Breast CancerNCT05200078
Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer
An observational study of Breast Cancer and Cardiac Event, run by Shu lian Wang at 1 site in China.
Trial summary
Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Cardiac Event
- What is being tested?
- Deep inspiration breath-hold technique
- Type of treatment
- Medical device
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: women with left-sided breast cancer planning for adjuvant radiotherapy
Who may be able to join
- Primary left-sided breast cancer post surgery
- Planning for adjuvant breast/chest wall +-RNI
Who cannot join
- History of cardiovascular disease
- Previous chest radiation
- Bilateral breast cancers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Shu-Lian Wang, 8610-87787659, wangsl@cicams.ac.cn
Shu-lian Wang, M.D
About this study
Official title: Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer in Reducing Early Cardiac Injury: a Phase II Prospective Study
Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. This study aims to prospectively detect and predict early clinical or subclinical cardiac events in women undergoing adjuvant RT for breast cancer.
Read the detailed description
Women with left-sided breast cancer undergo hypofractionated RT at either free-breathing or deep inspiration breath-hold. The incidence and potential clinical, dosimetric and biological indicators of early clinical or subclinical cardiac injury are investigate at 2 years.
- Conditions
- Breast Cancer, Cardiac Event
- Being tested
- Deep inspiration breath-hold technique
- Medical subject headings
- Breast Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep inspiration breath-hold techniqueDevice
Selective application of deep inspiration breath-hold technique
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy at free-breathing | breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at free-breathing | |
| Radiotherapy at deep inspiration breath-hold | breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at deep inspiration breath-hold Receives: Device: Deep inspiration breath-hold technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical or subclinical cardiac injury
predefined cardiac events
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Sep 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shu lian Wang
- Responsible party
- Sponsor-investigator, Shu lian Wang, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200078
- Sponsor's protocol ID
- 2020-2-4023
- Status last verified
- Jan 2022
- First submitted
- 13 Dec 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer in Reducing Early Cardiac Injury: a Phase II Prospective Study
- ClinicalTrials.gov ID
- NCT05200078
- Acronym / sponsor ID
- 2020-2-4023
- Conditions
- Breast Cancer, Cardiac Event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Shu lian Wang
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 20 Jan 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.
Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. This study aims to prospectively detect and predict early clinical or subclinical cardiac events in women undergoing adjuvant RT for breast cancer.
Detailed description
Women with left-sided breast cancer undergo hypofractionated RT at either free-breathing or deep inspiration breath-hold. The incidence and potential clinical, dosimetric and biological indicators of early clinical or subclinical cardiac injury are investigate at 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy at free-breathing | – | –breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at free-breathing |
| Radiotherapy at deep inspiration breath-hold | – | Device: Deep inspiration breath-hold techniquebreast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at deep inspiration breath-hold |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- women with left-sided breast cancer planning for adjuvant radiotherapy
Key inclusion criteria (2 listed)
- Primary left-sided breast cancer post surgery
- Planning for adjuvant breast/chest wall +-RNI
Key exclusion criteria (3 listed)
- History of cardiovascular disease
- Previous chest radiation
- Bilateral breast cancers
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 |
|---|---|---|
| Deep inspiration breath-hold techniqueSelective application of deep inspiration breath-hold technique | Device | Radiotherapy at deep inspiration breath-hold |
Primary outcome
Incidence of clinical or subclinical cardiac injury
Time frame: two years
predefined cardiac events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cardiac Event, run by Shu lian Wang 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jan 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Lian Wang (86-13366191993, wangsl@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical or subclinical cardiac injury (time frame: two 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 20 Jan 2022.