Breast CancerHiFiNCT05142202
High Five (HiFi) Accelerated Partial Breast Irradiation Study
A study testing Breast Irradiation after Breast-Conserving Surgery in people with Breast Cancer, run by The Greater Poland Cancer Centre at 1 site in Poland.
Trial summary
To establish the role of adjuvant multicatheter interstitial high-dose-rate brachytherapy in doubly accelerated and radiobiologically equivalent irradiation scheme of 5 x 5,4 Gy in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 x 4-4,3 Gy) in… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Irradiation after Breast-Conserving Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2021to 31 Dec 2025
- 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
- stage 0-II breast cancer
- Invasive ductal carcinoma (NOS, NST, other subtypes), invasive lobular carcinoma, ductal carcinoma in situ (DCIS)
- Invasive carcinoma/DCIS, which is unifocal and unicentric
- pT1-2, maximal tumor size < 3 cm
- pN0 (no metastases to the nodes)
- LVI(-) - no lymphovascular invasion
Show all 11Show fewer
- M0 (no distant metastases)
- Surgical margins free of cancer (no tumor on ink) in each direction; in the case of DCIS, the minimum margin of 2 mm in each direction
- Lack of indications to chemotherapy/immunotherapy pre- or postsurgically (e.g., triple-negative, HER2-positive breast cancer)
- Treatment start not later than 12 weeks after surgery (optimally 4-8 weeks, after wound healing)
- Informed handwritten signed patient's consent
Who cannot join
- stage III-IV breast cancer
- pT2-4, maximal tumor size ≥ 3 cm
- surgical margins cannot be properly microscopically assessed
- EIC(+) - presence of extensive intraductal component
- Paget's disease or microscopically assessed skin involvement
- pN1-3M1 (presence of nodal or distant metastases)
Show all 13Show fewer
- pre- or postsurgical indications for chemotherapy/immunotherapy
- other cancer (less than five years at time of recruitment) except skin cancer or cured FIGO 0-I cervical cancer
- time of pregnancy or lactation
- collagen disorders (congenital or acquired)
- psychiatric disorder disabling patient's compliance
- breast appearance or postsurgical status disabling safe interstitial multicatheter implantation
- lack of informed handwritten signed patient's consent
Trial locations and contacts
1 site in 1 country.
Poland1 site
Greater Poland Cancer Centre
Poznan, Greater Poland Voivodeship, 61-866
About this study
Official title: Doubly Accelerated Partial Breast Irradiation After Breast-Conserving Surgery for Early Breast Cancer - High Five (HiFi) APBI Study
To establish the role of adjuvant multicatheter interstitial high-dose-rate brachytherapy in doubly accelerated and radiobiologically equivalent irradiation scheme of 5 x 5,4 Gy in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 x 4-4,3 Gy) in selected women with breast low-risk invasive cancer or carcinoma in-situ, in terms of 3-month early and 2-year late toxicity.
Read the detailed description
Early low-risk breast cancer treatment with high-dose-rate brachytherapy (HDR-BT) (according to GEC-ESTRO, ASTRO, ABS recommendations) as a sole adjuvant treatment to the tumor bed after breast-conserving surgery (BCS) is acknowledged by prominent oncological societies in Poland and the world (PTB - Polish Brachytherapy Society, PTRO - Polish Society for Radiation Oncology, PTO - Polish Society of Oncology, ESTRO, ABS, ASTRO, ASCO). Treatment with multicatheter interstitial HDR-BT in the form of accelerated partial breast irradiation (APBI) was successfully verified in multi-institutional randomized clinical trials (Hungarian trial, GEC-ESTRO trial). It defined the currently widely used oncologically effective and clinically safe irradiation scheme of 8 x Gy in 5 days or 7 x 4,3 Gy in 4 days. In the USA, the irradiation scheme of 10 x 3,4 Gy is widely used in 5-10 days (e.g., NSABP-B39). Some European and American centers are investigating and publishing preliminary results of extremely shortened irradiation schemes of 4 x 6,25 Gy or 3 x 7,5 Gy in 2-3 treatment days, perioperatively (vAPBI trial - Valencia, TRIUMPH-T trial - Phoenix). In the Brachytherapy Department at Greater Poland Cancer Center (GPCC), the listed regimen of 7-8 x 4-4,3 Gy in 4-5 days has been used successfully since 2008. It results in very high local control rates and very low radiation-induced toxicity. APBI after BSC ensures, in properly selected low-risk patients, an equivalent local control rate and lower toxicity compared to whole breast irradiation with external beam radiation therapy (EBRT) The study hypothesis is that an additional moderately shortened irradiation scheme of 5 x 5,4 Gy in 3 consecutive days (two fractions daily with minimal 6 hours gap between fractions) does not increase early toxicity and 2-years late toxicity (primary endpoint). Also, it ensures the same or potentially higher 2-years local control probability compared to the standard regimen (control group).
