Adjuvant proton radiotherapy for breast cancer after reconstruction
A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
PHASE2 · Shanghai Proton and Heavy Ion Center · NCT05692674
This study tests a new type of targeted radiation therapy for breast cancer patients who have had reconstruction surgery to see if it can reduce damage to the heart and lungs while still effectively treating their cancer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Shanghai Proton and Heavy Ion Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05692674 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 80 with pathologically confirmed breast cancer who require adjuvant radiotherapy after mastectomy and implant reconstruction.
Not a fit: Patients with distant metastasis, prior chest or breast radiotherapy, or significant health complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for breast cancer patients undergoing reconstruction by minimizing radiation-related complications.
How similar studies have performed: While there is limited data on proton therapy for this specific indication, similar approaches in radiation therapy have shown promise in reducing side effects and improving outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai Proton and Heavy Ion center — Shanghai, Shanghai Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, breast cancer, hypofractionated, proton radiotherapy, implantation reconstruction, postoperative adjuvant radiotherapy