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Active, not recruiting Phase 2

External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients

NCT06224244 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2022-02-01
Last updated
2025-07-25

Condition(s) studied

Breast NeoplasmsBreast Cancer

Investigational drug(s) / intervention(s)

Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boostTen-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost

Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost: Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy

Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost: Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy

Study summary

This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Histologically proven invasive or in situ unifocal adenocarcinoma of the breast * Breast conserving surgery * Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells \[i+\] allowed) pN1mic, M0 stage * Postoperative negative (no ink) final surgical margins * Patient requires a whole breast radiotherapy plus a tumor bed boost * Female patients aged ≥ 18 years of any menopausal status * ECOG performance status 0-2 Exclusion Criteria: * Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free * Mastectomy * Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded) * Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma * Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder * Pregnant or lactating patients * Presence of ipsilateral breast implant * Prior breast or thoracic radiotherapy for any condition

Primary outcome measure(s)

  • Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale — From the end of treatment at 3 years
    Incidence of grade 2-3 late toxicity in terms of skin toxicity

Trial sites (1)

FacilityCityRegionStatus
Regina Elena Cancer Institute Rome Lazio
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06224244 on ClinicalTrials.gov ↗ ← All trials in Italy