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The aim of this study is to prospectively evaluate, in patients affected by early breast cancer, safety and feasibility of single fraction radiotherapy with Cyberknife R in preoperative setting, and to identify factors predictive for outcome based on biologic and clinical parameters.
Monocentric, open-label, single-arm phase II study evaluating safety and efficacy of neoadjuvant radiotherapy in early breast cancer patients. Patients eligible are women aged 50 or more years old, affected by histologically proven invasive breast cancer, with positive hormonal receptors, grading 1 or 2, HER-2 negative, without lymphovascular invasion, and tumour size up to 2 cm (measured on mammography, ultrasound or magnetic resonance), negative clinical nodal status, eligible for BCS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant radiotherapy arm | Experimental | Early breast cancer patients eligible for breast conservative surgery will undergo neoadjuvant radiotherapy with Cyberknife robotic system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant radiotherapy | Radiation | single 21 Gy fraction of Radiotherapy before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute skin toxicity events, measured according to RTOG/EORTC scale | Acute skin toxicity (from the end of radiotherapy to surgery) according to Radiation Therapy Oncology Group (RTOG)/ European Organization for research and treatment of cancer (EORTC) scale. Measuring acute skin toxicity from a minimum of 0 (no change over baseline) to a maximum of 4 (Ulceration, Hemorrage, necrosis) | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with pathologic complete response (pCR) after surgery,according to Chevalier score | Rate of pCR according to Chevalier score | 30 days |
| Number of patients with complete resection after surgical excision |
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Inclusion Criteria:
Exclusion Criteria:
Extension of breast disease within 5 mm from the skin surface 2. Tumor size > 2 cm 3. Patients affected by collagenopathies 4. Patients with BRCA1/2 mutations 5. Previous irradiation to homolateral breast 6. Previous irradiation to homolateral thoracic wall 7. DCIS and/or Paget's disease 8. Psychiatric disorders preventing informed consent signature.
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Women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Livi, Prof | Contact | +39 055 7947264 | lorenzo.livi@unifi.it | |
| Icro Meattini, Prof | Contact | +39 055 7947264 | icro.meattini@unifi.it |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Livi, Prof | AOU Careggi | Study Chair |
| Icro Meattini, Prof | AOU Careggi | Study Chair |
| Giulio Francolini, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Careggi | Recruiting | Florence | 50100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27025498 | Background | Meattini I, Guenzi M, Fozza A, Vidali C, Rovea P, Meacci F, Livi L. Overview on cardiac, pulmonary and cutaneous toxicity in patients treated with adjuvant radiotherapy for breast cancer. Breast Cancer. 2017 Jan;24(1):52-62. doi: 10.1007/s12282-016-0694-3. Epub 2016 Mar 30. | |
| 25605582 | Background | Livi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, Saieva C, Paiar F, Scotti V, De Luca Cardillo C, Bastiani P, Orzalesi L, Casella D, Sanchez L, Nori J, Fambrini M, Bianchi S. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Eur J Cancer. 2015 Mar;51(4):451-463. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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Rate of complete resection R0 with margin<1cm (except for deep margin)
| 30 days |
| Number of patients free from locoregional progression at 36 months | locoregional progression free survival measured at 36 months | 36 months |
| Number of patients free from metastatic progression at 36 months | Metastasis progression free survival measured at 36 months | 36 months |
| Number of patients dying for breast cancer at 36 months | cause-specific free survival measured at 36 months | 36 months |
| Number of patients dying for any cause at 36 months | global survival measured at 36 months | 36 months |
| Rate of chronic skin toxicity events, measured according to CTCAE | Incidence of chronic skin toxicity (over 90 days since the end of radiotherapy; fibrosis, telangiectasia, tardive oedema) according to Common terminology criteria for adverse events (CTCAE) v 4.03. From a minimum of 1 (Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
| 90 days |
| Rate of chronic extra-cutaneous toxicity, measured according to CTCAE | Incidence of chronic extra-skin toxicity (over 90 days from the end of radiotherapy; lung fibrosis, pericarditis, myocardial ischemia, valvulopathy, thoracic wall pain, fracture) according to according to Common terminology criteria for adverse events (CTCAE) v 4.03. From a minimum of 1 (Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
| 90 days |
| Correlation of differential genetic expression, immunologic and histopathologic features of tumor sample and biomarkers in blood and urine samples with toxicity and rate of response to radiotheraèy | Radiogenomic: confirm of differential genetic expression of genes already validated in previous literature (30-Radiation- induced gene signature; AOI 16-gene breast signature; IRDS gene signature) with Next Generation Sequencing (NGS, RNA-seq) or Real Time PCR on frozen biopsy tissue. Immunologic: quantitative analysis of infiltrating leucocytes (MS and M1 macrophages, CD8+ and CD4+ lymphocytes) with immunohistochemistry on fresh biopsy tissue Histopathologic: qualitative analyses (pericytes) and quantitative pattern of vascularization in immunohistochemistry. Biochemical: analysis of oxidative stress markers on peripheral blood and urines: a) 1 hour before SBRT; b) 1 hour after SBRT; c) 1 week after SBRT; d) during 24 hours before BCS; e) during 2-4 weeks after BCS. | 60 days |
| AOU Careggi |
| Principal Investigator |
| Vanessa Di Cataldo, MD | AOU Careggi | Principal Investigator |
| D017437 |
| Skin and Connective Tissue Diseases |