External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients

Phase 2

Recruiting

• Conditions: Breast Cancer; Breast Neoplasms
• Interventions: Radiation: Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost; Radiation: Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost

• Registration Number: NCT06224244
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer

Detailed Description

Patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors.

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study First Posted: 2024-01-25
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-06-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Histologically proven invasive or in situ unifocal adenocarcinoma of the breast
• Breast conserving surgery
• Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells [i+] allowed) pN1mic, M0 stage
• Postoperative negative (no ink) final surgical margins
• Patient requires a whole breast radiotherapy plus a tumor bed boost
• Female patients aged ≥ 18 years of any menopausal status
• ECOG performance status 0-2

Exclusion Criteria

• Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free
• Mastectomy
• Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded)
• Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma
• Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder
• Pregnant or lactating patients
• Presence of ipsilateral breast implant
• Prior breast or thoracic radiotherapy for any condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simultaneous integrated boost to 43 Gy (SIB 43)	Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost	Patients with the following clinico-pathological characteristics: * Triple negative disease, * pT2 pN0/pN1mic, * ≤ 50 years not Luminal A
Simultaneous integrated boost to 40 Gy (SIB 40)	Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost	Patients with the following clinico-pathological characteristics * pTis G3, * pT1 pN0/pN1mic, G1-G3 luminal biology or Her-2 positive

Primary Outcome Measures

Name	Time	Method
Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale	From the end of treatment at 3 years	Incidence of grade 2-3 late toxicity in terms of skin toxicity

Secondary Outcome Measures

Name	Time	Method
Incidence of local tumor relapse, distant metastasis and assessment of overall survival	Time from the date of the diagnosis of primary breast cancer to the date of diagnosis of local relapse, distant metastasis or death from any cause, assessed up to 60 months	Identification of local tumor relapse in the breast parenchyma within boost volume, breast parenchyma within volume receiving 34Gy; identification of distant metastasis and analysis of overall survival

Trial Locations

Locations (1)

Regina Elena Cancer Institute; 🇮🇹 Rome, Lazio, Italy