A Phase 1 interventional study of proton plus carbon ion radiotherapy in Triple Negative Breast Cancer and HER2-positive Breast Cancer, sponsored by Shanghai Proton and Heavy Ion Center. Recruiting at 1 site in China. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by Shanghai Proton and Heavy Ion Center · Phase 1, Interventional, and Treatment
Adjuvant radiotherapy is the standard treatment for early breast cancer after breast conserving surgery. Molecular subtypes was significantly associated with the risk of local recurrence of breast cancer. Nguyen et al found that the overall 5-year cumulative incidence of local recurrence was 0.8% for luminal A, 1.5% for luminal B, 8.4% for HER2 positive, and 7.1% for triple negative breast cancer after lumpectomy and radiotherapy. Her2 positive and triple negative breast cancers may be inherently radioresistant.
Therefore, for HER2 positive and triple negative breast cancer with high local recurrence and radiation resistance, proton combined with carbon ion is proposed after breast conserving surgery.
Exclusion Criteria:
CTV1: whole breast, proton therapy. CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels.
Radiation: proton plus carbon ion radiotherapy
CTV1: whole breast, 40.05Gy(RBE) in 15 fractions with proton ion therapy; CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels \[10.2Gy(RBE)/3Fx,10.8Gy(RBE) /3Fx,11.4Gy(RBE)/3Fx and 12Gy(RBE)/3Fx \].
Acute toxicity
Treatment related acute toxicity assessed by CTCAE v4.03
Time frame: 3 months after the completion of CIRT
Local regional recurrence
The Ipsilateral breast and regional lymph nodes recurrence
Time frame: within 5 years after radiotherapy.
Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale
Cosmetic outcome will be evaluated by Breast Cancer Treatment Outcomes Scale filled out by patients.
Time frame: within 5 years after radiotherapy.
Cosmetic outcome as measured by BCCT.core software
Patients' photographs of the breasts will be taken. With the use of BCCT.core software from The Breast Research group (INESC TEC) cosmetic outcome will be assessed.
Time frame: within 5 years after radiotherapy.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Shanghai Proton and Heavy Ion Center