Shorter radiation course could spare breast appearance in Low-Risk cancer
NCT ID NCT06008158
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether giving radiation once a day for five days (instead of every other day) can keep the breast looking good after treatment. It includes 48 women aged 40 or older with low-risk, hormone-sensitive breast cancer. The goal is to see if this shorter schedule is both convenient and cosmetically acceptable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Accelerated partial breast irradiation (APBI)
- What this could lead to
- If successful, this could offer a shorter, more convenient radiation schedule that maintains good breast appearance for women with low-risk breast cancer.
- What could go wrong
- This is a small, early-phase trial with only 48 participants, so results may not apply to all patients. The main focus is on cosmetic appearance, not long-term cancer control.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
48 people
The number who actually took part.
- Started
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Sep 2023
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
-
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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40 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: * Documented informed consent of the participant and/or legally authorized representative * Age: \>= 40 years * Female * Ability to read and understand English or Spanish for questionnaires * Anatomic pathologic stage 0 (ductal carcinoma in situ \[DCIS\]) or stage IA (invasive) breast cancer * Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed * Tissue from core biopsy or resection must show hormone sensitive receptors. Hormone sensitive receptors are defined as the following: * \- DCIS: Estrogen receptor (ER) positive (\>= 60%) * Invasive breast cancer: * Oncotype DX =\< 25 (if performed) OR * If Oncotype DX is not performed an Allred score of 7 or 8. The following combinations of proportion of ER positive cells and staining intensity are allowed: * ER positive (34-66% of cells) and staining intensity is strong (Allred 7) * ER positive (\>= 67% of cells) and staining intensity is intermediate (Allred 7) * ER positive (\>= 67% of cells) and staining intensity is strong (Allred 8) * Tissue from core biopsy or resection must be HER2 negative by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines * Patients must have undergone breast conserving surgery with resulting negative surgical margins (no tumor on ink). Re-excision for negative margins is allowed. Patients with pathologically involved surgical margins are excluded * Patients must have pathologic Tis or T1 disease * Patients with invasive breast cancer, including patients with microinvasion, must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection) and have pathologically confirmed uninvolved lymph nodes. All lymph nodes must be pathologically negative (pN0\[i-\]). pN0(i+), pN1mic, pN1-pN3 axillary lymph nodes are not allowed Although an axillary lymph node dissection is not anticipated for low-risk ER positive breast cancers, axillary lymph node dissection is permissible * Patient must have physician-reported "excellent" or "good" cosmesis post-lumpectomy and prior to radiation therapy based on the 4-point Global Cosmetic Score * Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by females of childbearing potential\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy * Childbearing potential is defined as not being surgically sterilized or have not been free from menses for \> 1 year Exclusion Criteria: * Any prior treatment with radiation therapy, anti-endocrine/hormone therapy, chemotherapy or biologic therapy for the currently diagnosed breast cancer PRIOR to surgical resection * Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude partial breast irradiation * Clinically significant uncontrolled illness * Diagnosis of Paget's disease of the nipple * Other prior or active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Pregnant or breastfeeding * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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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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City of Hope Medical Center
Duarte, California, 91010, United States
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