Clinical trial · Interventional
Cyberknife for Early Stage Breast Cancer
Cyberknife Radiosurgery for Early Stage Breast Cancer: A Winthrop-University Hospital Pilot Study of Cyberknife Partial Breast Radiosurgery for Tumors 3 cm or Less
- 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)
This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. It will evaluate outcome in terms of local control in the treated breast. Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed with 7 weeks of the lumpectomy and sent/axillary node sampling over the period of five to ten days using the Cyberknife (CK) or within the 7 weeks of the last chemotherapy treatment if given.
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 |
|---|---|---|---|
| Cyberknife for Early Stage Breast Cancer | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyberknife for Early Stage Breast Cancer
- description
- Cyberknife Robotic Radiosurgery will be utilized as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer.
- interventionNames
- Radiation: Cyberknife for Early Stage Breast Cancer
Primary outcomes (1)
- measure
- Local Control Rate
- timeFrame
- 1 Year
- description
- Mastectomy-free survival rate after Cyberknife body radiosurgery \[Mastectomy and death will be considered failures\]
Secondary outcomes (3)
- measure
- Complication Rate
- timeFrame
- 1 Year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with stage 0, I, or II (Tis, Ti, or T2 \<=3cm \& NO) histologically confirmed invasive non-lobular carcinoma or ductal carcinoma in situ of the breast with a lesion \<= 3 cm, treated with wide excision. * Negative inked histologic margins of excision or reexcision and clear of invasive tumor and DClS by at least 2mm * Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before radiotherapy. * No involved axillary lymph nodes by routine histologic examination (H\&E) of sentinel node(s) or of nodes identified from axillary dissection. * Enrollment and initiation of CyberKnife therapy within 42 days of last breast cancer surgery or last chemotherapy treatment. Exclusion Criteria: * Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma. * Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. * Patients who are pregnant. * Patients who have any histologically confirmed positive axillary nodes. * Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash.
References
Publications (0)
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