Shorter radiation safe for Node-Positive breast cancer?
NCT ID NCT02700386
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at a shorter course of radiation for women with breast cancer that had spread to nearby lymph nodes after surgery. The goal was to see if this faster treatment was safe and had manageable side effects like arm swelling or shoulder stiffness. 108 women took part, and researchers tracked their health for up to 3 years.
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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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108 people
The number who actually took part.
- Started
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Aug 2016
- Finished
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Jun 2024
- 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 to 101 years
- 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: 1. Adult women (≥18 years old) with breast cancer who have undergone surgery for their primary breast tumor (either lumpectomy or mastectomy +/- reconstruction) and are confirmed to have involved lymph nodes on surgical pathology. 2. Patient who have undergone either a total mastectomy or a lumpectomy are eligible. Acceptable procedures for assessment of axillary nodal status at the time of surgery include: * axillary node dissection; * sentinel node biopsy alone; or * sentinel node biopsy followed by axillary node dissection. 3. Eligible women include AJCC (American Joint Committee on Cancer) 7th ed. Stage cN0 or cN1 subsequently staged after surgery as Stage pIB (N1mic), pIIA, pIIB, pIIIA, pIIIB, or N3a (10 or more axillary nodes) only: note that ypN0 will also be eligible if pathologic confirmation of nodal involvement was documented prior to neoadjuvant chemotherapy and the patient was found to be node-negative at the time of surgery. Note that women less than 50 years of age, women who received chemotherapy, patients staged as pN0 (i+ or mol+), and large-breasted women are eligible for enrollment. 4. The patient must have recovered from surgery with the incision completely healed and no signs of infection. If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved. The patient must have an ECOG performance status of 0 or 1 (KPS \>70%). 5. The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 180 days if chemotherapy is not delivered adjuvantly. If adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 180 days. 6. Before the patient is enrolled, the consent form, including any addenda, must be signed and dated by the patient and the person who explains the study to that patient. 7. Subjects will have the ability to understand, and the willingness to sign a written informed consent document. Exclusion Criteria: 1. patients \<18 years old 2. pregnant women 3. male patients 4. women with T4 disease, including inflammatory breast cancer 5. women who have declined or otherwise not received preceding surgery 6. women with positive margins after primary surgery 7. women with node-negative disease 8. women without histologic confirmation of nodal involvement 9. women more than 180 days out from primary breast surgery or adjuvant chemotherapy 10. patients with clinically detected or suspicious lymph node involvement not readily amenable to surgical treatment (≥cN2 disease) 11. patients with synchronous bilateral breast cancers 12. patients with prior ipsilateral thoracic or breast radiation 13. patients with distant metastatic disease (cM1) or a life expectancy of less than 5 years 14. active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma. 15. other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up. 16. patients with psychiatric or addictive disorders or other conditions that, in the opinion of the Investigator, would preclude the patient from meeting the study requirements. 17. patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years. Note: women \<50 years of age, women who received chemotherapy, pN0 (i+ or mol+), and large-breasted women are eligible for enrollment.
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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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Memorial Hospital
Colorado Springs, Colorado, 80909, United States
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Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
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University of Colorado Hospital
Aurora, Colorado, 80045, United States
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