Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy (IORT_BREAST)

Institut Català d'Oncologia

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: Breast conservative surgery; Radiation: Intraoperative Radiotherapy (IORT); Radiation: External Beam Hypofractionated Radiotherapy (EBRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05498311

IORT BREAST CANCER

Details and patient eligibility

About

To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy

Full description

To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy

Enrollment: 89 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy.
• Not pregnant at diagnosis.
• Signed informed consent form.
• Age ≥45 years old.
• Patients candidates to Intrabeam.
• Patients with ≥60 years with the presence of one or more of the following adverse criteria after surgery:
• Tumor size > 2.5 cm.
• Extensive intraductal carcinoma (≥25%)
• Lymphovascular invasion.
• Involved focal margins (<2mm) without ampliation surgery.

Exclusion criteria

• Presence of distant metastasis.
• Primary chemotherapy.
• Lymph node involvement.
• Negative hormonal receptors.
• Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas
• Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
• Uncontrolled infection.
• Concurrent treatment with other experimental treatments
• Lack of signed informed consent form.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Intraoperative Radiotherapy (IORT)

Experimental group

Description:

Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy.

Treatment:

Radiation: Intraoperative Radiotherapy (IORT)

Radiation: External Beam Hypofractionated Radiotherapy (EBRT)

Procedure: Breast conservative surgery