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Breast CancerPhase 2APBI RISENCT05591547

Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen

A Phase 2 study testing IMRT/VMAT-Based Accelerated Partial Breast Irradiation in people with Breast Cancer, run by Sanford Health at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. 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?
IMRT/VMAT-Based Accelerated Partial Breast Irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
2 sitesUnited States
Study dates
30 Mar 2022to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Ability to provide informed written consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3 or a Karnofsky performance score of ≥ 30%.
  • Willingness to return to Sanford Cancer Center for follow-up.
  • Radiation therapy is planned as part of routine care.
  • On histological examination, the tumor must be either ductal carcinoma in-situ (DCIS) or an invasive ductal carcinoma of the breast.
  • Patients must be ≥ 50 years old.
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  • Presence of unifocal tumor.
  • Surgical treatment of the breast must have been a lumpectomy. Placement of surgical clips to delineate the lumpectomy bed is highly recommended, though not required.
  • The final margins of the resected specimen must be histologically free of tumor (≥ 2 mm for invasive adenocarcinoma and ≥ 3 mm for DCIS). Re-excision of surgical margins is permitted. Gross disease must be unifocal with a pathologic invasive tumor size tumor size ≤ 2.0 cm or pathologic DCIS size ≤ 2.5 cm.
  • Patients with invasive breast cancer are required to have axillary staging consisting of a sentinel lymph node biopsy. The sentinel lymph node(s) must be negative for regionally metastatic disease, both on routine H\&E evaluation and immunohistochemical staining. Axillary staging is not required for patients with DCIS.
  • Absence of lymphovascular space invasion.
  • The tumor must be positive for either the presence of the estrogen or progesterone receptor, and either 0 or +1 for the HER-2/neu receptor on immunohistochemical staining.
  • The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity to the whole breast reference volume ratio must be ≤ 30% based on the CT-simulation scan.
  • Life expectancy of 5 years or longer excluding breast cancer diagnosis(co-morbid conditions taken into considerations by the PI)
  • Women of child-bearing potential must have a negative pregnancy test before their CT simulation, and must agree to use an effective method of birth control during their radiation therapy treatment course.

Who cannot join

  • Pregnant women, or women of childbearing potential who are unwilling to employ adequate contraception.
  • Nuclear grade 3 DCIS or Nottingham grade 3 invasive ductal carcinoma.
  • Invasive lobular carcinoma, any grade.
  • Male sex.
  • Any treatment with radiation therapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study enrollment
  • Prior breast or thoracic radiation treatment for any reason.
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  • History of prior invasive breast cancer or DCIS. (Patients with a history of LCIS treated by surgery alone are eligible.)
  • Paget's disease of the nipple.
  • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
  • Patients with a collagen vascular disease; specifically, SLE or scleroderma.
  • Breast implants. (Patients who have had implants removed are eligible.)
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
  • Women with a known or suspected predisposition to developing breast cancer (i.e., BRCA1/2 mutations, p53 mutation, etc...)
  • Women who are pregnant, or women of child-bearing potential who refuse to use an effective method of birth control

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sanford Health

    Sioux Falls, South Dakota, 57104

  • Sanford Health

    Worthington, Minnesota, 56187

Other trials in United States

About this study

Official title: SH APBI RISE: Evaluating the Safety and Efficacy of a Novel IMRT/VMAT-based Accelerated Partial Breast Irradiation Regimen for patIents With Favorable Risk breaSt cancEr

This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day for five treatments, over ten calendar days. The APBI in this study is modified and will deliver five once daily treatments over consecutive treatment days, with a slightly lower dose of radiation each day as compared to the standard external beam-based APBI treatment.

Read the detailed description

This is a prospective observational cohort study in breast cancer participants. The purpose of this study is to report physician-assessed cosmetic outcomes.

Conditions
Breast Cancer
Being tested
IMRT/VMAT-Based Accelerated Partial Breast Irradiation
Keywords
Invasive Ductal Carcinoma, Ductal Carcinoma In-Situ, Intensity Modulated Radiation Therapy, Volumetric Modulated Arc Therapy, Accelerated Partial Breast Irradiation, External Beam Radiation Therapy
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating

What participants receive

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

  • IMRT/VMAT-Based Accelerated Partial Breast IrradiationRadiation

    The lumpectomy bed will receive a total of 26 Gy in 5 fractions, with 1 fraction delivered per day. Ideally, the course of radiation therapy would be completed over 5 consecutive treatment days. Treatment must begin within 12 weeks of lumpectomy or re-excision of surgical margins and must be completed within 10 calendar days.

