Using Deep Inspiration Breath Hold with Radiotherapy for Left Breast Cancer

Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold for Left Sided Breast Cancer, A Real-World Study

This study is testing if using a special breathing technique during radiation therapy can help women with left breast cancer have fewer heart problems while getting treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 348 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06660628 on ClinicalTrials.gov

What this trial studies

This study investigates the clinical outcomes of combining Deep Inspiration Breath Hold (DIBH) with hypo-fractionated radiotherapy in patients with left-sided breast cancer. It aims to assess the potential of this approach to reduce cardiac-related events during treatment. Participants will receive large segmentation radiotherapy with or without DIBH and will be monitored for cardiac health over time. The study is non-randomized and conducted at a single center, focusing on a specific patient population.

Who should consider this trial

Good fit: Ideal candidates are females aged 18-70 with left breast cancer who have undergone surgery and can comply with the study's requirements.

Not a fit: Patients with bilateral breast lesions, distant metastasis, or those who have undergone neoadjuvant chemotherapy or breast reconstruction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce heart toxicity in patients undergoing treatment for left breast cancer.

How similar studies have performed: While the use of DIBH in radiotherapy is gaining attention, this specific combination with hypo-fractionated radiotherapy for left breast cancer is relatively novel.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaorong Hou

Conditions Breast Cancer; breast cancer; heart toxicity; DIBH; dose prediction