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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | 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 |
|
| observational cohort | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT anticipated boost | Radiation | 24 Gy in 3 fractions to the tumour |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice Zamagni, MD | Contact | +39 0512143564 | alice.zamagni4@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessio G Morganti, MD, PhD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| from 6 months after SBRT |
| D017437 |
| Skin and Connective Tissue Diseases |