Study groups in NCT05591547
Study groupRoleWhat they receive
IMRT/VMAT-Based Accelerated Partial Breast IrradiationExperimentalPatients will be treated with a novel IMRT/VMAT-based accelerated partial breast irradiation regimen.
Receives: Radiation: IMRT/VMAT-Based Accelerated Partial Breast Irradiation

What is being measured

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

  1. Physician-Assessed Adverse Breast Cosmesis

    To evaluate the incidence of physician-assessed adverse breast cosmesis by utilizing the Harvard Breast Cosmesis survey. The survey scores breast cosmesis from 1 to 4, with 1 representing "excellent" cosmesis, 2 representing "good" cosmesis, 3 representing "fair" cosmesis, and 4 representing "poor" cosmesis. Adverse breast cosmesis is defined as a score of either 3 or 4 on the Harvard Breast Cosmesis survey.

    Measured: 2 Years

Secondary outcomes (6)

  1. Recurrence Rate

    To evaluate the cumulative incidence of ipsilateral breast tumor recurrence, regional nodal recurrence, and distant recurrence by following participants after treatment with yearly mammograms and breast exams performed during routine clinic appointments.

    Measured: 2 Years

  2. Disease Free Survival Rate

    To evaluate disease free survival and overall survival by following participants after treatment with yearly mammograms and breast exams performed during routine clinic appointments.

    Measured: 2 Years

  3. Acute Adverse Events

    To evaluate the incidence and severity of acute adverse events associated with our novel IMRT/VMAT-based APBI regimen, using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 grading system. The CTCAE Version 5.0 grading system scores adverse events from 1 to 5, with higher scores representing more severe adverse events.

    Measured: 12 Weeks

  4. Late Adverse Events

    To evaluate the incidence and severity of late adverse events associated with our novel IMRT/VMAT-based APBI regimen, using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 grading system. The CTCAE Version 5.0 grading system scores adverse events from 1 to 5, with higher scores representing more severe adverse events.

    Measured: 2 Years

  5. Patient Quality of Life

    To evaluate patient quality of life associated with our novel IMRT/VMAT-based APBI regimen by using the breast cancer treatment outcome scale (BCTOS). The BCTOS contains 22 items, which are assigned to three internally consistent subscales: 1) Functional Status, 2) Aesthetic Status, and 3) Breast Sensitivity Status. Patients are instructed to rate each item of the BCTOS on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference, 4 = large difference). The score for each subscale is the mean of the ratings over all items belonging to that subscale. A higher score reflects a poorer status (i.e. a larger difference between the treated and the untreated breast). The survey also allows patients to address their satisfaction with their breast cancer treatment and results.

    Measured: 2 Years

  6. Patient-Assessed Adverse Breast Cosmesis

    To evaluate the incidence of patient-assessed adverse breast cosmesis by utilizing the Harvard Breast Cosmesis survey. The survey scores breast cosmesis from 1 to 4, with 1 representing "excellent" cosmesis, 2 representing "good" cosmesis, 3 representing "fair" cosmesis, and 4 representing "poor" cosmesis. Adverse breast cosmesis is defined as a score of either 3 or 4 on the Harvard Breast Cosmesis survey.

    Measured: 2 Years

Timeline

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

  1. First posted24 Oct 2022
  2. Study start30 Mar 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single group non-randomized interventional prospective cohort study
Masking
None (open label)
Enrolment
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05591547
Sponsor's protocol ID
SH APBI RISE
Acronym
APBI RISE
Status last verified
May 2026
First submitted
5 Oct 2022
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No plan to share IPD with other researchers

Publications

  • Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.

    PubMed 12393820

  • Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.

    PubMed 16360786

  • Nattinger AB, Kneusel RT, Hoffmann RG, Gilligan MA. Relationship of distance from a radiotherapy facility and initial breast cancer treatment. J Natl Cancer Inst. 2001 Sep 5;93(17):1344-6. doi: 10.1093/jnci/93.17.1344. No abstract available.

