Clinical Trials /

Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer

NCT03520894

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer
  • Official Title: Radiotherapy in Preoperative Setting With CyberKnife as Treatment in Early Breast Cancer: an Explorative Study

Clinical Trial IDs

  • ORG STUDY ID: ROCK
  • NCT ID: NCT03520894

Conditions

  • Early Breast Cancer

Purpose

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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Neoadjuvant radiotherapy armExperimentalEarly breast cancer patients eligible for breast conservative surgery will undergo neoadjuvant radiotherapy with Cyberknife robotic system

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Signed informed consent
    
              2. Women ≥ 50 years old
    
              3. Histological diagnosis of invasive breast cancer
    
              4. ER positive (≥ 10% of tumoral cells present ER) and/or PR positive (≥ 10% of tumoral
                 cells present PR)
    
              5. Grading 1 or 2
    
              6. Her2 negative (IHC 0-1+; in patients with IHC 2+, absence of amplification at FISH
    
              7. No lymphovascular invasion evidence at biopsy
    
              8. Early breast cancer (T1 N0 M0) clinically and radiologically defined (ultrasound
                 study/ magnetic resonance)
    
              9. Patients eligible for BCS.
    
            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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Rate of acute skin toxicity events, measured according to RTOG/EORTC scale
    Time Frame:15 days
    Safety Issue:
    Description: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)

    Secondary Outcome Measures

    Measure:Number of patients with pathologic complete response (pCR) after surgery,according to Chevalier score
    Time Frame:30 days
    Safety Issue:
    Description:Rate of pCR according to Chevalier score
    Measure:Number of patients with complete resection after surgical excision
    Time Frame:30 days
    Safety Issue:
    Description:Rate of complete resection R0 with margin<1cm (except for deep margin)
    Measure:Number of patients free from locoregional progression at 36 months
    Time Frame:36 months
    Safety Issue:
    Description:locoregional progression free survival measured at 36 months
    Measure:Number of patients free from metastatic progression at 36 months
    Time Frame:36 months
    Safety Issue:
    Description:Metastasis progression free survival measured at 36 months
    Measure:Number of patients dying for breast cancer at 36 months
    Time Frame:36 months
    Safety Issue:
    Description:cause-specific free survival measured at 36 months
    Measure:Number of patients dying for any cause at 36 months
    Time Frame:36 months
    Safety Issue:
    Description:global survival measured at 36 months
    Measure:Rate of chronic skin toxicity events, measured according to CTCAE
    Time Frame:90 days
    Safety Issue:
    Description: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 to a maximum of 4 (Life-threatening consequences; urgent intervention indicated
    Measure:Rate of chronic extra-cutaneous toxicity, measured according to CTCAE
    Time Frame:90 days
    Safety Issue:
    Description: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 to a maximum of 4 (Life-threatening consequences; urgent intervention indicated
    Measure: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
    Time Frame:60 days
    Safety Issue:
    Description: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.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Azienda Ospedaliero-Universitaria Careggi

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