Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Phase I; Radiation: Phase II

• Registration Number: NCT04679454
• Lead Sponsor: European Institute of Oncology

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-22
• Study Start: 2021-07-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2026-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preoperative Radiation Treatment	Phase I	Preoperative Radiation treatment with CyberKnife
Preoperative Radiation Treatment	Phase II	Preoperative Radiation treatment with CyberKnife

Primary Outcome Measures

Name	Time	Method
Phase II: Evaluate efficacy measured in terms of pCR rate	time frame:8 weeks	Rate of pCR after radioablative treatment, according to Modified Residual Cancer Burden (RCB) index
Phase I: Identify the maximum tolerated dose (MTD)	time frame:2 weeks	Dose escalation is designed as a 3+3 rule-based study. Acute skin/soft tissue toxicity, measured according to NCI CTCAE v. 4.03. Any Grade 3-4 toxicity related to radioablation is considered dose limiting (DLT).

Secondary Outcome Measures

Name	Time	Method
Cosmetic outcomes	time frame: 1 - 3 years	Measured according to the 4 points scale (poor, fair, good, excellent)
Local relapse	time frame: 1 - 3 years	establish the rate of local relapse
Incidence of chronic toxicity	time frame: 6 months - 3 years	Chronic skin/soft tissue, bone, lung and heart toxicities incidence measured according to NCI CTCAE v. 4.03
Disease free survival	time frame: 1- 3 years	establish the rate of disease free survival
Post surgery complications	time frame: within 30 days of surgery	Reporting of any post surgery complication (rate of infection, seroma, hematoma, necrosis, delayed wound healing)
Overall survival	time frame: 3 years	establish the rate of overall survival
Breast cancer specific survival	time frame: 3 years	establish the rate of breast cancer specific survival

Trial Locations

Locations (1)

IEO, European Institute of Oncology IRCCS; 🇮🇹 Milan, Italy