Comparing two types of radiation therapy for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to compare the safety and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) in breast cancer patients requiring radiotherapy. Eligible participants will receive either preoperative, postoperative, or definitive radiotherapy based on their treatment needs and physician recommendations. The study will monitor patients for at least five years to assess radiation-induced toxicities, cancer recurrence, overall survival, and quality of life. The choice between IMPT and IMRT will be made collaboratively by the patient and their healthcare team, considering various factors such as patient preference and reimbursement policies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Gang Cai, MD — Ruijin Hospital
• Study coordinator: Gang Cai, MD
• Email: cg11855@rjh.com.cn
• Phone: +86-021-64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.