Dose-escalated simultaneous boost whole-breast radiotherapy for early breast cancer
Official title: Hypofractionated Radiotherapy With Dose Escalated Concomitant Boost for Breast Cancer: a Phase 2 Trial
Run by Fondazione Policlinico Universitario Campus Bio-Medico · NCT07021846 · Data updated 2026-11-12
This trial will test a shorter course of whole-breast radiation with a higher simultaneous dose to the tumor bed for women 50 or younger with early breast cancer and extra recurrence risk factors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 132 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | March 12, 2020 |
| Main results expected | March 2026 |
| Study ends | March 2030 |
| Registry record updated | June 15, 2025 |
| Trial ID | NCT07021846 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18–50 after breast-conserving surgery with ≥3 surgical clips and at least one risk factor (N1 disease, lymphovascular invasion, extensive intraductal component >25%, close margins <4 mm, non-hormone-sensitive tumor, or grade 3).
✕Probably not a fit
Patients with prior chest irradiation, bilateral breast cancer, neoadjuvant chemotherapy, BMI >35, collagen disease, or those who are pregnant or breastfeeding are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-arm phase II trial testing a hypofractionated whole-breast schedule of 40.05 Gy in 15 fractions with a simultaneous integrated tumor-bed boost to 52.5 Gy (3.5 Gy/day). The study will enroll about 132 patients aged ≤50 who have undergone breast-conserving surgery and have at least one predefined risk factor for local recurrence. The primary endpoint is the rate of radiation-induced fibrosis at 4 years, with secondary endpoints including cosmetic outcome, quality of life, and local control. Each participant will have a minimum follow-up of four years at a single center in Rome.
Why it matters
Potential benefit: If successful, the approach could shorten treatment time while delivering a higher tumor-bed dose without increasing long-term fibrosis or poor cosmetic results.
How similar studies have gone: Hypofractionated whole-breast radiotherapy and tumor-bed boosts have shown acceptable toxicity and cosmetic results in prior studies, but high-dose simultaneous integrated boosts of this magnitude are less extensively tested in large prospective cohorts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically proven breast cancer who have undergone conservative surgery * at least 3 inserted clips * age: from 18 years old to 50 years * at least one of the following risk factors: N1 disease, LVI, extensive intraductal component (\>25%), close margins (\<4 mm), non-hormone-sensitive disease, grading 3 * ECOG performance status \< 2 * adequate bone marrow (haemoglobin concentration \> 8 g/dl, white blood cell count \> 3000/mm3, platelet count \> 75000). Exclusion Criteria: * Previous chest radiation treatment * Bilateral breast cancer * Neoadjuvant chemotherapy * BMI \> 35 * Collagen diseases * Pregnancy or breastfeeding
Where it's running
-
Università Campus Biomedico
Roma, Italy Recruiting
Study contacts
- Study coordinator: Edy Ippolito, Prof
- Email: e.ippolito@unicampus.it
- Phone: +3906225418081
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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.