Clinical trial · Interventional
Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen
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
- 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)
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.
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 |
|---|---|---|---|
| IMRT/VMAT-Based Accelerated Partial Breast Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT/VMAT-Based Accelerated Partial Breast Irradiation
- description
- Patients will be treated with a novel IMRT/VMAT-based accelerated partial breast irradiation regimen.
- interventionNames
- Radiation: IMRT/VMAT-Based Accelerated Partial Breast Irradiation
Primary outcomes (1)
- measure
- Physician-Assessed Adverse Breast Cosmesis
- timeFrame
- 2 Years
- description
- 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.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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
References
Publications (33)
- BACKGROUNDFisher 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. PMID 12393820
- BACKGROUNDClarke 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. PMID 16360786
- BACKGROUNDNattinger 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. PMID 11535710
- BACKGROUNDPan 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. PMID 24317177
- BACKGROUNDParekh 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. PMID 30083949
- BACKGROUNDLam 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.