What is essential, all the above-listed regimens are equivalent in terms of EQD2 calculations. The advantage of higher fraction doses that enable scheme shortening is relatively low radiobiological α/β ratio, estimated for breast cancer at around 4.
The study's primary goal is to prove the possibility of further gradual shortening of the total time of postoperative adjuvant treatment, thus, in the face of increasing breast cancer morbidity, increasing its accessibility. Indirectly, the shortened regimen may decrease the financial burden of the patient and the health system, reduce the patient's oncological treatment-related stress, absence from work, and separation from family. The project feasibility is likely since the only difference between standard and experimental procedures is in the dose and its number.
It's a prospective mono-institutional non-randomized open-label pilot study which results would be a base for further research on larger patients' groups in an anticipated multi-institutional randomized study.
The primary endpoint is to establish the role of adjuvant HDR brachytherapy in the allowable doubly accelerated and radiobiologically equivalent irradiation scheme of 5 x 5,4 Gy in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 x 4-4,3 Gy) in patients with breast low-risk invasive cancer or carcinoma in-situ, in terms of 3-month early and 2-year late toxicity.
Secondary endpoints: 1. Assessment of 2-years local control rate; 2. Review of 2-years cosmetic result; 3. Evaluation of the quality of life (QOL); 4. Evaluation of the overall survival (OS), disease-free survival (DFS), and distant metastases free survival (DFMS); 5. Analysis of the performed surgical approaches (tumorectomy, quadrantectomy, oncoplasty) preceding HDR-BT and their influence on the cosmetic results.
It is assumed to recruit a minimum of 60 participants in 2-3 years. The historical control group from the last three years counts over a hundred patients. The study is planned to be continued for up to 5 years to reach a substantially extended follow-up of 2 years.
Assumed causes of study termination: the occurrence of two or more cases of the treated area fat necrosis in which surgical intervention would be necessary (conservative treatment ineffective); too low recruitment (less than one-third of planned); occurrence of two or more similar and earlier not observed cases.
- Conditions
- Breast Cancer
- Being tested
- Breast Irradiation after Breast-Conserving Surgery
- Keywords
- breast cancer, breast-conserving surgery, brachytherapy, High Five, APBI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Irradiation after Breast-Conserving SurgeryRadiation
All recruited participants will be treated with adjuvant to breast-conserving surgery accelerated partial breast irradiation with multicatheter interstitial brachytherapy technique and prescribed five times 5,4 Gy delivered in 3 consecutive days (6 hours minimum gap between the fractions). Treatment starts not later than 12 weeks after surgery (optimally 4-8 weeks), after wound healing, and obtaining the final pathological report with full immunohistochemistry and proper risk group assignment.
| Study group | Role | What they receive |
|---|---|---|
| Doubly Accelerated Partial Breast Irradiation after Breast-Conserving Surgery | Experimental | All recruited participants will be treated with adjuvant to breast-conserving surgery accelerated partial breast irradiation with multicatheter interstitial brachytherapy technique and prescribed five times 5,4 Gy delivered in 3 consecutive days (6 hours minimum gap between the fractions). Treatment starts not later than 12 weeks after surgery (optimally 4-8 weeks), after wound healing, and obtaining the final pathological report with full immunohistochemistry and proper risk group assignment.
The control group consists of standard adjuvant APBI with multicatheter interstitial brachytherapy technique 8 x 4 Gy in 5 consecutive days or 7 x 4,3 Gy in 4 consecutive days (6 hours minimum gap between the fractions). Receives: Radiation: Breast Irradiation after Breast-Conserving Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjuvant treatment - the early toxicity incidence
The early toxicity incidence (radiodermatitis, hematoma, breast infection, intraoperative breast damage, breast pain) according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE) in 3 months frame.
Measured: Up to 48 months
Adjuvant treatment - the late toxicity incidence
The late toxicity incidence (skin, subcutaneous tissue) according to the RTOG/EORTC Late Radiation Morbidity Scoring Schema in 24 months frame.
