Clinical trial · Interventional
Cyberknife After Breast Conservative Surgery
Partial Breast Irradiation With Cyber Knife After Breast Conserving Surgery: A Pilot Study in Early Breast Cancer
NCT02896322CI-TRIAL-00023835unknownN/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)
Accelerated partial breast irradiation with CyberKnife (CK-APBI) is a promising innovative approach for early breast cancer after conservative surgery, for addressing the need of a radiotherapy target only to the surgical cavity in selected patients, exceeding the limits of other PBI/APBI.
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 |
|---|---|---|---|
| Partial breast irradiation with cyberknife | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyberknife
- description
- APBI with cyberknife after breast conserving surgery in breast cancer
- interventionNames
- Radiation: Partial breast irradiation with cyberknife
Primary outcomes (1)
- measure
- acute and sub-acute toxicity according to NCI CTCAE Version 3.0
- timeFrame
- within 6 months after the end of irradiation
- description
- According to NCI CTCAE Version 3.0
Secondary outcomes (2)
- measure
- Late toxicity according to NCI CTCAE Version 3.0
- timeFrame
- 24 months after the end of irradiation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Patients were ≥45 years of age with stage I-IIA histologically confirmed breast carcinoma, with tumor-free (at least 2 mm or more) inked histologic margins at surgical resection. Exclusion Criteria: * Invasive lobular or multicentric carcinoma; * Extensive associated non-invasive ductal carcinoma (synchronous or previous); peritumoral vascular invasion (\>3 vessels); * BRCA mutation carriers, * \>4 involved axillary lymph nodes, * Distant metastasis, * Non-epithelial malignancies of the breast, * Synchronous contralateral invasive carcinoma, * Paget disease, * History of previous malignancy (except non-melanoma skin cancers and in situ oral cavity and cervix carcinoma); * Further exclusion criteria were pregnancy, collagen vascular disease, aesthetic additive prostheses, severe cardiac, pulmonary and liver diseases, infectious, psychiatric illness compromising the correct acquisition of informed consent.
References
Publications (1)
- DERIVEDLozza L, Fariselli L, Sandri M, Rampa M, Pinzi V, De Santis MC, Franceschini M, Trecate G, Maugeri I, Fumagalli L, Bonfantini F, Bianchi G, Pignoli E, De Martin E, Agresti R. Partial breast irradiation with CyberKnife after breast conserving surgery: a pilot study in early breast cancer. Radiat Oncol. 2018 Mar 23;13(1):49. doi: 10.1186/s13014-018-0991-4. PMID 29566762