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NCT Number: NCT05665920

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

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.

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Key information

Conditions

Malignant Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultra-hypofractionated whole breast radiotherapy

Radiation

Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Standard Radiation

Radiation

Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Primary outcomes

  1. Locoregional recurrence (LRR)

    Time frame: 10 years

    To estimate and compare the rate of local recurrence between the experimental and control arms.

Secondary outcomes

  1. Overall survival

    Time frame: 10 years

    Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.

  2. Disease-free survival

    Time frame: 10 years

    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.

  3. Locoregional control

    Time frame: 10 years

    Locoregional control defined as biopsy-proven recurrence of breast cancer involving the chest wall, breast, axilla, internal breast or supraclavicular nodes.

  4. Early and late adverse effects in normal tissues

    Time frame: 10 years

    To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.

  5. Late adverse effects

    Time frame: 10 years

    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.

  6. Acute toxicity rate

    Time frame: 10 years

    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).

  7. 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)

    Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 10 years after treatment end

    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.

  8. Measurement Satisfaction of Body Image of the participants

    Time frame: Baseline and 3 months, 6 months, 12 months after radiotherapy and 2 years, 10 years after treatment end

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alayne Yamada, PhD

CONTACT

[email protected]

+55114450-0347

Eduardo Barbieri

CONTACT

[email protected]

+551198639-1945

Sponsors and collaborators

Lead sponsor

Instituto Brasileiro de Controle do Cancer

Other

Registry information

Official study 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

Acronym: HYPHEN

Important dates

Study start
2022
Primary completion
2027
Study completion
2030
First posted
Dec 27, 2022
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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