Clinical trial · Interventional
Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)
- 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)
Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\<13% grade \>3 toxicity).
Conditions
Conditions (2)
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 |
| Breast Cancer Recurrent | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rPBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rPBI
- description
- 26Gy in 5 daily fractions over 1-week
- interventionNames
- Radiation: rPBI
Primary outcomes (1)
- measure
- Grade ≥3 toxicity associated with treatment
- timeFrame
- During accrual period, up to 3 years
- description
- TThe primary endpoint, grade ≥3 toxicity associated with treatment will be summarized using frequency and percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Secondary outcomes (15)
- measure
- Frequency radiation-associated toxicity (acute)
- timeFrame
- 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma) * Tumour \<3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components * \>5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted) * Clinically node negative * Negative margins (no tumour on ink) * Recovered from surgery with the incision completely healed and no signs of infection Exclusion Criteria: * Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible) * Tumour histology limited to lobular carcinoma only * T4 disease * Node positive or distant metastatic disease * Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment * Currently pregnant or lactating * Presence of an ipsilateral breast implant or pacemaker * Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy * Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips). * Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol * Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0 * Current or prior diagnosis of bilateral breast cancer
References
Publications (12)
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- BACKGROUNDLoibl S, Poortmans P, Morrow M, Denkert C, Curigliano G. Breast cancer. Lancet. 2021 May 8;397(10286):1750-1769. doi: 10.1016/S0140-6736(20)32381-3. Epub 2021 Apr 1. PMID 33812473
- BACKGROUNDFingeret MC, Nipomnick S, Guindani M, Baumann D, Hanasono M, Crosby M. Body image screening for cancer patients undergoing reconstructive surgery. Psychooncology. 2014 Aug;23(8):898-905. doi: 10.1002/pon.3491. Epub 2014 Feb 6. PMID 25066586
- BACKGROUNDMartei YM, Vanderpuye V, Jones BA. Fear of Mastectomy Associated with Delayed Breast Cancer Presentation Among Ghanaian Women. Oncologist. 2018 Dec;23(12):1446-1452. doi: 10.1634/theoncologist.2017-0409. Epub 2018 Jun 29. PMID 29959283
- BACKGROUNDArthur DW, Winter KA, Kuerer HM, Haffty B, Cuttino L, Todor DA, Anne PR, Anderson P, Woodward WA, McCormick B, Cheston S, Sahijdak WM, Canaday D, Brown DR, Currey A, Fisher CM, Jagsi R, Moughan J, White JR. Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320. PMID 31750868
- BACKGROUNDKorzets Y, Lee G, Espin-Garcia O, Purdie T, Koch AC, Hodgson D, Barry A, Fyles A. The Role of Partial Breast Radiation in the Previously Radiated Breast. Am J Clin Oncol. 2019 Dec;42(12):932-936. doi: 10.1097/COC.0000000000000584. PMID 31436745
- BACKGROUNDBrunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.