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Greater Poland Cancer Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Chicheł, PhD, MD, Principal investigator, Greater Poland Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142202
- Sponsor's protocol ID
- HiFi-APBI
- Acronym
- HiFi
- Status last verified
- Jan 2024
- First submitted
- 8 Nov 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guinot JL, Gonzalez-Perez V, Meszaros N, Major T, Najjari-Jamal D, Gutierrez-Miguelez C, Santos MA, Smanyko V, Laplana M, Polgar C; GEC-ESTRO Breast Working Group2. Very accelerated partial breast irradiation Phase I-II multicenter trial (VAPBI): Feasibility and early results. Brachytherapy. 2021 Mar-Apr;20(2):332-338. doi: 10.1016/j.brachy.2020.10.010. Epub 2020 Nov 19.
PubMed 33223449Hannoun-Levi JM, Lam Cham Kee D, Gal J, Schiappa R, Hannoun A, Fouche Y, Gautier M, Boulahssass R, Chand ME. Accelerated partial breast irradiation in the elderly: 5-Year results of the single fraction elderly breast irradiation (SiFEBI) phase I/II trial. Brachytherapy. 2020 Jan-Feb;19(1):90-96. doi: 10.1016/j.brachy.2019.10.007. Epub 2019 Nov 23.
PubMed 31767533Khan AJ, Chen PY, Yashar C, Poppe MM, Li L, Abou Yehia Z, Vicini FA, Moore D, Dale R, Arthur D, Shah C, Haffty BG, Kuske R. Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):67-74. doi: 10.1016/j.ijrobp.2018.12.050. Epub 2019 Jan 4.
PubMed 30611839Rivera S, Hannoun-Levi JM. Hypofractionated radiation therapy for invasive breast cancer: From moderate to extreme protocols. Cancer Radiother. 2019 Dec;23(8):874-882. doi: 10.1016/j.canrad.2019.09.002. Epub 2019 Oct 11.
PubMed 31611051Strnad V, Major T, Polgar C, Lotter M, Guinot JL, Gutierrez-Miguelez C, Galalae R, Van Limbergen E, Guix B, Niehoff P, Lossl K, Hannoun-Levi JM. ESTRO-ACROP guideline: Interstitial multi-catheter breast brachytherapy as Accelerated Partial Breast Irradiation alone or as boost - GEC-ESTRO Breast Cancer Working Group practical recommendations. Radiother Oncol. 2018 Sep;128(3):411-420. doi: 10.1016/j.radonc.2018.04.009. Epub 2018 Apr 21.
PubMed 29691075Shah C, Vicini F, Shaitelman SF, Hepel J, Keisch M, Arthur D, Khan AJ, Kuske R, Patel R, Wazer DE. The American Brachytherapy Society consensus statement for accelerated partial-breast irradiation. Brachytherapy. 2018 Jan-Feb;17(1):154-170. doi: 10.1016/j.brachy.2017.09.004. Epub 2017 Oct 23.
PubMed 29074088Lancellotta V, Seipelt L, Hannoun-Levi JM, Tagliaferri L, Chand ME, Perrucci E, Valentini V, Aristei C, Kovacs G, Soror T. Multi-institutional evaluation of the reproducibility and the accuracy of the objective breast cosmesis scale. Brachytherapy. 2018 Nov-Dec;17(6):944-948. doi: 10.1016/j.brachy.2018.07.016. Epub 2018 Aug 24.
PubMed 30150016Correa C, Harris EE, Leonardi MC, Smith BD, Taghian AG, Thompson AM, White J, Harris JR. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Pract Radiat Oncol. 2017 Mar-Apr;7(2):73-79. doi: 10.1016/j.prro.2016.09.007. Epub 2016 Sep 17.
PubMed 27866865Polgar C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Fietkau R, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Uter W, Strnad V; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). Late side-effects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2017 Feb;18(2):259-268. doi: 10.1016/S1470-2045(17)30011-6. Epub 2017 Jan 14.
PubMed 28094198Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. November 27, 2017. Access: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#ctc_50
Vicini F, Shah C, Tendulkar R, Wobb J, Arthur D, Khan A, Wazer D, Keisch M. Accelerated partial breast irradiation: An update on published Level I evidence. Brachytherapy. 2016 Sep-Oct;15(5):607-15. doi: 10.1016/j.brachy.2016.06.007. Epub 2016 Jul 27.
PubMed 27475478Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 2016 Jan 16;387(10015):229-38. doi: 10.1016/S0140-6736(15)00471-7. Epub 2015 Oct 19.
