Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

Study Overview
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Brief Summary
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IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pathological complete response (pCR) in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC). As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.

Detailed Description
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IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pCR in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC). 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

Official Title
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Immune and Pathological Response in Breast Cancer After Preoperative Irradiation With Stereotactic Technique and Neoadjuvant ChemOtherapy

Conditions
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Breast Cancer, Radiotherapy

Intervention / Treatment
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* Radiation: SBRT anticipated boost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Luminal B-like BC, cT1-2 Indication for neoadjuvant chemotherapy Exclusion Criteria: Pregnancy Breast feeding Patient not available for follow up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>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 | Radiation: SBRT anticipated boost<br>* 24 Gy in 3 fractions to the tumour<br>|
| No Intervention: observational cohort<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCR | pathological complete response rate (according to AJCC-TNM and RCB) after SBRT anticipated boost | 6 month after SBRT (at surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute toxicity | acute toxicity after SBRT, evaluated according to CTCAE v.5 | immediate to 6 months after SBRT | 
| late toxicity | late toxicity after completion of treatments (included adjuvant RT), evaluated according to CTCAE v.5 | from 6 months after SBRT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Luminal B Breast Cancer, Neoadjuvant radiation therapy, Neoadjuvant chemotherapy