Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Breast Cancer; Radiotherapy

Treatments: Radiation: SBRT anticipated boost

Study type: Interventional

Funder types: Other

Identifiers

NCT05673304

IBISCO Trial

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Luminal B-like BC, cT1-2
• Indication for neoadjuvant chemotherapy

Exclusion criteria

• Pregnancy
• Breast feeding
• Patient not available for follow up

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Interventional group

Experimental group

Description:

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

Treatment:

Radiation: SBRT anticipated boost

observational cohort

No Intervention group

Description:

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