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Early-stage Breast CancerNCT06007118

Adjuvant Partial-breast Irradiation Using Stereotactic Body Radiation Therapy

A study testing APBI and WBI in people with Early-stage Breast Cancer, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Early-stage Breast Cancer
What is being tested?
APBI and WBI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteCzechia
Study dates
1 May 2019to 7 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Masaryk Memorial Cancer Institute

    Brno, Czech Republic, 65653

Other trials in Czechia

About this study

Official title: 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.

Read the 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.

Being tested
APBI, WBI
Keywords
breast cancer, adjuvant radiotherapy, accelerated partial breast irradiation, surgical bed
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APBIRadiation

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

  • WBIRadiation

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

Study groups in NCT06007118
Study groupRoleWhat they receive
APBI, accelerated partial breast irradiationExperimentalThe APBI group will be irradiated with a dose of 30Gy in 5 fractions in 5 working days.
Receives: Radiation: APBI
WBI, whole breast irradiationActive comparatorThe control group of patients will be irradiated with a standard accelerated mode within 20 working days.
Receives: Radiation: WBI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. APBI vs. WBI - toxicity

    Comparison of acute and late toxicity of the APBI of the early stage breast cancer with accelerated irradiation regimen.

    Measured: 44 months

  2. 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)

    Measured: 44 months

  3. 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.

    Measured: 44 months

  4. 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.

    Measured: 44 months

  5. 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.

    Measured: 44 months

Secondary outcomes (3)

  1. Quality of life C30

    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.

    Measured: 44 months

  2. Quality of life BR45

    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.

    Measured: 44 months

  3. Effectivity

    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.

    Measured: 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start1 May 2019
  3. Primary completion7 Jul 2023
  4. Study completion7 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The trial is designed as binary outcome parallel group non-inferiority trial.
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06007118
Sponsor's protocol ID
NV19-03-00354
Status last verified
Jul 2023
First submitted
20 Jul 2023
Last updated
23 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36738756

  • 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.

    PubMed 32840419

  • 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.

    PubMed 34973228

  • 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.

    PubMed 36265685

  • 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.

    PubMed 31813636

  • 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.

    PubMed 23835717

  • 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.

    PubMed 32580883

  • 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.

    PubMed 31813635

  • 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.

    PubMed 28779963

  • 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.

    PubMed 32739355

  • 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.

    PubMed 39779797

  • 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.

    PubMed 38310249

Questions about this trial

What is this clinical trial studying?

A study testing APBI and WBI in people with Early-stage Breast Cancer, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

APBI vs. WBI - toxicity (time frame: 44 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06007118, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.

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