Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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

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

SBRT anticipated boost

Alice Zamagni, MD

Alessio G Morganti, MD, PhD

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

Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

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

pathological complete response rate (according to AJCC-TNM and RCB) after SBRT anticipated boost

acute toxicity after SBRT, evaluated according to CTCAE v.5

late toxicity after completion of treatments (included adjuvant RT), evaluated according to CTCAE v.5

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer	NCT05673304	Breast Cancer Radiotherapy	SBRT anticipate...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer	NCT05673304	Breast Cancer Radiotherapy	SBRT anticipate...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer	NCT05673304	Breast Cancer Radiotherapy	SBRT anticipate...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer	NCT05673304	Breast Cancer Radiotherapy	SBRT anticipate...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna

Spots Global Cancer Trial Database for sbrt anticipated boost