Safety and Efficacy of IMPT or IMRT for Breast Cancer

Launched by RUIJIN HOSPITAL · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two types of radiation therapy for breast cancer: intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT). The goal is to see which treatment is safer and more effective for patients needing radiation before or after surgery, or as a main treatment. Patients will receive treatment to the entire breast, chest wall, and sometimes nearby lymph nodes. They will be monitored for at least five years to check for any side effects from the radiation, whether the cancer comes back, overall survival rates, and how treatment affects their quality of life.

To join this trial, participants need to be at least 18 years old and have a confirmed diagnosis of breast cancer. They should be in good enough health to participate and agree to use contraception if they could become pregnant. However, pregnant or nursing women, those with certain serious health conditions, or individuals who cannot tolerate the treatment methods cannot take part. Participants in the trial can expect close follow-up and care as researchers learn more about these radiation therapies and how they can improve treatment for breast cancer patients.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 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.
• • Women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation.
• • Ability to understand and willingness to participate in the research and sign the informed consent form.
• • Exclusion Criteria
• • 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.