Breast NeoplasmsPhase 2ESIBIRENCT06224244
External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients
A Phase 2 study testing Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost and Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost in people with Breast Neoplasms and Breast Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Breast Cancer
- What is being tested?
- Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost and Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 1 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnant or lactating patients
- Presence of ipsilateral breast implant
- Prior breast or thoracic radiotherapy for any condition
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost, Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost
- Keywords
- Breast cancer, simultaneous integrated boost, hypofractionated radiotherapy, whole breast radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boostRadiation
Also called SIB40
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 boostRadiation
Also called SIB43
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Radiation: Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the end of treatment at 3 years
Secondary outcomes (1)
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Feb 2022
- Primary completion1 Apr 2025
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Takanen, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224244
- Sponsor's protocol ID
- 1652/22
- Acronym
- ESIBIRE
- Status last verified
- Jul 2025
- First submitted
- 15 Jan 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37302395Pinnaro 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.
PubMed 29282078Pinnaro 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.
PubMed 20100335
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06224244
- Acronym / sponsor ID
- ESIBIRE / 1652/22
- Conditions
- Breast Neoplasms, Breast Cancer
- Keywords
- Breast cancer, simultaneous integrated boost, hypofractionated radiotherapy, whole breast radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Simultaneous integrated boost to 40 Gy (SIB 40) | Active comparator | Radiation: Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boostPatients with the following clinico-pathological characteristics * pTis G3, * pT1 pN0/pN1mic, G1-G3 luminal biology or Her-2 positive |
| Simultaneous integrated boost to 43 Gy (SIB 43) | Active comparator | Radiation: Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boostPatients with the following clinico-pathological characteristics: * Triple negative disease, * pT2 pN0/pN1mic, * ≤ 50 years not Luminal A |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boostAlso: SIB40Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy | Radiation | Simultaneous integrated boost to 40 Gy (SIB 40) |
| Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boostAlso: SIB43Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy | Radiation | Simultaneous integrated boost to 43 Gy (SIB 43) |
Primary outcome
Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale
Time frame: From the end of treatment at 3 years
Incidence of grade 2-3 late toxicity in terms of skin toxicity
1 secondary outcome
Incidence of local tumor relapse, distant metastasis and assessment of overall survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Results publication: PubMed 37302395Coles 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.
- Results publication: PubMed 29282078Pinnaro 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.
- Results publication: PubMed 20100335Pinnaro 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost and Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost in people with Breast Neoplasms and Breast Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale (time frame: From the end of treatment at 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06224244, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.