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Breast cancer radiation cut to just 9 days in new trial

NCT ID NCT03345420

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

  • 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.