Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer
NCT ID: NCT05673304
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-05-24
2027-12-31
Brief Summary
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As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.
Detailed Description
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The primary endpoint will be evaluated on surgical specimen using the residual cancer burden (RCB) index.
Thirty patients with clinical stage T1-2 Luminal B BC, suitable for conservative surgery and with a clinical indication for NAC, will be enrolled in two years. An observation cohort will also be created with patients fulfilling inclusion criteria who refuse enrollment in the interventional cohort and for patients where SBRT boost appears not feasible after enrollment for technical issues.
As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.
After the completion of neoadjuvant treatments, surgery and adjuvant therapies (endocrine therapy and whole breast irradiation) will be performed as for clinical practice
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional group
Patients will be treated on the primary tumour with a total dose of 24 Gy (8 Gy x 3 fractions QD) within 2 weeks from the start of neoadjuvant chemotherapy
SBRT anticipated boost
24 Gy in 3 fractions to the tumour
observational cohort
This cohort will include patients fulfilling inclusion criteria who refuse enrollment in the interventional cohort and patients where SBRT boost appears not feasible after enrollment for technical issues
No interventions assigned to this group
Interventions
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SBRT anticipated boost
24 Gy in 3 fractions to the tumour
Eligibility Criteria
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Inclusion Criteria
* Indication for neoadjuvant chemotherapy
Exclusion Criteria
* Breast feeding
* Patient not available for follow up
18 Years
FEMALE
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Principal Investigators
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Alessio G Morganti, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Locations
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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Alice Zamagni, MD
Role: primary
Other Identifiers
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IBISCO Trial
Identifier Type: -
Identifier Source: org_study_id