NCT05673304

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
19mo left

Started May 2023

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
May 2023Dec 2027

First Submitted

Initial submission to the registry

January 4, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 18, 2024

Status Verified

October 1, 2024

Enrollment Period

4.6 years

First QC Date

January 4, 2023

Last Update Submit

December 16, 2024

Conditions

Breast CancerRadiotherapy

Keywords

Luminal B Breast CancerNeoadjuvant radiation therapyNeoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • pCR

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

    6 month after SBRT (at surgery)

Secondary Outcomes (2)

  • acute toxicity

    immediate to 6 months after SBRT

  • late toxicity

    from 6 months after SBRT

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Radiation: SBRT anticipated boost

observational cohort

NO INTERVENTION

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

Interventions

SBRT anticipated boostRADIATION

24 Gy in 3 fractions to the tumour

Interventional group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alessio G Morganti, MD, PhD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Zamagni, MD

CONTACT

+39 0512143564alice.zamagni4@unibo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 6, 2023

Study Start

May 24, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)