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Compares treatment options for Malignant Breast Neoplasm
Official title Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
ClinicalTrials.gov ID: NCT05665920
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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;
You likely can't join if
- 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...
- Diagnosis of autoimmune and connective tissue diseases;
- Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia);
See the full eligibility 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.