BR45

  44 months

• Effectivity

  44 months

Study Arms (2)

APBI, accelerated partial breast irradiation

EXPERIMENTAL

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

Radiation: APBI

WBI, whole breast irradiation

ACTIVE COMPARATOR

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

Radiation: WBI

Interventions

APBI RADIATION

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

APBI, accelerated partial breast irradiation

WBI RADIATION

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

WBI, whole breast irradiation

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age ≥50 years
• Karnofsky index \> 70
• Partial mastectomy (breast-conserving surgery)
• 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
• In the case of invasive carcinoma, performing of axillary dissection (≥6 negative lymph nodes) or negative sentinel node biopsy
• Prior to other chest or breast surgery (including breast reconstruction), the absence of surgical clips in the tumor bed
• Prior ipsilateral chest or breast radiotherapy
• Neoadjuvant systemic therapy
• Adjuvant chemotherapy
• Multifocal or multicentric involvement
• BRCA 1 or 2 mutations or known mutations in other high penetrance genes
• Any systemic illness (collagen vascular diseases) or unstable medical condition that might pose additional risks for the performance of radiotherapy including claustrophobia or jactation
• Any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements
• Pregnancy or breastfeeding
• Inability or unwillingness of the subject to sign written informed consent

Sponsors & Collaborators

• Masaryk Memorial Cancer Institute: lead

Study Sites (1)

Masaryk Memorial Cancer Institute

Brno, Czech Republic, 65653, Czechia

Location

Related Publications (12)

• Strnad V, Polgar C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Fietkau R, Schlamann A, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Dunst J, Gall C, Uter W; Groupe Europeen de Curietherapie and European Society for Radiotherapy and Oncology. Accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy compared with whole-breast irradiation with boost for early breast cancer: 10-year results of a GEC-ESTRO randomised, phase 3, non-inferiority trial. Lancet Oncol. 2023 Mar;24(3):262-272. doi: 10.1016/S1470-2045(23)00018-9. Epub 2023 Feb 1.

  PMID: 36738756 BACKGROUND

• Meattini I, Marrazzo L, Saieva C, Desideri I, Scotti V, Simontacchi G, Bonomo P, Greto D, Mangoni M, Scoccianti S, Lucidi S, Paoletti L, Fambrini M, Bernini M, Sanchez L, Orzalesi L, Nori J, Bianchi S, Pallotta S, Livi L. Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial. J Clin Oncol. 2020 Dec 10;38(35):4175-4183. doi: 10.1200/JCO.20.00650. Epub 2020 Aug 24.

  PMID: 32840419 BACKGROUND

• Meattini I, Becherini C, Boersma L, Kaidar-Person O, Marta GN, Montero A, Offersen BV, Aznar MC, Belka C, Brunt AM, Dicuonzo S, Franco P, Krause M, MacKenzie M, Marinko T, Marrazzo L, Ratosa I, Scholten A, Senkus E, Stobart H, Poortmans P, Coles CE. European Society for Radiotherapy and Oncology Advisory Committee in Radiation Oncology Practice consensus recommendations on patient selection and dose and fractionation for external beam radiotherapy in early breast cancer. Lancet Oncol. 2022 Jan;23(1):e21-e31. doi: 10.1016/S1470-2045(21)00539-8.

  PMID: 34973228 BACKGROUND

• Thomsen MS, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Moller M, Pedersen AN, Yates E, Berg M, Lorenzen E, Jensen I, Josipovic M, Overgaard J, Offersen BV; DBCG RT Committee. Volume matters: Breast induration is associated with irradiated breast volume in the Danish Breast Cancer Group phase III randomized Partial Breast Irradiation trial. Radiother Oncol. 2022 Dec;177:231-235. doi: 10.1016/j.radonc.2022.09.024. Epub 2022 Oct 17.

  PMID: 36265685 BACKGROUND

• Vicini FA, Cecchini RS, White JR, Arthur DW, Julian TB, Rabinovitch RA, Kuske RR, Ganz PA, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Costantino JP, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Bryant JL, Wolmark N. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial. Lancet. 2019 Dec 14;394(10215):2155-2164. doi: 10.1016/S0140-6736(19)32514-0. Epub 2019 Dec 5.

  PMID: 31813636 BACKGROUND

• Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.

  PMID: 23835717 BACKGROUND

• Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28.

  PMID: 32580883 BACKGROUND

• Whelan TJ, Julian JA, Berrang TS, Kim DH, Germain I, Nichol AM, Akra M, Lavertu S, Germain F, Fyles A, Trotter T, Perera FE, Balkwill S, Chafe S, McGowan T, Muanza T, Beckham WA, Chua BH, Gu CS, Levine MN, Olivotto IA; RAPID Trial Investigators. External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomised controlled trial. Lancet. 2019 Dec 14;394(10215):2165-2172. doi: 10.1016/S0140-6736(19)32515-2. Epub 2019 Dec 5.

  PMID: 31813635 BACKGROUND

• Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2.

  PMID: 28779963 BACKGROUND

• Meattini I, Poortmans PMP, Marrazzo L, Desideri I, Brain E, Hamaker M, Lambertini M, Miccinesi G, Russell N, Saieva C, Strnad V, Visani L, Kaidar-Person O, Livi L. Exclusive endocrine therapy or partial breast irradiation for women aged >/=70 years with luminal A-like early stage breast cancer (NCT04134598 - EUROPA): Proof of concept of a randomized controlled trial comparing health related quality of life by patient reported outcome measures. J Geriatr Oncol. 2021 Mar;12(2):182-189. doi: 10.1016/j.jgo.2020.07.013. Epub 2020 Jul 29.

  PMID: 32739355 BACKGROUND

• Burkon P, Selingerova I, Vrzal M, Holanek M, Coufal O, Polachova K, Andraskova V, Jhawar SR, Slampa P, Kazda T, Slavik M. Quality of life in early breast cancer patients after adjuvant accelerated partial-breast irradiation (APBI) in randomized trial. Sci Rep. 2025 Jan 9;15(1):1387. doi: 10.1038/s41598-025-85342-2.

  PMID: 39779797 DERIVED

• Burkon P, Selingerova I, Slavik M, Holanek M, Vrzal M, Coufal O, Polachova K, Muller P, Slampa P, Kazda T. Toxicity of external beam accelerated partial-breast irradiation (APBI) in adjuvant therapy of early-stage breast cancer: prospective randomized study. Radiat Oncol. 2024 Feb 3;19(1):17. doi: 10.1186/s13014-024-02412-x.

  PMID: 38310249 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Petr Burkon, M.D., Ph.D.

  Masaryk Memorial Cancer Institute, Dept. of Radiation Oncology,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 23, 2023
• Study Start: May 1, 2019
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)