PubMed 26494415Brierley JD, Gospodarowicz MK, Wittekind C (Editors). (AJCC) TNM Classification of Malignant Tumours, 8th Edition. 2016, Wiley-Blackwell, www.wiley.com
Strnad V, Hannoun-Levi JM, Guinot JL, Lossl K, Kauer-Dorner D, Resch A, Kovacs G, Major T, Van Limbergen E; Working Group Breast Cancer of GEC-ESTRO. Recommendations from GEC ESTRO Breast Cancer Working Group (I): Target definition and target delineation for accelerated or boost Partial Breast Irradiation using multicatheter interstitial brachytherapy after breast conserving closed cavity surgery. Radiother Oncol. 2015 Jun;115(3):342-8. doi: 10.1016/j.radonc.2015.06.010. Epub 2015 Jun 20.
PubMed 26104975Perrucci E, Lancellotta V, Bini V, Falcinelli L, Farneti A, Margaritelli M, Capezzali G, Palumbo I, Aristei C. Quality of life and cosmesis after breast cancer: whole breast radiotherapy vs partial breast high-dose-rate brachytherapy. Tumori. 2015 Mar-Apr;101(2):161-7. doi: 10.5301/tj.5000233. Epub 2015 Mar 11.
PubMed 25768319
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doubly Accelerated Partial Breast Irradiation After Breast-Conserving Surgery for Early Breast Cancer - High Five (HiFi) APBI Study
- ClinicalTrials.gov ID
- NCT05142202
- Acronym / sponsor ID
- HiFi / HiFi-APBI
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast-conserving surgery, brachytherapy, High Five, APBI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 147 participants (actual)
- Lead sponsor
- The Greater Poland Cancer CentreUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish the role of adjuvant multicatheter interstitial high-dose-rate brachytherapy in doubly accelerated and radiobiologically equivalent irradiation scheme of 5 x 5,4 Gy in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 x 4-4,3 Gy) in selected women with breast low-risk invasive cancer or carcinoma in-situ, in terms of 3-month early and 2-year late toxicity.
Detailed description
Early low-risk breast cancer treatment with high-dose-rate brachytherapy (HDR-BT) (according to GEC-ESTRO, ASTRO, ABS recommendations) as a sole adjuvant treatment to the tumor bed after breast-conserving surgery (BCS) is acknowledged by prominent oncological societies in Poland and the world (PTB - Polish Brachytherapy Society, PTRO - Polish Society for Radiation Oncology, PTO - Polish Society of Oncology, ESTRO, ABS, ASTRO, ASCO). Treatment with multicatheter interstitial HDR-BT in the form of accelerated partial breast irradiation (APBI) was successfully verified in multi-institutional randomized clinical trials (Hungarian trial, GEC-ESTRO trial). It defined the currently widely used oncologically effective and clinically safe irradiation scheme of 8 x Gy in 5 days or 7 x 4,3 Gy in 4 days. In the USA, the irradiation scheme of 10 x 3,4 Gy is widely used in 5-10 days (e.g., NSABP-B39). Some European and American centers are investigating and publishing preliminary results of extremely shortened irradiation schemes of 4 x 6,25 Gy or 3 x 7,5 Gy in 2-3 treatment days, perioperatively (vAPBI trial - Valencia, TRIUMPH-T trial - Phoenix). In the Brachytherapy Department at Greater Poland Cancer Center (GPCC), the listed regimen of 7-8 x 4-4,3 Gy in 4-5 days has been used successfully since 2008. It results in very high local control rates and very low radiation-induced toxicity. APBI after BSC ensures, in properly selected low-risk patients, an equivalent local control rate and lower toxicity compared to whole breast irradiation with external beam radiation therapy (EBRT) The study hypothesis is that an additional moderately shortened irradiation scheme of 5 x 5,4 Gy in 3 consecutive days (two fractions daily with minimal 6 hours gap between fractions) does not increase early toxicity and 2-years late toxicity (primary endpoint). Also, it ensures the same or potentially higher 2-years local control probability compared to the standard regimen (control group).
What is essential, all the above-listed regimens are equivalent in terms of EQD2 calculations. The advantage of higher fraction doses that enable scheme shortening is relatively low radiobiological α/β ratio, estimated for breast cancer at around 4.
The study's primary goal is to prove the possibility of further gradual shortening of the total time of postoperative adjuvant treatment, thus, in the face of increasing breast cancer morbidity, increasing its accessibility. Indirectly, the shortened regimen may decrease the financial burden of the patient and the health system, reduce the patient's oncological treatment-related stress, absence from work, and separation from family. The project feasibility is likely since the only difference between standard and experimental procedures is in the dose and its number.
