Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

European Institute of Oncology

Status: Enrolling

Conditions: Breast Cancer

Treatments: Radiation: Phase I; Radiation: Phase II

Study type: Interventional

Funder types: Other

Identifiers

NCT04679454

IEO 1308 - AIRC IG-23118

Details and patient eligibility

About

This is a phase I/II, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients.

Full description

The research plan is conceived in two sections, as follows. (i)The technical study handles the set-up, motion and dosimetric issues of the radioablation technique using CyberKnife system.

(ii)The clinical section is organized in two studies: a phase I dose escalation study to identify the maximum tolerated dose (MTD) delivering 18 Gy, 21 Gy and 24 Gy in single fraction and a phase II study to evaluate the rate of pathological complete response (pCR) when a dose level is chosen according to the results of the previous phase I study.

Study population includes patients affected by cT1-T2 (up to 2.5 cm) cN0, adenocarcinoma of the breast, diagnosed with conventional workup. Surgical tumor removal will be scheduled after 4-8 weeks after radioablation. Whole breast radiation therapy without boost will be performed after surgery.

Enrollment: 79 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven unifocal adenocarcinoma
• T1-T2
• Tumor size up to 2.5 cm
• cN0
• Age ≥ 18 years old
• Good general condition (ECOG 0-2)
• Planned BCS
• Written informed consent

Exclusion criteria

• Tumor close to skin or chest wall
• Pure non-invasive tumor
• Prior RT to the chest
• Neoadjuvant chemotherapy
• Collagenopathies
• Coagulation or autoimmunitary disorders
• Previous malignancies

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

Preoperative Radiation Treatment

Experimental group

Description:

Preoperative Radiation treatment with CyberKnife

Treatment:

Radiation: Phase II

Radiation: Phase I