NCT07021846 Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer
| NCT ID | NCT07021846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2020-03-12 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2020-03-12 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this prospective, single-arm, phase II, non-randomized trial is to evaluate an hypofractionation schedule with high dose simultaneous integrated tumor bed boost in early breast cancer patients. The main question\[s\] it aims to answer are: * evaluate the rate of all grades of radiation-induced fibrosis at 4 years. * evaluate poor/fair cosmesis rate Participants will be treated with hypofractionated radiotherapy (RT) to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die)
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07021846 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07021846 currently recruiting?
Yes, NCT07021846 is actively recruiting participants. Contact the research team at e.ippolito@unicampus.it for enrollment information.
Where is the NCT07021846 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07021846 clinical trial?
NCT07021846 is sponsored by Fondazione Policlinico Universitario Campus Bio-Medico. The trial plans to enroll 132 participants.
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