Clinical trial · Interventional
High Five (HiFi) Accelerated Partial Breast Irradiation Study
Doubly Accelerated Partial Breast Irradiation After Breast-Conserving Surgery for Early Breast Cancer - High Five (HiFi) APBI Study
NCT05142202CI-TRIAL-00072679HiFiunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Irradiation after Breast-Conserving Surgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Doubly Accelerated Partial Breast Irradiation after Breast-Conserving Surgery
- description
- 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).
- interventionNames
- Radiation: Breast Irradiation after Breast-Conserving Surgery
Primary outcomes (2)
- measure
- Adjuvant treatment - the early toxicity incidence
- timeFrame
- Up to 48 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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) * 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
References
Publications (56)
- BACKGROUNDGuinot 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. PMID 33223449
- BACKGROUNDHannoun-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. PMID 31767533
- BACKGROUNDKhan 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. PMID 30611839
- BACKGROUNDRivera 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. PMID 31611051
- BACKGROUNDStrnad 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. PMID 29691075
- BACKGROUNDShah 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.