Clinical trial · Interventional
Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer
Pilot Study of Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer Patients Requiring Treatment of the Internal Mammary Lymph Nodes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being performed to understand the safety of a new radiation treatment called "Multi-Beam Intensity Modulated Radiation Therapy" ( IMRT). Currently, the standard way of giving radiation is with "simplified" IMRT, which uses only 2 beams of radiation. "Multi-beam" IMRT works by using 6-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the breast, chest wall, and the lymph nodes. At the same time, multi-beam IMRT may allow the dose to the heart, lungs, and nearby tissue to be lowered, especially when the internal mammary lymph nodes need to be targeted by radiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BreastQ questionnaire- | Behavioral | — | UNRESOLVED |
| Multi-Beam Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- radiation therapy via multi-beam IMRT
- description
- This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
- interventionNames
- Radiation: Multi-Beam Intensity-Modulated Radiation Therapy
- Behavioral: BreastQ questionnaire-
Primary outcomes (1)
- measure
- Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification
- timeFrame
- 5 weeks
- description
- The purpose of this pilot study is to assess the feasibility of utilizing multi-beam IMRT in the adjuvant treatment of the breast and regional lymph nodes of women with node-positive breast cancer requiring coverage of the internal mammary lymph nodes. A feasibility rate of at least 90% is required, ie, treatment can be successfully planned and delivered for at least 90% of the patients.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female gender * Age ≥18 years * An invasive primary breast cancer of any histology arising from breast parenchyma * Patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection * Pathologic confirmation of metastatic disease in at least one regional lymph node. Regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. Thus, any T stage is allowed as long as the N stage is ≥1 and M stage is 0. * Patient signed study-specific consent form. Exclusion Criteria: * Patients with distant metastasis. * Patients who are pregnant or breastfeeding. * Patients with psychiatric or addictive disorders that would preclude obtaining informed consent. * Time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months. * Estimated life expectancy judged to be less than one year by patient's treating radiation oncologist. * Prior radiation therapy to the ipsilateral or contralateral breast or thorax. * Primary breast cancer is a lymphoma or sarcoma histology. * Patients with a history of non-skin malignancy \<5 years prior to the diagnosis of breast cancer. * Patients requiring radiation to the bilateral breasts.
References
Publications (1)
- DERIVEDHo AY, Ballangrud A, Li G, Gupta GP, McCormick B, Gewanter R, Gelblum D, Zinovoy M, Mueller B, Mychalczak B, Dutta P, Borofsky K, Parhar P, Reyngold M, Braunstein LZ, Chawla M, Krause K, Freeman N, Siu CT, Cost Z, Arnold BB, Zhang Z, Powell SN. Long-Term Pulmonary Outcomes of a Feasibility Study of Inverse-Planned, Multibeam Intensity Modulated Radiation Therapy in Node-Positive Breast Cancer Patients Receiving Regional Nodal Irradiation. Int J Radiat Oncol Biol Phys. 2019 Apr 1;103(5):1100-1108. doi: 10.1016/j.ijrobp.2018.11.045. Epub 2018 Nov 30. PMID 30508620