Clinical trial · Interventional
Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
NCT01290835CI-TRIAL-00093703CKPBIcompletedN/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 study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control and site of failure (if any).
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 |
|---|---|---|---|
| stereotactic radiotherapy | Radiation | — | UNRESOLVED |
| Stereotactic radiotherapy delivered by CyberKnife | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic radiotherapy
- description
- Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.
- interventionNames
- Radiation: Stereotactic radiotherapy delivered by CyberKnife
- Radiation: stereotactic radiotherapy
Primary outcomes (1)
- measure
- To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
- timeFrame
- one year
- description
- Subjects will undergo a treatment plan for partial breast irradiation with cyberknife. Feasibility will be determined by monitoring the number of potential eligible subjects enrolled that can be treated while also respecting normal tissue tolerances.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of breast malignancy, stage T1 2. Surgical treatment with lumpectomy 3. age 60 or older 4. resection margins negative by at least 2mm 5. any grade 6. ER positive 7. unicentric 8. invasive ductal 9. pathologic free of nodal metastases (N0, i- or i+) 10. Post-lumpectomy cavity to whole breast ratio must be less than or equal to 30% Exclusion criteria 1. Prior radiotherapy to the breast 2. Neoadjuvant chemotherapy 3. multicentric disease 4. Pure DCIS histology 5. Presence of extensive intraductal component 6. Node positive disease (N1 or greater)
References
Publications (20)
- BACKGROUNDVeronesi U, Marubini E, Mariani L, Galimberti V, Luini A, Veronesi P, Salvadori B, Zucali R. Radiotherapy after breast-conserving surgery in small breast carcinoma: long-term results of a randomized trial. Ann Oncol. 2001 Jul;12(7):997-1003. doi: 10.1023/a:1011136326943. PMID 11521809
- BACKGROUNDClark RM, Whelan T, Levine M, Roberts R, Willan A, McCulloch P, Lipa M, Wilkinson RH, Mahoney LJ. Randomized clinical trial of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer: an update. Ontario Clinical Oncology Group. J Natl Cancer Inst. 1996 Nov 20;88(22):1659-64. doi: 10.1093/jnci/88.22.1659. PMID 8931610
- BACKGROUNDHolli K, Saaristo R, Isola J, Joensuu H, Hakama M. Lumpectomy with or without postoperative radiotherapy for breast cancer with favourable prognostic features: results of a randomized study. Br J Cancer. 2001 Jan;84(2):164-9. doi: 10.1054/bjoc.2000.1571. PMID 11161371
- BACKGROUNDLiljegren G, Holmberg L, Bergh J, Lindgren A, Tabar L, Nordgren H, Adami HO. 10-Year results after sector resection with or without postoperative radiotherapy for stage I breast cancer: a randomized trial. J Clin Oncol. 1999 Aug;17(8):2326-33. doi: 10.1200/JCO.1999.17.8.2326. PMID 10561294
- BACKGROUNDSchroen AT, Brenin DR, Kelly MD, Knaus WA, Slingluff CL Jr. Impact of patient distance to radiation therapy on mastectomy use in early-stage breast cancer patients. J Clin Oncol. 2005 Oct 1;23(28):7074-80. doi: 10.1200/JCO.2005.06.032. PMID 16192590
- BACKGROUNDBenitez PR, Chen PY, Vicini FA, Wallace M, Kestin L, Edmundson G, Gustafson G, Martinez A. Partial breast irradiation in breast conserving therapy by way of intersitial brachytherapy. Am J Surg. 2004 Oct;188(4):355-64. doi: 10.1016/j.amjsurg.2004.06.027. PMID 15474426
- BACKGROUNDChen PY, Vicini FA, Benitez P, Kestin LL, Wallace M, Mitchell C, Pettinga J, Martinez AA. Long-term cosmetic results and toxicity after accelerated partial-breast irradiation: a method of radiation delivery by interstitial brachytherapy for the treatment of early-stage breast carcinoma. Cancer. 2006 Mar 1;106(5):991-9. doi: 10.1002/cncr.21681.