Breast Cancer, Radiotherapy
Conditions
Keywords
Luminal B Breast Cancer, Neoadjuvant radiation therapy, Neoadjuvant chemotherapy
Brief 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.
Detailed description
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
Interventions
RADIATIONSBRT anticipated boost
24 Gy in 3 fractions to the tumour
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Luminal B-like BC, cT1-2 * Indication for neoadjuvant chemotherapy
Exclusion criteria
* Pregnancy * Breast feeding * Patient not available for follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | 6 month after SBRT (at surgery) | pathological complete response rate (according to AJCC-TNM and RCB) after SBRT anticipated boost |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acute toxicity | immediate to 6 months after SBRT | acute toxicity after SBRT, evaluated according to CTCAE v.5 |
| late toxicity | from 6 months after SBRT | late toxicity after completion of treatments (included adjuvant RT), evaluated according to CTCAE v.5 |
Countries
Italy
Contacts
Primary ContactAlice Zamagni, MD
Outcome results
None listed