NCT05665920 Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
| NCT ID | NCT05665920 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Brasileiro de Controle do Cancer |
| Condition | Malignant Breast Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-10-18 |
| Primary Completion | 2027-10-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 36 participants in total. It began in 2022-10-18 with a primary completion date of 2027-10-18.
⚠ 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 reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. Thus, as a reference Institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 Gy / 5 fractions in one week, in a controlled manner, through this project.The investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.
Eligibility Criteria
Inclusion Criteria: * Information to the patient and signed informed consent; * Women aged ≥18 years; * Breast conserving surgery; * Invasive adenocarcinoma (except classic invasive lobular carcinoma); * TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol; * Eastern Cooperative Oncology Group (ECOG) 0 -1; * Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia); * No previous breast or mediastinal radiotherapy; * No hematogenous metastases; * Ability to carry out long-term follow-up; Exclusion Criteria: * Previous local irradiation; * Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed; * Histology of metaplastic carcinoma; * History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed. * Diagnosis of autoimmune and connective tissue diseases; * Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia); * Indication of internal breast irradiation.
Contact & Investigator
Eduardo Barbieri
PRINCIPAL INVESTIGATOR
IBCC Oncologia
Frequently Asked Questions
Who can join the NCT05665920 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Malignant Breast Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05665920 currently recruiting?
Yes, NCT05665920 is actively recruiting participants. Contact the research team at edurxt@gmail.com for enrollment information.
Where is the NCT05665920 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT05665920 clinical trial?
NCT05665920 is sponsored by Instituto Brasileiro de Controle do Cancer. The principal investigator is Eduardo Barbieri at IBCC Oncologia. The trial plans to enroll 36 participants.