Clinical trial · Interventional
Partial Breast Proton Therapy for Early Stage Breast Cancer
Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.
NCT01310530CI-TRIAL-00102371active not recruitingN/AClinicalTrials.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 is to determine the efficacy and toxicity of proton therapy when used to deliver partial breast radiotherapy in patients with early stage breast cancer with low or intermediate risk factors.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Beam Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Partial Breast Proton Therapy
- description
- Two weeks of daily proton therapy delivered to the lumpectomy site.
- interventionNames
- Radiation: Proton Beam Radiotherapy
Primary outcomes (1)
- measure
- Rate of recurrence in the breast
- timeFrame
- 5 years
Secondary outcomes (3)
- measure
- Rate of breast recurrence of low versus intermediate risk patients
- timeFrame
- 5 years
- measure
- Side-effects related to treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Breast carcinoma * DCIS * Age 40 years or higher * Primary tumor 3 cm or less * Lumpectomy with clip placement * Axillary node sampling * Negative margins Exclusion Criteria: * Distant metastasis * Multicentric disease * Prior radiation or chemotherapy * Active collagen vascular disease * Pregnant or lactating * BRCA mutation * Lymph nodes with more than microscopic tumor involvement
References
Publications (1)
- BACKGROUNDBush 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