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

NCT ID: NCT06224244

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2027-04-01

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.

Conditions

Breast Neoplasms; Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simultaneous integrated boost to 40 Gy (SIB 40)

Patients with the following clinico-pathological characteristics

• pTis G3,
• pT1 pN0/pN1mic, G1-G3 luminal biology or Her-2 positive

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: RADIATION

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

Simultaneous integrated boost to 43 Gy (SIB 43)

Patients with the following clinico-pathological characteristics:

• Triple negative disease,
• pT2 pN0/pN1mic,
• ≤ 50 years not Luminal A

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

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

Intervention Type: RADIATION

Other Intervention Names

SIB40; SIB43

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Silvia Takanen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Regina Elena Cancer Institute

Rome, Lazio, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 37302395 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29282078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20100335 (View on PubMed)

Other Identifiers

1652/22

Identifier Type: -

Identifier Source: org_study_id