Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy

Malignant Breast Neoplasm Clinical Trial

— HYPHEN  

Official title:

Clinical Trial to Assess the Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665920
• Other study ID #: 60905722.0.0000.0072
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: December 31, 2030

Study information

• Verified date: December 2022
• Source: Instituto Brasileiro de Controle do Cancer
• Contact: Eduardo Barbieri
• Phone: +551198639-1945
• Email: edurxt[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, interventional, exploratory, controlled, randomized study in a 1:1 ratio, to be carried out in a single center, and seeks to evaluate the safety and efficacy of hypofractionated irradiation in women with breast cancer who receive nodal irradiation regional.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2030
• Est. primary completion date: October 18, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Malignant Breast Neoplasm

Intervention

Radiation:
• Ultra-hypofractionated whole breast radiotherapy
Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week
• Standard Radiation
Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Locations

Country	Name	City	State
Brazil	IBCC Oncologia	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Controle do Cancer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional recurrence (LRR)	To estimate and compare the rate of local recurrence between the experimental and control arms.	10 years
Secondary	Overall survival	Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.	10 years
Secondary	Disease-free survival	Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.	10 years
Secondary	Locoregional control	Locoregional control defined as biopsy-proven recurrence of breast cancer involving the chest wall, breast, axilla, internal breast or supraclavicular nodes.	10 years
Secondary	Early and late adverse effects in normal tissues	To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.	10 years
Secondary	Late adverse effects	To evaluate if the patient had symptoms of swelling or edema in the arm, breast shrinkage, hardness, pigmentation, necrosis, pain and tenderness in the breast.	10 years
Secondary	Acute toxicity rate	To evaluate acute toxicity rate. The maximum grade for acute toxicity will be recorded for each patient at each treatment evaluation using RTOG (Radiation Therapy Oncology Group).	10 years
Secondary	Evaluation of quality of life change by European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)	To evaluate the patient quality of life with the help of the European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.	Baseline and 3 months, 6 months, 12 months, 2 years, 10 years after treatment end
Secondary	Measurement Satisfaction of Body Image of the participants	To evaluate the patient quality of life and patient satisfaction with the help of the Body Image Scale (BIS). Scores are interpreted according to the guidelines of the Scoring Manual. The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment. The total score ranges from 0 to 30. A higher score means a higher level of body image disturbance.	Baseline and 3 months, 6 months, 12 months after radiotherapy and 2 years, 10 years after treatment end