Breast CancerDLLEBNCT06660628
Large Segmentation Radiotherapy ± Deep Inspiration Breath Hold(DIBH) for Left Breast Cancer
A study testing Large Segmentation Radiotherapy, DIBH and Surface guided radiation therapy in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The study is a single-center, prospective, non-randomized controlled study. The primary objective is to examine the clinical outcomes of utilizing Deep Inspiration Breath Hold (DIBH) in conjunction with hypo-fractionated radiotherapy for patients diagnosed with left-sided breast cancer with a particular focus on its… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Large Segmentation Radiotherapy, DIBH and Surface guided radiation therapy
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2024to 21 Aug 2034
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old, female, life expectancy > 5 years
- ECOG 0, 1, 2 points
- Pathologically diagnosed with left breast cancer and underwent breast-conserving surgery or modified radical mastectomy
- The patient will receive radiation therapy to the entire breast or chest wall ± the lymphatic drainage area above and below the clavicle ± the lymphatic drainage area in the axilla.
- No prior neoadjuvant chemotherapy or breast reconstruction.
- No active cardiac disease, myocardial infarction, or congestive cardiac failure at baseline.
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- Patients can hold their breath for at least 30 seconds after training
- Patients who can be followed up and agree to follow the plan.
- Sign the consent form.
Who cannot join
- Lesions were observed on both sides of the breast.
- Diagnosis could not be confirmed by pathology.
- Distant metastasis was identified.
- The patient had undergone neoadjuvant chemotherapy or breast reconstruction surgery.
- Severe cardiac insufficiency; myocardial infarction or uncorrected unstable cardiac arrhythmia or uncorrected unstable angina within the last 3 months; or pericardial disorders
- The patient's New York Heart Association (NYHA) cardiac classification is within categories 2-4.
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- A history of chronic lung disease, including conditions that may contribute to ductal dilatation, such as chronic obstructive pulmonary disease (COPD) and interstitial pneumonia.
- Previous mediastinal radiotherapy.
- Previous or concurrent second primary malignant tumor (except skin cancer that is not a malignant black pigmented tumor, papillary/follicular carcinoma of the thyroid, carcinoma in situ of the cervix, and contralateral non-invasive breast cancer).
- Irradiation of the lymphatic drainage area of the internal breast is required.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiaorong Hou, +86 13811963013, hxr_pumch@163.com
About this study
Official title: Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold for Left Sided Breast Cancer, A Real-World Study
The study is a single-center, prospective, non-randomized controlled study. The primary objective is to examine the clinical outcomes of utilizing Deep Inspiration Breath Hold (DIBH) in conjunction with hypo-fractionated radiotherapy for patients diagnosed with left-sided breast cancer with a particular focus on its potential to reduce the incidence of cardiac-related clinical and subclinical events.Participants will revieve large segmentation sadiotherapy ± DIBH for left breast cancer and be followed up to gather their clinical cardiac imformation.
- Conditions
- Breast Cancer
- Being tested
- Large Segmentation Radiotherapy, DIBH, Surface guided radiation therapy, laser alignment, free breathing
- Keywords
- breast cancer, heart toxicity, DIBH, dose prediction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Segmentation RadiotherapyRadiation
Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold
DIBHDevice
Deep Inspiration Breath Hold
Surface guided radiation therapyDevice
The technology uses modern 3D camera technology to help track and monitor patient movements during set-up and treatment.
laser alignmentDevice
Laser systems for virtual simulation and patient positioning in radiotherapy
free breathingBehavioural
Patients breathe calmly while radiotherapy instead of holding their breath.
| Study group | Role | What they receive |
|---|---|---|
| Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique | Experimental | Patients with left breast cancer treated with Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique Receives: Radiation: Large Segmentation Radiotherapy; Device: DIBH; Device: Surface guided radiation therapy |
| laser alignment combined with free breathing treatment | Active comparator | Patients with left breast cancer treated with traditional laser alignment with free breathing treatment Receives: Radiation: Large Segmentation Radiotherapy; Device: laser alignment; Behavioral: free breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subclinical and clinical cardiac events
- Clinical events: newly emerged cardiac diseases after radiotherapy include acute and delayed pericarditis, pericardial effusion and constrictive pericarditis, coronary artery disease, myocardial infarction, cardiac valve disease and arrhythmia.
- Subclinical events: new electrocardiogram (ECG) abnormalities, echocardiographic abnormalities, and abnormal elevations of cardiac enzymes after radiotherapy.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Survival
Localized regional control rate ,overall survival and disease-related survival.
Measured: through study completion, an average of 1 year
Cosmetic results
cosmetic evaluation(breast-conserving surgery). Excellent: The treated mammary gland is indistinguishable or only slightly different in size, shape, and texture from the contralateral mammary gland. There may be mild thickening of the breast or skin, or scar tissue, but not enough to change the appearance of the colored gland.
