New daily radiation regimen aims to cut treatment time for breast cancer patients
NCT ID NCT05591547
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a modified radiation schedule for women aged 50 and older with early-stage, low-risk breast cancer. Instead of the standard every-other-day treatment over 10 days, participants receive five daily radiation sessions with a slightly lower dose each day. The goal is to see if this shorter schedule is safe, effective, and results in better breast appearance and fewer side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 91 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sanford Health
Worthington, Minnesota, 56187, United States
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Sanford Health
Sioux Falls, South Dakota, 57104, United States
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