Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673304
• Other study ID #: IBISCO Trial
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2022
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Alice Zamagni, MD
• Phone: +39 0512143564
• Email: alice.zamagni4[@]unibo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiotherapy

Intervention

Radiation:
• SBRT anticipated boost
24 Gy in 3 fractions to the tumour

Locations

Country	Name	City	State
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	pathological complete response rate (according to AJCC-TNM and RCB) after SBRT anticipated boost	6 month after SBRT (at surgery)
Secondary	acute toxicity	acute toxicity after SBRT, evaluated according to CTCAE v.5	immediate to 6 months after SBRT
Secondary	late toxicity	late toxicity after completion of treatments (included adjuvant RT), evaluated according to CTCAE v.5	from 6 months after SBRT