Using radiation therapy before chemotherapy for Luminal B breast cancer
Immune and Pathological Response in Breast Cancer After Preoperative Irradiation With Stereotactic Technique and Neoadjuvant ChemOtherapy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bologna) |
| Trial ID | NCT05673304 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with clinical stage T1-2 Luminal B breast cancer who are indicated for neoadjuvant chemotherapy.
Not a fit: Patients who are pregnant, breastfeeding, or unable to attend follow-up appointments may not benefit from this study.
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 performed: While this specific approach is novel, similar studies have explored the use of radiation therapy in conjunction with chemotherapy, showing promising results.
Eligibility criteria
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 this trial is running
Bologna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.