Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer (ROCK)

A

Azienda Ospedaliero-Universitaria Careggi

Status

Enrolling

Conditions

Early Breast Cancer

Treatments

Radiation: Neoadjuvant radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03520894
ROCK

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

Female

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Neoadjuvant radiotherapy arm
Experimental group
Description:
Early breast cancer patients eligible for breast conservative surgery will undergo neoadjuvant radiotherapy with Cyberknife robotic system
Treatment:
Radiation: Neoadjuvant radiotherapy

Trial contacts and locations

1

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Central trial contact

Icro Meattini, Prof; Lorenzo Livi, Prof

Data sourced from clinicaltrials.gov

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