Radiotherapy in Preoperative Setting With CyberKnife as Treatment in Early Breast Cancer: an Explorative Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Early Breast Cancer
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Rate of acute skin toxicity events, measured according to RTOG/EORTC scale
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Lorenzo Livi
Full Professor
Azienda Ospedaliero-Universitaria Careggi
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •Women ≥ 50 years old
- •Histological diagnosis of invasive breast cancer
- •ER positive (≥ 10% of tumoral cells present ER) and/or PR positive (≥ 10% of tumoral cells present PR)
- •Grading 1 or 2
- •Her2 negative (IHC 0-1+; in patients with IHC 2+, absence of amplification at FISH
- •No lymphovascular invasion evidence at biopsy
- •Early breast cancer (T1 N0 M0) clinically and radiologically defined (ultrasound study/ magnetic resonance)
- •Patients eligible for BCS.
Exclusion Criteria
- •Extension of breast disease within 5 mm from the skin surface
- •Tumor size \> 2 cm
- •Patients affected by collagenopathies
- •Patients with BRCA1/2 mutations
- •Previous irradiation to homolateral breast
- •Previous irradiation to homolateral thoracic wall
- •DCIS and/or Paget's disease
- •Psychiatric disorders preventing informed consent signature.
Outcomes
Primary Outcomes
Rate of acute skin toxicity events, measured according to RTOG/EORTC scale
Time Frame: 15 days
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 Outcomes
- Number of patients dying for breast cancer at 36 months(36 months)
- Number of patients free from metastatic progression at 36 months(36 months)
- Number of patients dying for any cause at 36 months(36 months)
- Number of patients with pathologic complete response (pCR) after surgery,according to Chevalier score(30 days)
- Number of patients free from locoregional progression at 36 months(36 months)
- 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(60 days)
- Number of patients with complete resection after surgical excision(30 days)
- Rate of chronic skin toxicity events, measured according to CTCAE(90 days)
- Rate of chronic extra-cutaneous toxicity, measured according to CTCAE(90 days)