About this trial
The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and/or regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.
Eligibility criteria
Qualifiers
Aged ≥18 years old
Karnofsky Performance Status (KPS) score ≥70
Histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician.
ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), and Ki67 testing must be performed on the primary breast tumor.
Disqualifiers
Pregnant or lactating women.
Severe non-neoplastic medical comorbidities that may interfere with treatment or study participation.
Active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity.
Patients with contraindications to undergoing IMPT or IMRT, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.
Trial design
Treatments tested in this trial
- Postoperative radiotherapy
- Preoperative Radiotherapy
- Definitive Radiotherapy
Treatment groups
Sponsors and collaborators
Ruijin Hospital
Lead sponsor
Shandong Cancer Hospital and Institute
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Collaborator
Tongji Hospital
Collaborator