Proton 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.
Photon radiotherapy: 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.
Study summary
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:
1. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery?
2. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Histologically confirmed invasive breast cancer.
2. Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left breast cancer:
1. Post lumpectomy: Patients who have undergone lumpectomy with postoperative pathology staged as pT1-3 N1-3, excluding N3c.
2. Post mastectomy: Patients who have undergone mastectomy, with postoperative pathology staged as pT1-3 N1-3, excluding N3c, and who have had an implant (prosthesis or tissue expander) placed.
3. Neoadjuvant therapy patients: Patients who have received neoadjuvant chemotherapy or endocrine/targeted therapy and have a postoperative stage of ypT1-3 N0-3, excluding N3c, requiring radiotherapy to the chest wall/breast and regional lymphatic drainage areas.
4. No distant metastasis.
5. Age range: 18-80 years.
6. Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0-2.
7. Non-pregnant and non-lactating women.
8. Informed consent: Patients must provide written informed consent prior to receiving radiotherapy.
Exclusion Criteria:
1. Presence of Ductal Carcinoma In Situ (DCIS).
2. Tumor staging: Patients presenting with T4, N0, or N3c disease.
3. History of prior radiotherapy to the ipsilateral chest or breast.
4. Surgical margin status: Margins are either positive or close, defined as:
Invasive carcinoma within 1 mm of the surgical margin.
5. Bilateral breast cancer: Patients with synchronous or previous contralateral breast cancer.
Primary outcome measure(s)
The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years — Until 2 years after radiotherapy 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.
Trial sites (1)
Facility
City
Region
Status
Shanghai Proton and Heavy Ion Center
Shanghai
China
Recruiting
More Shanghai Proton and Heavy Ion Center trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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