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

NCT06224244 | Active Not Recruiting Phase 2

• 1 other identifier: 1652/22
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Neoplasms; Breast Cancer

Keywords

Breast cancer; simultaneous integrated boost; hypofractionated radiotherapy; whole breast radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Simultaneous integrated boost to 40 Gy (SIB 40)

ACTIVE COMPARATOR

Patients with the following clinico-pathological characteristics * pTis G3, * pT1 pN0/pN1mic, G1-G3 luminal biology or Her-2 positive

Radiation: Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost

Simultaneous integrated boost to 43 Gy (SIB 43)

ACTIVE COMPARATOR

Patients with the following clinico-pathological characteristics: * Triple negative disease, * pT2 pN0/pN1mic, * ≤ 50 years not Luminal A

Radiation: Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost

Interventions

Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost RADIATION

Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy

Also known as: SIB40

Simultaneous integrated boost to 40 Gy (SIB 40)

Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost RADIATION

Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy

Also known as: SIB43

Simultaneous integrated boost to 43 Gy (SIB 43)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

Regina Elena Cancer Institute

Rome, Lazio, 00144, Italy

Location

Related 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 Management Group. Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): a multicentre, phase 3, non-inferiority, open-label, randomised controlled trial. Lancet. 2023 Jun 24;401(10394):2124-2137. doi: 10.1016/S0140-6736(23)00619-0. Epub 2023 Jun 8.

  PMID: 37302395 BACKGROUND

• 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 Res. 2017 Dec 27;36(1):191. doi: 10.1186/s13046-017-0640-z.

  PMID: 29282078 BACKGROUND

• 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 minimum follow up of 3 years. J Exp Clin Cancer Res. 2010 Jan 25;29(1):9. doi: 10.1186/1756-9966-29-9.

  PMID: 20100335 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two test groups. Phase 2 study because of 2 test groups with 2 types of SIB. A Simultaneous integrated boost to 40 Gy (SIB 40): 34 Gy to the ipsilateral breast with concomitant boost to 40 Gy to the tumor bed. A Simultaneous integrated boost to 43 Gy (SIB 43): 34 Gy to the ipsilateral breast with concomitant boost to 43 Gy to the tumor bed

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 25, 2024
• Study Start: February 1, 2022
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

IT (1)