NCT06660628 Large Segmentation Radiotherapy ± Deep Inspiration Breath Hold(DIBH) for Left Breast Cancer
| NCT ID | NCT06660628 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 348 participants |
| Start Date | 2024-08-21 |
| Primary Completion | 2029-08-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 348 participants in total. It began in 2024-08-21 with a primary completion date of 2029-08-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: 1. 18-70 years old, female, life expectancy \> 5 years 2. ECOG 0, 1, 2 points 3. Pathologically diagnosed with left breast cancer and underwent breast-conserving surgery or modified radical mastectomy 4. 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. 5. No prior neoadjuvant chemotherapy or breast reconstruction. 6. No active cardiac disease, myocardial infarction, or congestive cardiac failure at baseline. 7. Patients can hold their breath for at least 30 seconds after training 8. Patients who can be followed up and agree to follow the plan. 9. Sign the consent form. Exclusion Criteria: 1. Lesions were observed on both sides of the breast. 2. Diagnosis could not be confirmed by pathology. 3. Distant metastasis was identified. 4. The patient had undergone neoadjuvant chemotherapy or breast reconstruction surgery. 5. Severe cardiac insufficiency; myocardial infarction or uncorrected unstable cardiac arrhythmia or uncorrected unstable angina within the last 3 months; or pericardial disorders 6. The patient's New York Heart Association (NYHA) cardiac classification is within categories 2-4. 7. A history of chronic lung disease, including conditions that may contribute to ductal dilatation, such as chronic obstructive pulmonary disease (COPD) and interstitial pneumonia. 8. Previous mediastinal radiotherapy. 9. 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). 10. Irradiation of the lymphatic drainage area of the internal breast is required.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06660628 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06660628 currently recruiting?
Yes, NCT06660628 is actively recruiting participants. Contact the research team at hxr_pumch@163.com for enrollment information.
Where is the NCT06660628 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06660628 clinical trial?
NCT06660628 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 348 participants.
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