A Phase 2 interventional study of Proton radiotherapy and Photon radiotherapy in 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 2025-05-30.
Sponsored by Shanghai Proton and Heavy Ion Center · Phase 2, Interventional, and Treatment
The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are:
Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left breast cancer:
Exclusion Criteria:
Surgical margin status: Margins are either positive or close, defined as:
Invasive carcinoma within 1 mm of the surgical margin.
Proton radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer.
Radiation: Proton radiotherapy
Photon radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer.
Radiation: Photon radiotherapy
Lumpectomy group: The total dose was 40.05Gy (RBE) , 2.67Gy (RBE) per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy (RBE) , 2.66Gy (RBE) per fraction with 16 fractions. Once a day, five times a week.
Lumpectomy group: The total dose was 40.05Gy, 2.67Gy per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy, 2.66Gy per fraction with 16 fractions. Once a day, five times a week.
The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years
We will record the incidence of ≥ 2 degree radiation-associated toxicity, such as breast or chest wall oedema, dermatitis, breast pain, esophagitis, rib fracture, radiation pneumonia and hypothyroidism and so on. The incidence of all the above is the primary outcome.
Time frame: Until 2 years after radiotherapy
Late toxicities after 2 years of radiotherapy
Evaluation of long-term adverse effects (greater than 2 years) after radiotherapy (including radiation pulmonary fibrosis, radiation skin fibrosis, rib fracture, brachial plexus injury, upper limb lymphedema, heart injury, hypothyroidism, etc.)
Time frame: Until 5 years after radiotherapy
Locoregional recurrence (LRR)
To estimate and compare the rate of local recurrence between the proton and photon arms
Time frame: Until 5 years after treatment.
Disease-free survival (DFS)
Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.
Time frame: Until 5 years after treatment.
Overall survival (OS)
Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.
Time frame: Until 5 years after treatment.
uality of life, as measured by EORTC Quality of Life Questionnaires-B23
Impact on quality of life will be assessed by EORTC Quality of Life Questionnaires-B23；Which include functional domains, global health status and symptom scales.
Time frame: During last week of radiotherapy, at 3 months post radiotherapy and 1,3 and 5 years post radiotherapy
Cosmetic outcome
photographic cosmetic scores by BCCT.core
Time frame: Until 5 years after treatment.
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Shanghai Proton and Heavy Ion Center