Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

Not Applicable

Recruiting

• Conditions: Breast Cancer; Radiotherapy
• Interventions: Radiation: SBRT anticipated boost

• Registration Number: NCT05673304
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Study Timeline

• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-06
• Study Start: 2023-05-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	SBRT anticipated boost	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

Primary Outcome Measures

Name	Time	Method
pCR	6 month after SBRT (at surgery)	pathological complete response rate (according to AJCC-TNM and RCB) after SBRT anticipated boost

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy