Malignant Breast NeoplasmHYPHENNCT05665920
Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
A study testing Ultra-hypofractionated whole breast radiotherapy and Standard Radiation in people with Malignant Breast Neoplasm, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Breast Neoplasm
- What is being tested?
- Ultra-hypofractionated whole breast radiotherapy and Standard Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Oct 2022to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
IBCC Oncologia
São Paulo, São Paulo, 03102-002
Eduardo Barbieri, +55 11 98639-1945, edurxt@gmail.com
Alayne Yamada, PhD, +55114450-0347, alayne.yamada@hospitalsaocamilosp.org.br
About this study
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
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.
Read the 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.
- Conditions
- Malignant Breast Neoplasm
- Being tested
- Ultra-hypofractionated whole breast radiotherapy, Standard Radiation
- Keywords
- Dose splitting, Acute and late toxicity, Locoregional drainage irradiation, Breast neoplasm, Overall survival, Disease-free survival, Locoregional control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-hypofractionated whole breast radiotherapyRadiation
Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week
Standard RadiationRadiation
Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage
| Study group | Role | What they receive |
|---|---|---|
| Standard Whole breast Radiotherapy | Active comparator | Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage Receives: Radiation: Standard Radiation |
| Ultra-hypofractionated whole breast radiotherapy | Experimental | Ultra-hypofractionated radiation: Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week Receives: Radiation: Ultra-hypofractionated whole breast radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional recurrence (LRR)
To estimate and compare the rate of local recurrence between the experimental and control arms.
Measured: 10 years
Secondary outcomes (8)
Overall survival
Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.
Measured: 10 years
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.
Measured: 10 years
Locoregional control
Locoregional control defined as biopsy-proven recurrence of breast cancer involving the chest wall, breast, axilla, internal breast or supraclavicular nodes.
Measured: 10 years
Early and late adverse effects in normal tissues
To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
Measured: 10 years
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.
Measured: 10 years
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).
Measured: 10 years
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.
Measured: Baseline and 3 months, 6 months, 12 months, 2 years, 10 years after treatment end
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.
Measured: Baseline and 3 months, 6 months, 12 months after radiotherapy and 2 years, 10 years after treatment end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start18 Oct 2022
- Primary completion18 Oct 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Brasileiro de Controle do Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Barbieri, Instituto Brasileiro de Controle do Cancer
- Investigators
- Eduardo Barbieri, Principal investigator, IBCC Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665920
- Sponsor's protocol ID
- 60905722.0.0000.0072
- Acronym
- HYPHEN
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05665920
- Acronym / sponsor ID
- HYPHEN / 60905722.0.0000.0072
- Conditions
- Malignant Breast Neoplasm
- Keywords
- Dose splitting, Acute and late toxicity, Locoregional drainage irradiation, Breast neoplasm, Overall survival, Disease-free survival, Locoregional control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Instituto Brasileiro de Controle do CancerUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 18 Oct 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Whole breast Radiotherapy | Active comparator | Radiation: Standard RadiationStandard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage |
| Ultra-hypofractionated whole breast radiotherapy | Experimental | Radiation: Ultra-hypofractionated whole breast radiotherapyUltra-hypofractionated radiation: Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-hypofractionated whole breast radiotherapyUltra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week | Radiation | Ultra-hypofractionated whole breast radiotherapy |
| Standard RadiationStandard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage | Radiation | Standard Whole breast Radiotherapy |
Primary outcome
Locoregional recurrence (LRR)
Time frame: 10 years
To estimate and compare the rate of local recurrence between the experimental and control arms.
8 secondary outcomes
Overall survival
Time frame: 10 years
Disease-free survival
Time frame: 10 years
Locoregional control
Time frame: 10 years
Early and late adverse effects in normal tissues
Time frame: 10 years
Late adverse effects
Time frame: 10 years
Acute toxicity rate
Time frame: 10 years
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eduardo Barbieri principal investigator
IBCC Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-hypofractionated whole breast radiotherapy and Standard Radiation in people with Malignant Breast Neoplasm, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Barbieri (+551198639-1945, edurxt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional recurrence (LRR) (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.