Clinical trial · Interventional
Proton Therapy for Early Stage Breast Cancer
Phase II Trial of Lumpectomy and Partial Breast Proton Therapy for Early Stage Breast Cancer
NCT00614172CI-TRIAL-00069809completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.
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 |
|---|---|---|---|
| Early-Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Radiotherapy
- description
- Two week course of proton radiotherapy to the breast.
- interventionNames
- Radiation: Proton radiation therapy
Primary outcomes (1)
- measure
- Ipsilateral Breast Tumor Recurrence-free Survival
- timeFrame
- Up to 5 years post-treatment completion, average of 48 months
- description
- Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Up to 5 years post- completion of treatment, average 48 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Invasive ductal, medullary, papillary, colloid or tubular histologies * Stages T1 or T2 (tumors \< or = 3 cm) from lumpectomy specimen. * No more then 3 positive nodes on axillary dissection or negative sentinel node. * Negative surgical margins (\>2mm) Exclusion Criteria: * Invasive lobular histology * Previous chemotherapy for breast cancer * Extensive intraductal component * Collagen vascular disease * Prior malignancy unless disease-free for 5 years * Patients who are pregnant or lactating
References
Publications (3)
- RESULTBush DA, Slater JD, Garberoglio C, Yuh G, Hocko JM, Slater JM. A technique of partial breast irradiation utilizing proton beam radiotherapy: comparison with conformal x-ray therapy. Cancer J. 2007 Mar-Apr;13(2):114-8. doi: 10.1097/PPO.0b013e318046354b. PMID 17476139
- RESULTBush DA, Slater JD, Garberoglio C, Do S, Lum S, Slater JM. Partial breast irradiation delivered with proton beam: results of a phase II trial. Clin Breast Cancer. 2011 Aug;11(4):241-5. doi: 10.1016/j.clbc.2011.03.023. Epub 2011 Jun 12. PMID 21729673
- RESULTBush DA, Do S, Lum S, Garberoglio C, Mirshahidi H, Patyal B, Grove R, Slater JD. Partial breast radiation therapy with proton beam: 5-year results with cosmetic outcomes. Int J Radiat Oncol Biol Phys. 2014 Nov 1;90(3):501-5. doi: 10.1016/j.ijrobp.2014.05.1308. Epub 2014 Jul 30. PMID 25084608