Deep inspiration breath-hold planning for internal mammary radiation after breast cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, prospective observational project follows postoperative breast cancer patients planned for regional nodal radiotherapy including the internal mammary nodes under DIBH. Participants are treated with contemporary techniques (IMRT/VMAT and potentially proton therapy) while using surface guidance and imaging to monitor breath-hold and positional variation. The study compares robustness of plans using 1.5 mm, 2 mm, and 3 mm gating windows and quantifies intrafractional and interfractional positional errors. Primary analyses focus on actual target dose coverage and organ-at-risk dose parameters (heart, lung) to determine whether they remain within clinically acceptable ranges during treatment delivery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures.
2. Female patients aged ≥ 18 years.
3. Histologically confirmed invasive breast cancer.
4. Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy and/or axillary lymph node dissection.
5. Able to hold breath for more than 30 seconds after deep inspiration.
6. Planned to receive postoperative radiotherapy targeting regional lymph nodes, including the internal mammary nodes, under DIBH conditions.
7. Planned to undergo moderate hypofractionated radiotherapy.
8. Karnofsky Performance Status (KPS) score ≥ 80.
9. The estimated life expectancy of greater than 5 years .
10. Sufficient wound healing from surgery, with no signs of active infection at the intended radiation site.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Presence of any severe, uncontrolled comorbidity or medical condition that, in the investigator's judgment, would render the participant unsuitable for the study, compromise protocol compliance, or confound the interpretation of study results.
3. Unable to understand or comply with breath-hold training instructions.
4. Right-sided breast cancer.

Where it's running

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Lu Cao, PhD
• Email: cl11879@rjh.com.cn
• Phone: +86-021-64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.