Could a few radiation sessions be enough for breast cancer?
NCT ID NCT07076485
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study is testing whether shorter courses of radiation therapy can work as well as standard treatment for people with breast cancer that has spread to lymph nodes. About 768 participants who have had surgery will receive either a very short (ultrahypofractionated) or moderately short radiation schedule. The goal is to see if these shorter treatments are safe and effective at preventing cancer from returning.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy (ultrahypofractionated or moderately hypofractionated)
- What this could lead to
- If successful, this could offer a shorter, more convenient radiation schedule for breast cancer patients, reducing treatment burden while maintaining effectiveness.
- What could go wrong
- This is a Phase 2 trial, so results are preliminary. Shorter radiation may not be as effective as standard schedules, and there is a risk of increased side effects or cancer recurrence.
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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 768 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Jan 2031
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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18 years and older
- Sex
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Anyone
- 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: Eligibility Criteria Applicable to All Cohorts Histologically confirmed invasive breast cancer (nodal involvement from presumed invasive breast cancer in the setting of occult breast cancer is sufficient to meet this criteria) 1\. Regional nodal irradiation recommended by treating radiation oncologist. 2 Negative final surgical margins. 3 No more than 12 weeks have elapsed since final breast/lymph node surgery for patients treated with surgery alone or neoadjuvant chemotherapy. No more than 12 weeks have elapsed since final cytotoxic chemotherapy for patients who received adjuvant chemotherapy. 5. Age ≥18 years. Because breast cancer is exceedingly rare in patients \< 18 years of age, children are excluded from this study. 6. Patients with a prior or concurrent malignancy are eligible provided that the natural history and treatment of the prior or concurrent malignancy does not interfere with the safety or efficacy assessment of the investigational radiation regimen used in this trial. 7. Ability to understand and the willingness to sign a written informed consent document. 8. Concurrent enrollment on other observational, translational, or therapeutic studies is allowed provided there is no direct conflict between the other protocol and the radiation regimen proscribed in this trial. Eligibility Criteria for the Low-Risk Lumpectomy Cohort 1. For patients treated with upfront surgery, pathologic stage pT0-T4b N0-N3a breast cancer without infraclavicular or internal mammary nodal involvement. 2. For patients treated with neoadjuvant chemotherapy, clinical stage cT0-T4b N0-N2a breast cancer. 3. Treated with lumpectomy (or axillary surgery only in the case of occult primary breast cancer) 4. No nodal boost recommended by the treating radiation oncologist. Eligibility Criteria for the High-Risk Lumpectomy Cohort 1. Treated with neoadjuvant chemotherapy 2. Clinical stage cT0-T4b N1-N3a/b/c 3. Treated with lumpectomy (or axillary surgery only in the case of occult primary breast cancer) 4. Nodal boost recommended by the treating radiation oncologist. Eligibility Criteria for the Low-Risk Mastectomy Cohort 1. For patients treated with upfront surgery, pathologic stage T0-T2 N0-N2a 2. For patients treated with neoadjuvant chemotherapy, clinical stage T0-T3 N0- N2a 3. For patients treated with neoadjuvant chemotherapy, residual cellularity of primary tumor ≤ 20%. 4. Treated with mastectomy 5. Negative surgical margins ≥ 2 mm. 6. No or only focal lymphovascular space invasion. 7. Age ≥ 40 years 8. Chest wall boost NOT recommended by treating radiation oncologist. Eligibility Criteria for High-Risk Mastectomy Cohort 1. For patients treated with upfront surgery, pathologic stage T0-T4d N0-N3c 2. For patients treated with neoadjuvant chemotherapy, clinical stage T0-T4d N0- N3c 3. Treated with mastectomy 4. Chest wall boost and/or nodal boost recommended by treating radiation oncologist Pregnancy Status (applicable to all cohorts) Therapeutic radiation is known to be teratogenic. As a result, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of radiation treatment. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the radiation therapy course is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception during the radiation treatment course. Pregnancy testing at the time of study enrollment is not required of women who enroll. However, all patients must comply with the Institutional Pregnancy Assessment Policy (# CLN1114) which requires pregnancy testing within 7 days prior to simulation. Exclusion Criteria: History of therapeutic radiation overlapping with the index breast or nodal basins that require radiation therapy. History of scleroderma Pregnant women are excluded from this study because ionizing radiation has the potential for teratogenic or abortifacient effects. Patients with psychiatric illness/social situations that would limit compliance with study requirements
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Banner MD Anderson Northern Colorado
RECRUITINGLoveland, Colorado, 80538, United States
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Baptist MD Anderson
RECRUITINGJacksonville, Florida, 32207, United States
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Cooper Hospital University Medical Center
RECRUITINGVoorhees Township, New Jersey, 08103, United States
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The University of Texas M. D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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University of Texas Health Science Center at San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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