It's a prospective mono-institutional non-randomized open-label pilot study which results would be a base for further research on larger patients' groups in an anticipated multi-institutional randomized study.
The primary endpoint is to establish the role of adjuvant HDR brachytherapy in the allowable doubly accelerated and radiobiologically equivalent irradiation scheme of 5 x 5,4 Gy in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 x 4-4,3 Gy) in patients with breast low-risk invasive cancer or carcinoma in-situ, in terms of 3-month early and 2-year late toxicity.
Secondary endpoints: 1. Assessment of 2-years local control rate; 2. Review of 2-years cosmetic result; 3. Evaluation of the quality of life (QOL); 4. Evaluation of the overall survival (OS), disease-free survival (DFS), and distant metastases free survival (DFMS); 5. Analysis of the performed surgical approaches (tumorectomy, quadrantectomy, oncoplasty) preceding HDR-BT and their influence on the cosmetic results.
It is assumed to recruit a minimum of 60 participants in 2-3 years. The historical control group from the last three years counts over a hundred patients. The study is planned to be continued for up to 5 years to reach a substantially extended follow-up of 2 years.
Assumed causes of study termination: the occurrence of two or more cases of the treated area fat necrosis in which surgical intervention would be necessary (conservative treatment ineffective); too low recruitment (less than one-third of planned); occurrence of two or more similar and earlier not observed cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doubly Accelerated Partial Breast Irradiation after Breast-Conserving Surgery | Experimental | Radiation: Breast Irradiation after Breast-Conserving SurgeryAll recruited participants will be treated with adjuvant to breast-conserving surgery accelerated partial breast irradiation with multicatheter interstitial brachytherapy technique and prescribed five times 5,4 Gy delivered in 3 consecutive days (6 hours minimum gap between the fractions). Treatment starts not later than 12 weeks after surgery (optimally 4-8 weeks), after wound healing, and obtaining the final pathological report with full immunohistochemistry and proper risk group assignment. The control group consists of standard adjuvant APBI with multicatheter interstitial brachytherapy technique 8 x 4 Gy in 5 consecutive days or 7 x 4,3 Gy in 4 consecutive days (6 hours minimum gap between the fractions). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- stage 0-II breast cancer
- Invasive ductal carcinoma (NOS, NST, other subtypes), invasive lobular carcinoma, ductal carcinoma in situ (DCIS)
- Invasive carcinoma/DCIS, which is unifocal and unicentric
- pT1-2, maximal tumor size < 3 cm
- pN0 (no metastases to the nodes)
Key exclusion criteria (13 listed)
- stage III-IV breast cancer
- pT2-4, maximal tumor size ≥ 3 cm
- surgical margins cannot be properly microscopically assessed
- EIC(+) - presence of extensive intraductal component
- Paget's disease or microscopically assessed skin involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Irradiation after Breast-Conserving SurgeryAll recruited participants will be treated with adjuvant to breast-conserving surgery accelerated partial breast irradiation with multicatheter interstitial brachytherapy technique and prescribed five times 5,4 Gy delivered in 3 consecutive days (6 hours minimum gap between the fractions). Treatment starts not later than 12 weeks after surgery (optimally 4-8 weeks), after wound healing, and obtaining the final pathological report with full immunohistochemistry and proper risk group assignment. | Radiation | Doubly Accelerated Partial Breast Irradiation after Breast-Conserving Surgery |
Primary outcome
Adjuvant treatment - the early toxicity incidence
Time frame: Up to 48 months
The early toxicity incidence (radiodermatitis, hematoma, breast infection, intraoperative breast damage, breast pain) according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE) in 3 months frame.
Adjuvant treatment - the late toxicity incidence
Time frame: up to 48 months
The late toxicity incidence (skin, subcutaneous tissue) according to the RTOG/EORTC Late Radiation Morbidity Scoring Schema in 24 months frame.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 33223449Guinot JL, Gonzalez-Perez V, Meszaros N, Major T, Najjari-Jamal D, Gutierrez-Miguelez C, Santos MA, Smanyko V, Laplana M, Polgar C; GEC-ESTRO Breast Working Group2. Very accelerated partial breast irradiation Phase I-II multicenter trial (VAPBI): Feasibility and early results. Brachytherapy. 2021 Mar-Apr;20(2):332-338. doi: 10.1016/j.brachy.2020.10.010. Epub 2020 Nov 19.
