Immune and Pathological Response in Breast Cancer After Preoperative Irradiation With Stereotactic Technique and Neoadjuvant ChemOtherapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Luminal B-like BC, cT1-2
• Indication for neoadjuvant chemotherapy
Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Alice Zamagni, MD
alice.zamagni4@unibo.it
+39 0512143564
Time Frame
Start Date: 2023-05-24
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 30
Treatments
Experimental: 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
No_intervention: 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
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna