Clinical trial · Interventional
Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
- 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)
In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.
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 |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Radiation
- description
- Radiation therapy with proton beam
- interventionNames
- Radiation: Proton Radiation
Primary outcomes (1)
- measure
- Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
- timeFrame
- From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
- description
- To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or \> radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.
Secondary outcomes (8)
- measure
- The Number of Participants With Acute Skin Toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics * Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery * Life expectancy \> 12 months Exclusion Criteria: * Pregnant or breast-feeding * Prior therapeutic radiation \> 200 cGy * History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin * Prior investigation chemotherapy
References
Publications (2)
- DERIVEDHassan MZO, Awadalla M, Tan TC, Scherrer-Crosbie M, Bakar RB, Drobni ZD, Zarif A, Gilman HK, Supraja S, Nikolaidou S, Zhang L, Zlotoff DA, Hickey SB, Patel SA, Januzzi JL, Keane F, Passeri JJ, Neilan TG, MacDonald SM, Jimenez RB. Serial Measurement of Global Longitudinal Strain Among Women With Breast Cancer Treated With Proton Radiation Therapy: A Prospective Trial for 70 Patients. Int J Radiat Oncol Biol Phys. 2023 Feb 1;115(2):398-406. doi: 10.1016/j.ijrobp.2022.08.036. Epub 2022 Aug 24. PMID 36028065
- DERIVEDJimenez RB, Hickey S, DePauw N, Yeap BY, Batin E, Gadd MA, Specht M, Isakoff SJ, Smith BL, Liao EC, Colwell AS, Ho A, Januzzi JL, Passeri J, Neilan TG, Taghian AG, Lu HM, MacDonald SM. Phase II Study of Proton Beam Radiation Therapy for Patients With Breast Cancer Requiring Regional Nodal Irradiation. J Clin Oncol. 2019 Oct 20;37(30):2778-2785. doi: 10.1200/JCO.18.02366. Epub 2019 Aug 26. PMID 31449469