Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2024-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Early Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant radiotherapy arm

Early breast cancer patients eligible for breast conservative surgery will undergo neoadjuvant radiotherapy with Cyberknife robotic system

Group Type EXPERIMENTAL

Neoadjuvant radiotherapy

Intervention Type RADIATION

single 21 Gy fraction of Radiotherapy before surgery

Interventions

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Neoadjuvant radiotherapy

single 21 Gy fraction of Radiotherapy before surgery

Intervention Type RADIATION

Eligibility Criteria

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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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Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No