Adjuvant proton radiotherapy for breast cancer after reconstruction

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 study investigates the use of adjuvant hypofractionated intensity-modulated proton radiotherapy for patients with post-operative breast cancer who have undergone implantation reconstruction. The goal is to reduce the radiation exposure to the heart and lungs, potentially lowering the risk of cardiac events and radiation pneumonia. By focusing on this specific patient population, the study aims to provide a safer and more effective treatment option that does not compromise the success of breast reconstruction. Participants will receive proton therapy following their mastectomy and reconstruction surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1: Patients with pathologically confirmed breast cancer

  2: Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction

  3: No distant metastasis

  4: Had no chest and breast radiotherapy history

  5: Between the ages of 18 and 80

  6: ECOG general status score is 0-2,There are no serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease and other complications that may affect the radiotherapy

  7: Non pregnancy (confirmed by serum or urine β- HCG test) or lactating women

  8: The patient must sign the informed consent form for receiving radiotherapy.

Exclusion Criteria:

* 1: No pathological confirmation；

  2: Distant metastasis；

  3: Had chest and breast radiotherapy history

  4: Organs at risk could not achieve safe dose

  5: Pregnancy (confirmed by serum or urine β- HCG test) or lactating women

  6: Poor general health status, i.e. KPS\<70, or ECOG\>2

  7: There are serious complications that may affect the radiotherapy, including: a) unstable angina, congestive heart failure and myocardial infarction requiring hospitalization in the past 6 months； b) Acute bacterial or systemic fungal infection；c) Chronic obstructive pulmonary disease exacerbation or other respiratory diseases need hospitalization； d) Patients with immunosuppression；e) With connective tissue disease, such as active scleroderma or lupus and other contraindications to radiotherapy；

  8: Unable to understand the purpose of treatment or unwilling/unable to sign informed consent.

Where it's running

• Shanghai Proton and Heavy Ion center
  Shanghai, Shanghai Municipality, China Recruiting

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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.