Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Using radiation therapy before chemotherapy for Luminal B breast cancer

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

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT05673304 · Data updated 2026-11-12

This study is testing if giving radiation therapy before chemotherapy can help women with Luminal B breast cancer have better results before surgery.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment30 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Bologna)
StatusRecruiting
StartedMay 24, 2023
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedDecember 18, 2024
Trial IDNCT05673304 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with clinical stage T1-2 Luminal B breast cancer who are indicated for neoadjuvant chemotherapy.

Probably not a fit

Patients who are pregnant, breastfeeding, or unable to attend follow-up appointments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The IBISCO TRIAL is designed to evaluate the effectiveness of stereotactic radiation therapy (SBRT) as a preoperative boost in patients with Luminal B breast cancer undergoing neoadjuvant chemotherapy. This phase II trial aims to improve the rate of pathological complete response (pCR) by treating patients with SBRT prior to surgery. Thirty patients with clinical stage T1-2 Luminal B breast cancer will be enrolled over two years, and their surgical specimens will be analyzed for residual cancer burden. Additionally, the study will include a cohort of patients who meet the criteria but choose not to participate in the interventional group.

Why it matters

Potential benefit: If successful, this approach could enhance the effectiveness of neoadjuvant chemotherapy in achieving complete tumor response in Luminal B breast cancer patients.

How similar studies have gone: While this specific approach is novel, similar studies have explored the use of radiation therapy in conjunction with chemotherapy, showing promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, Italy
    Recruiting

Study contacts

  • Principal investigator: Alessio G Morganti, MD, PhD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Study coordinator: Alice Zamagni, MD
  • Email: alice.zamagni4@unibo.it
  • Phone: +39 0512143564

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.