Comparing proton and photon therapy for left-sided 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 study investigates the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy for patients with left-sided breast cancer following lumpectomy or mastectomy. It aims to determine the incidence of radiation-related adverse events of grade 2 or higher within two years after treatment with either therapy. The study includes patients with histologically confirmed invasive breast cancer who meet specific staging criteria and have undergone appropriate surgical procedures. By comparing these two treatment modalities, the study seeks to provide insights into their relative safety and effectiveness.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Proton and Heavy Ion Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Ping Li, M.D.
• Email: ping.li@sphic.org.cn
• Phone: 021-38296666

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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.