- Background: PubMed 31767533Hannoun-Levi JM, Lam Cham Kee D, Gal J, Schiappa R, Hannoun A, Fouche Y, Gautier M, Boulahssass R, Chand ME. Accelerated partial breast irradiation in the elderly: 5-Year results of the single fraction elderly breast irradiation (SiFEBI) phase I/II trial. Brachytherapy. 2020 Jan-Feb;19(1):90-96. doi: 10.1016/j.brachy.2019.10.007. Epub 2019 Nov 23.
- Background: PubMed 30611839Khan AJ, Chen PY, Yashar C, Poppe MM, Li L, Abou Yehia Z, Vicini FA, Moore D, Dale R, Arthur D, Shah C, Haffty BG, Kuske R. Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):67-74. doi: 10.1016/j.ijrobp.2018.12.050. Epub 2019 Jan 4.
- Background: PubMed 31611051Rivera S, Hannoun-Levi JM. Hypofractionated radiation therapy for invasive breast cancer: From moderate to extreme protocols. Cancer Radiother. 2019 Dec;23(8):874-882. doi: 10.1016/j.canrad.2019.09.002. Epub 2019 Oct 11.
- Background: PubMed 29691075Strnad V, Major T, Polgar C, Lotter M, Guinot JL, Gutierrez-Miguelez C, Galalae R, Van Limbergen E, Guix B, Niehoff P, Lossl K, Hannoun-Levi JM. ESTRO-ACROP guideline: Interstitial multi-catheter breast brachytherapy as Accelerated Partial Breast Irradiation alone or as boost - GEC-ESTRO Breast Cancer Working Group practical recommendations. Radiother Oncol. 2018 Sep;128(3):411-420. doi: 10.1016/j.radonc.2018.04.009. Epub 2018 Apr 21.
- Background: PubMed 29074088Shah C, Vicini F, Shaitelman SF, Hepel J, Keisch M, Arthur D, Khan AJ, Kuske R, Patel R, Wazer DE. The American Brachytherapy Society consensus statement for accelerated partial-breast irradiation. Brachytherapy. 2018 Jan-Feb;17(1):154-170. doi: 10.1016/j.brachy.2017.09.004. Epub 2017 Oct 23.
- Background: PubMed 30150016Lancellotta V, Seipelt L, Hannoun-Levi JM, Tagliaferri L, Chand ME, Perrucci E, Valentini V, Aristei C, Kovacs G, Soror T. Multi-institutional evaluation of the reproducibility and the accuracy of the objective breast cosmesis scale. Brachytherapy. 2018 Nov-Dec;17(6):944-948. doi: 10.1016/j.brachy.2018.07.016. Epub 2018 Aug 24.
- Background: PubMed 27866865Correa C, Harris EE, Leonardi MC, Smith BD, Taghian AG, Thompson AM, White J, Harris JR. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Pract Radiat Oncol. 2017 Mar-Apr;7(2):73-79. doi: 10.1016/j.prro.2016.09.007. Epub 2016 Sep 17.
- Background: PubMed 28094198Polgar C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Fietkau R, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Uter W, Strnad V; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). Late side-effects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2017 Feb;18(2):259-268. doi: 10.1016/S1470-2045(17)30011-6. Epub 2017 Jan 14.
- BackgroundCommon Terminology Criteria for Adverse Events (CTCAE) Version 5.0. November 27, 2017. Access: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#ctc_50
- Background: PubMed 27475478Vicini F, Shah C, Tendulkar R, Wobb J, Arthur D, Khan A, Wazer D, Keisch M. Accelerated partial breast irradiation: An update on published Level I evidence. Brachytherapy. 2016 Sep-Oct;15(5):607-15. doi: 10.1016/j.brachy.2016.06.007. Epub 2016 Jul 27.
- Background: PubMed 26494415Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 2016 Jan 16;387(10015):229-38. doi: 10.1016/S0140-6736(15)00471-7. Epub 2015 Oct 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Chicheł, PhD, MD principal investigator
Greater Poland Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Irradiation after Breast-Conserving Surgery in people with Breast Cancer, run by The Greater Poland Cancer Centre at 1 site in Poland.
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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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 Poland. 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?
Results are not available in the source record.
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?
Adjuvant treatment - the early toxicity incidence (time frame: Up to 48 months). The study lists 2 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 NCT05142202, which also lists 56 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 3 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.