Breast cancer radiation cut to just 9 days in new trial
NCT ID NCT03345420
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested a 9-day course of whole breast radiation (hypofractionated radiotherapy) in 102 patients with early-stage breast cancer (stage 0-IIB). The goal was to see if a shorter treatment time could maintain effectiveness while reducing side effects. Researchers evaluated cosmetic outcomes and quality of life up to 24 months after radiation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hypofractionated radiation therapy
- What this could lead to
- If successful, this shorter radiation course could become a standard option for early-stage breast cancer, reducing treatment burden and side effects.
- What could go wrong
- This is a phase II trial with only 102 participants, so results are preliminary. The shorter course may not be as effective or safe as standard longer regimens in all patients.
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
-
102 people
The number who actually took part.
- Started
-
Dec 2017
- Finished
-
Jun 2025
- 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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Histologically confirmed invasive carcinoma and/or ductal carcinoma in situ (DCIS) of the breast * Final pathologic Tis, T1-T3, all must be N0 and M0 status. * Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia * Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole breast tangent fields * Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in lymph nodes will be permitted). Patients with invasive carcinoma ≥ 70 yrs and with ER+ positive tumor ≤ 2.0cm may enroll without surgical lymph node evaluation, per section 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll without surgical lymph node evaluation. * Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =\< 7 days prior to registration * A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months * Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy * Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1 * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines Exclusion Criteria: * Prior radiation therapy to the chest, neck or axilla * Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed * History of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed * Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis * Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable * Co-existing medical conditions with life expectancy \< 5 years * Other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix * Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation * Neuroendocrine carcinoma or sarcoma histology * Concurrent radiation sensitizing medications concurrent with radiation, per treatment physician
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Ductal breast carcinoma in situ are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Blood test aims to catch Cancer's return earlier
- Could skipping a lymph node check spare women from unneeded surgery?
- Could shedding pounds after breast cancer keep the disease away?
- Can a Tumor-Blood-Vessel blocker boost hormone therapy for advanced breast cancer?
- Your genes may decide if breast cancer drug causes joint pain
- 3D imaging could help surgeons remove all breast cancer in one go