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

Breast Cancer Clinical Trial

— ESIBIRE  

Official title:

A Prospective Phase II Trial of an Accelerated Hypofractionated Radiotherapy Schedule With Risk-adapted Simultaneous Integrated Boost (HF-SIB) in Early Breast Cancer Patients Undergoing Breast Conserving Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224244
• Other study ID #: 1652/22
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: Regina Elena Cancer Institute
• Contact: Silvia Takanen
• Phone: +39065266
• Email: silvia.takanen[@]ifo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy
• Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy

Locations

Country	Name	City	State
Italy	Regina Elena Cancer Institute	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Coles CE, Haviland JS, Kirby AM, Griffin CL, Sydenham MA, Titley JC, Bhattacharya I, Brunt AM, Chan HYC, Donovan EM, Eaton DJ, Emson M, Hopwood P, Jefford ML, Lightowlers SV, Sawyer EJ, Syndikus I, Tsang YM, Twyman NI, Yarnold JR, Bliss JM; IMPORT Trial M — View Citation

Pinnaro P, Giordano C, Farneti A, Faiella A, Iaccarino G, Landoni V, Giannarelli D, Vici P, Strigari L, Sanguineti G. Short course hypofractionated whole breast irradiation after conservative surgery: a single institution phase II study. J Exp Clin Cancer — View Citation

Pinnaro P, Soriani A, Landoni V, Giordano C, Papale M, Marsella A, Marucci L, Arcangeli G, Strigari L. Accelerated hypofractionated radiotherapy as adjuvant regimen after conserving surgery for early breast cancer: interim report of toxicity after a minim — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale	Incidence of grade 2-3 late toxicity in terms of skin toxicity	From the end of treatment at 3 years
Secondary	Incidence of local tumor relapse, distant metastasis and assessment of overall survival	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	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