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Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

Primary Purpose

Breast Cancer, Radiotherapy

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

SBRT anticipated boost

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Luminal B Breast Cancer, Neoadjuvant radiation therapy, Neoadjuvant chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional group

observational cohort

Arm 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

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

Outcomes

Primary Outcome Measures

pCR

pathological complete response rate (according to AJCC-TNM and RCB) after SBRT anticipated boost

Secondary Outcome Measures

acute toxicity

acute toxicity after SBRT, evaluated according to CTCAE v.5

late toxicity

late toxicity after completion of treatments (included adjuvant RT), evaluated according to CTCAE v.5

Full Information

NCT ID

NCT05673304

First Posted

January 4, 2023

Last Updated

July 19, 2023

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

1. Study Identification

Unique Protocol Identification Number

NCT05673304

Brief Title

Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2023 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Radiotherapy

Keywords

Luminal B Breast Cancer, Neoadjuvant radiation therapy, Neoadjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Interventional group

Arm Type

Experimental

Arm 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

Arm Title

observational cohort

Arm Type

No Intervention

Arm Description

Intervention Type

Radiation

Intervention Name(s)

SBRT anticipated boost

Intervention Description

24 Gy in 3 fractions to the tumour

Primary Outcome Measure Information:

Title

pCR

Description

pathological complete response rate (according to AJCC-TNM and RCB) after SBRT anticipated boost

Time Frame

6 month after SBRT (at surgery)

Secondary Outcome Measure Information:

Title

acute toxicity

Description

acute toxicity after SBRT, evaluated according to CTCAE v.5

Time Frame

immediate to 6 months after SBRT

Title

late toxicity

Description

late toxicity after completion of treatments (included adjuvant RT), evaluated according to CTCAE v.5

Time Frame

from 6 months after SBRT

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Luminal B-like BC, cT1-2 Indication for neoadjuvant chemotherapy Exclusion Criteria: Pregnancy Breast feeding Patient not available for follow up

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alice Zamagni, MD

Phone

+39 0512143564

alice.zamagni4@unibo.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alessio G Morganti, MD, PhD

Organizational Affiliation

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Official's Role

Principal Investigator

Facility Information:

Facility Name

IRCCS Azienda Ospedaliero-Universitaria di Bologna

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alice Zamagni, MD

First Name & Middle Initial & Last Name & Degree

Alessio G Morganti, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

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