Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer

Early Breast Cancer Clinical Trial

— ROCK  

Official title:

Radiotherapy in Preoperative Setting With CyberKnife as Treatment in Early Breast Cancer: an Explorative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03520894
• Other study ID #: ROCK
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2019
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: Lorenzo Livi, Prof
• Phone: +39 055 7947264
• Email: lorenzo.livi[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

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Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer

Intervention

Radiation:
• Neoadjuvant radiotherapy
single 21 Gy fraction of Radiotherapy before surgery

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Careggi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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):451-63. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Number of patients with pathologic complete response (pCR) after surgery,according to Chevalier score	Rate of pCR according to Chevalier score	30 days
Secondary	Number of patients with complete resection after surgical excision	Rate of complete resection R0 with margin<1cm (except for deep margin)	30 days
Secondary	Number of patients free from locoregional progression at 36 months	locoregional progression free survival measured at 36 months	36 months
Secondary	Number of patients free from metastatic progression at 36 months	Metastasis progression free survival measured at 36 months	36 months
Secondary	Number of patients dying for breast cancer at 36 months	cause-specific free survival measured at 36 months	36 months
Secondary	Number of patients dying for any cause at 36 months	global survival measured at 36 months	36 months
Secondary	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; to a maximum of 4 (Life-threatening consequences; urgent intervention indicated	90 days
Secondary	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; to a maximum of 4 (Life-threatening consequences; urgent intervention indicated	90 days
Secondary	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