Clinical trial NCT03520894: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Breast Cancer
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 25
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 \&gt; 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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Primary outcomes:
measure: Rate of acute skin toxicity events, measured according to RTOG/EORTC scale
timeFrame: 15 days
Secondary outcomes:
measure: Number of patients with pathologic complete response (pCR) after surgery,according to Chevalier score
timeFrame: 30 days
measure: Number of patients with complete resection after surgical excision
timeFrame: 30 days
measure: Number of patients free from locoregional progression at 36 months
timeFrame: 36 months
measure: Number of patients free from metastatic progression at 36 months
timeFrame: 36 months
measure: Number of patients dying for breast cancer at 36 months
timeFrame: 36 months
measure: Number of patients dying for any cause at 36 months
timeFrame: 36 months
measure: Rate of chronic skin toxicity events, measured according to CTCAE
timeFrame: 90 days
measure: Rate of chronic extra-cutaneous toxicity, measured according to CTCAE
timeFrame: 90 days
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
timeFrame: 60 days
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
Study officials:
affiliation: AOU Careggi
name: Lorenzo Livi, Prof
role: STUDY_CHAIR
affiliation: AOU Careggi
name: Icro Meattini, Prof
role: STUDY_CHAIR
affiliation: AOU Careggi
name: Giulio Francolini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOU Careggi
name: Vanessa Di Cataldo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.