    PubMed 11535710

  • Pan IW, Smith BD, Shih YC. Factors contributing to underuse of radiation among younger women with breast cancer. J Natl Cancer Inst. 2014 Jan;106(1):djt340. doi: 10.1093/jnci/djt340. Epub 2013 Dec 7.

    PubMed 24317177

  • Parekh A, Fu W, Hu C, Shen CJ, Alcorn S, Rao AD, Asrari F, Camp MS, Wright JL. Impact of race, ethnicity, and socioeconomic factors on receipt of radiation after breast conservation surgery: analysis of the national cancer database. Breast Cancer Res Treat. 2018 Nov;172(1):201-208. doi: 10.1007/s10549-018-4881-0. Epub 2018 Aug 6.

    PubMed 30083949

  • Lam J, Cook T, Foster S, Poon R, Milross C, Sundaresan P. Examining Determinants of Radiotherapy Access: Do Cost and Radiotherapy Inconvenience Affect Uptake of Breast-conserving Treatment for Early Breast Cancer? Clin Oncol (R Coll Radiol). 2015 Aug;27(8):465-71. doi: 10.1016/j.clon.2015.04.034. Epub 2015 May 23.

    PubMed 26009548

  • Hoopes DJ, Kaziska D, Chapin P, Weed D, Smith BD, Hale ER, Johnstone PA. Patient preferences and physician practice patterns regarding breast radiotherapy. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):674-81. doi: 10.1016/j.ijrobp.2010.11.077. Epub 2011 Jan 27.

    PubMed 21277106

  • Bonin K, McGuffin M, Presutti R, Harth T, Mesci A, Feldman-Stewart D, Chow E, Di Prospero L, Vesprini D, Rakovitch E, Lee J, Paszat L, Doherty M, Soliman H, Ackerman I, Cao X, Kiss A, Szumacher E. Breast Cancer Patients' Preferences for Adjuvant Radiotherapy Post Lumpectomy: Whole Breast Irradiation vs. Partial Breast Irradiation-Single Institutional Study. J Cancer Educ. 2018 Feb;33(1):37-43. doi: 10.1007/s13187-016-1016-3.

    PubMed 26976434

  • Rippy EE, Ainsworth R, Sathananthan D, Kollias J, Bochner M, Whitfield R. Influences on decision for mastectomy in patients eligible for breast conserving surgery. Breast. 2014 Jun;23(3):273-8. doi: 10.1016/j.breast.2013.12.009. Epub 2014 Jan 21.

    PubMed 24456967

  • Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013 Oct;14(11):1086-1094. doi: 10.1016/S1470-2045(13)70386-3. Epub 2013 Sep 19.

    PubMed 24055415

  • Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.

    PubMed 20147717

  • Hughes KS, Schnaper LA, Bellon JR, Cirrincione CT, Berry DA, McCormick B, Muss HB, Smith BL, Hudis CA, Winer EP, Wood WC. Lumpectomy plus tamoxifen with or without irradiation in women age 70 years or older with early breast cancer: long-term follow-up of CALGB 9343. J Clin Oncol. 2013 Jul 1;31(19):2382-7. doi: 10.1200/JCO.2012.45.2615. Epub 2013 May 20.

    PubMed 23690420

  • Kunkler IH, Williams LJ, Jack WJ, Cameron DA, Dixon JM; PRIME II investigators. Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a randomised controlled trial. Lancet Oncol. 2015 Mar;16(3):266-73. doi: 10.1016/S1470-2045(14)71221-5. Epub 2015 Jan 28.

    PubMed 25637340

  • Fisher B, Wickerham DL, Deutsch M, Anderson S, Redmond C, Fisher ER. Breast tumor recurrence following lumpectomy with and without breast irradiation: an overview of recent NSABP findings. Semin Surg Oncol. 1992 May-Jun;8(3):153-60.

    PubMed 1496226

  • Hepel JT, Wazer DE. Update on Partial Breast Irradiation. Clin Breast Cancer. 2021 Apr;21(2):96-102. doi: 10.1016/j.clbc.2020.04.003. Epub 2020 Apr 17.

    PubMed 32448706

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMRT/VMAT-Based Accelerated Partial Breast Irradiation in people with Breast Cancer, run by Sanford Health at 2 sites in United States.

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 15 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Physician-Assessed Adverse Breast Cosmesis (time frame: 2 Years). 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 NCT05591547, which also lists 33 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 6 May 2026.

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