Back to resultsEfficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy (HYPHEN)
Primary Purpose
Malignant Breast Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ultra-hypofractionated whole breast radiotherapy
Standard Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Breast Neoplasm focused on measuring Dose splitting, Acute and late toxicity, Locoregional drainage irradiation, Breast neoplasm, Overall survival, Disease-free survival, Locoregional control
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.
Sites / Locations
- IBCC OncologiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Whole breast Radiotherapy
Ultra-hypofractionated whole breast radiotherapy
Arm Description
Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage
Ultra-hypofractionated radiation: Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week
Outcomes
Primary Outcome Measures
Locoregional recurrence (LRR)
To estimate and compare the rate of local recurrence between the experimental and control arms.
Secondary Outcome Measures
Overall survival
Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.
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.
Locoregional control
Locoregional control defined as biopsy-proven recurrence of breast cancer involving the chest wall, breast, axilla, internal breast or supraclavicular nodes.
Early and late adverse effects in normal tissues
To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
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.
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).
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.
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.
Full Information
NCT ID
NCT05665920
First Posted
December 16, 2022
Last Updated
December 26, 2022
Sponsor
Instituto Brasileiro de Controle do Cancer
1. Study Identification
Unique Protocol Identification Number
NCT05665920
Brief Title
Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
October 18, 2027 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Brasileiro de Controle do Cancer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Breast Neoplasm
Keywords
Dose splitting, Acute and late toxicity, Locoregional drainage irradiation, Breast neoplasm, Overall survival, Disease-free survival, Locoregional control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Whole breast Radiotherapy
Arm Type
Active Comparator
Arm Description
Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage
Arm Title
Ultra-hypofractionated whole breast radiotherapy
Arm Type
Experimental
Arm Description
Ultra-hypofractionated radiation: Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week
Intervention Type
Radiation
Intervention Name(s)
Ultra-hypofractionated whole breast radiotherapy
Intervention Description
Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week
Intervention Type
Radiation
Intervention Name(s)
Standard Radiation
Intervention Description
Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage
Primary Outcome Measure Information:
Title
Locoregional recurrence (LRR)
Description
To estimate and compare the rate of local recurrence between the experimental and control arms.
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.
Time Frame
10 years
Title
Disease-free survival
Description
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.
Time Frame
10 years
Title
Locoregional control
Description
Locoregional control defined as biopsy-proven recurrence of breast cancer involving the chest wall, breast, axilla, internal breast or supraclavicular nodes.
Time Frame
10 years
Title
Early and late adverse effects in normal tissues
Description
To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
Time Frame
10 years
Title
Late adverse effects
Description
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.
Time Frame
10 years
Title
Acute toxicity rate
Description
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).
Time Frame
10 years
Title
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)
Description
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.
Time Frame
Baseline and 3 months, 6 months, 12 months, 2 years, 10 years after treatment end
Title
Measurement Satisfaction of Body Image of the participants
Description
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.
Time Frame
Baseline and 3 months, 6 months, 12 months after radiotherapy and 2 years, 10 years after treatment end
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Barbieri
Phone
+551198639-1945
Email
edurxt@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alayne Yamada, PhD
Phone
+55114450-0347
Email
alayne.yamada@hospitalsaocamilosp.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Barbieri
Organizational Affiliation
IBCC Oncologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
IBCC Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
03102-002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Barbieri
Phone
+55 11 98639-1945
Email
edurxt@gmail.com
First Name & Middle Initial & Last Name & Degree
Alayne Yamada, PhD
Phone
+55114450-0347
Email
alayne.yamada@hospitalsaocamilosp.org.br
First Name & Middle Initial & Last Name & Degree
Eduardo Barbieri
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
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