Good: The treated breast is not mildly asymmetric in size or shape compared to the contralateral breast. Thickening or scar tissue in the breast causes only Fair: The treated breast is significantly different in size and shape from the contralateral breast. Such changes involving 1/4 or less of the treated breast are significantly different in appearance from the contralateral breast. The change involves more than 1/4 of the breast tissue.
Poor: The treated breast is significantly different in appearance from the contralateral breast. The change involves more than 1/4 of the breast tissue or the treated breast has severe sequelae.
Measured: through study completion, an average of 1 year
Life quality
Assessment of patient quality of life by EORTC QLQ-BR23 , a higher score means worse life quality.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start21 Aug 2024
- Primary completion21 Aug 2029 (estimated)
- Study completion21 Aug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660628
- Sponsor's protocol ID
- K6433
- Other IDs
- 2022-PUMCH-B-116
- Acronym
- DLLEB
- Status last verified
- Sep 2024
- First submitted
- 22 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold for Left Sided Breast Cancer, A Real-World Study
- ClinicalTrials.gov ID
- NCT06660628
- Acronym / sponsor ID
- DLLEB / K6433
- Conditions
- Breast Cancer
- Keywords
- breast cancer, heart toxicity, DIBH, dose prediction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 21 Aug 2029 (estimated)
- Study completion
- 21 Aug 2034 (estimated)
- First posted
- 28 Oct 2024 (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 study is a single-center, prospective, non-randomized controlled study. The primary objective is to examine the clinical outcomes of utilizing Deep Inspiration Breath Hold (DIBH) in conjunction with hypo-fractionated radiotherapy for patients diagnosed with left-sided breast cancer with a particular focus on its potential to reduce the incidence of cardiac-related clinical and subclinical events.Participants will revieve large segmentation sadiotherapy ± DIBH for left breast cancer and be followed up to gather their clinical cardiac imformation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique | Experimental | Radiation: Large Segmentation Radiotherapy, Device: DIBH, Device: Surface guided radiation therapyPatients with left breast cancer treated with Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique |
| laser alignment combined with free breathing treatment | Active comparator | Radiation: Large Segmentation Radiotherapy, Device: laser alignment, Behavioral: free breathingPatients with left breast cancer treated with traditional laser alignment with free breathing treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-70 years old, female, life expectancy > 5 years
- ECOG 0, 1, 2 points
- Pathologically diagnosed with left breast cancer and underwent breast-conserving surgery or modified radical mastectomy
- The patient will receive radiation therapy to the entire breast or chest wall ± the lymphatic drainage area above and below the clavicle ± the lymphatic drainage area in the axilla.
- No prior neoadjuvant chemotherapy or breast reconstruction.
Key exclusion criteria (10 listed)
- Lesions were observed on both sides of the breast.
- Diagnosis could not be confirmed by pathology.
- Distant metastasis was identified.
- The patient had undergone neoadjuvant chemotherapy or breast reconstruction surgery.
- Severe cardiac insufficiency; myocardial infarction or uncorrected unstable cardiac arrhythmia or uncorrected unstable angina within the last 3 months; or pericardial disorders
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 |
|---|---|---|
| Large Segmentation RadiotherapyLarge Segmentation Radiotherapy±Deep Inspiratory Breath Hold | Radiation | Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique, laser alignment combined with free breathing treatment |
| DIBHDeep Inspiration Breath Hold | Device | Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique |
| Surface guided radiation therapyThe technology uses modern 3D camera technology to help track and monitor patient movements during set-up and treatment. | Device | Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique |
| laser alignmentLaser systems for virtual simulation and patient positioning in radiotherapy | Device | laser alignment combined with free breathing treatment |
| free breathingPatients breathe calmly while radiotherapy instead of holding their breath. | Behavioural | laser alignment combined with free breathing treatment |
Primary outcome
Incidence of subclinical and clinical cardiac events
Time frame: through study completion, an average of 1 year
1. Clinical events: newly emerged cardiac diseases after radiotherapy include acute and delayed pericarditis, pericardial effusion and constrictive pericarditis, coronary artery disease, myocardial infarction, cardiac valve disease and arrhythmia. 2. Subclinical events: new electrocardiogram (ECG) abnormalities, echocardiographic abnormalities, and abnormal elevations of cardiac enzymes after radiotherapy.
3 secondary outcomes
Survival
Time frame: through study completion, an average of 1 year
Cosmetic results
Time frame: through study completion, an average of 1 year
Life quality
Time frame: through study completion, an average of 1 year
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 28 Oct 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large Segmentation Radiotherapy, DIBH and Surface guided radiation therapy in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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 9 inclusion and 10 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 28 Oct 2024. 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 China. 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 Xiaorong Hou (+86 13811963013, hxr_pumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of subclinical and clinical cardiac events (time frame: through study completion, an average of 1 year). 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 28 Oct 2024.