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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | May 24, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | December 18, 2024 |
| Trial ID | NCT05673304 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
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.