One-Week radiation for breast cancer lymph nodes could be as effective as three weeks
NCT ID NCT07527689
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study compares a one-week ultra-hypofractionated radiation regimen (26 Gy in 5 fractions) to the standard three-week moderate hypofractionated regimen (40 Gy in 15 fractions) for treating lymph nodes after breast cancer surgery. The goal is to see if the shorter course is just as effective at preventing cancer recurrence while reducing treatment burden. About 1,950 participants will be enrolled to evaluate safety and outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,950 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2039
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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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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures. 2. Age ≥ 18 years. 3. Histologically confirmed invasive breast cancer. 4. Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy, targeted axillary dissection and/or axillary lymph node dissection. 5. Tumor stage is classified as T1, T2, or T3, as defined by the AJCC Cancer Staging Manual, 8th Edition. 6. Meeting at least one of the following conditions: 1. Pathological nodal status of pN2 or pN3a; 2. Pathological nodal status of pN1 with one or more of the following high-risk factors: (I), Age \< 40 years. (II), Tumor location in the central or inner quadrant. (III), Estrogen Receptor (ER) negative. (IV), Presence of lymphovascular invasion (LVI). (V), Histological grade III. (VI), Patients presenting with clinical stage cN2-3a before neoadjuvant treatment. 7. Pathologically negative surgical margins, defined as "no ink on tumor." 8. Karnofsky Performance Status (KPS) score ≥ 80. 9. Documented biomarker status for Estrogen Receptor (ER), Progesterone Receptor (PR), HER2, and Ki-67. 10. Sufficient wound healing from surgery, with no signs of active infection at the intended radiation site. Exclusion Criteria: 1. Nodal stage is classified as N3b or N3c, as defined by the AJCC Cancer Staging Manual, 8th Edition. 2. Has undergone or is planning immediate breast reconstruction with a permanent implant or tissue expander. 3. Evidence of distant metastatic disease. 4. Diagnosis of synchronous bilateral invasive breast cancer or a history of prior invasive cancer in either breast. 5. History of prior radiation therapy to the chest, axillary, or supraclavicular regions. 6. Known active collagen vascular diseases, particularly systemic lupus erythematosus or scleroderma, which are contraindications to radiotherapy. 7. Presence of any severe, uncontrolled co-morbidity or medical condition that, in the investigator's judgment, would render the participant unsuitable for the study, compromise protocol compliance, or confound the interpretation of study results. 8. History of any other malignancy within the 5 years before enrollment, with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. 9. Participants who are pregnant or lactating at the time of study enrollment. (Note: In accordance with the standards of each participating institution, women of childbearing age are required to undergo pregnancy testing within 2 weeks prior to randomization.)
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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
1 site. 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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Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITINGShanghai, China
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