Accelerated radiotherapy with integrated boost for early breast cancer
A Prospective Phase II Trial of an Accelerated Hypofractionated Radiotherapy Schedule With Risk-adapted Simultaneous Integrated Boost (HF-SIB) in Early Breast Cancer Patients Undergoing Breast Conserving Surgery
This study is testing a new way of giving radiation therapy to women with early breast cancer after surgery to see if it helps them recover better and faster.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06224244 on ClinicalTrials.gov |
What this trial studies
This phase two trial evaluates the feasibility of a ten-fraction accelerated hypofractionated radiotherapy schedule with a simultaneous integrated boost for patients with early breast cancer who have undergone breast conserving surgery. Participants will receive whole breast irradiation along with a risk-adapted boost dose at the tumor bed based on clinical and pathological risk factors. The study aims to determine the effectiveness and safety of this treatment approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include female patients aged 18 and older with histologically proven unifocal breast adenocarcinoma who have undergone breast conserving surgery.
Not a fit: Patients who have undergone mastectomy or have a history of other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and less time-consuming treatment for early breast cancer patients.
How similar studies have performed: Other studies have shown promise with hypofractionated radiotherapy approaches, but this specific method with simultaneous integrated boost is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome, Lazio
- Regina Elena Cancer Institute — Rome, Lazio, Italy (Recruiting)
Study contacts
- Study coordinator: Silvia Takanen
- Email: silvia.takanen@ifo.it
- Phone: +39065266
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.