Comparing proton and photon therapy for left-sided breast cancer

A Prospective Cohort Study Comparing Proton and Photon Hypofractionated Radiotherapy for Left-sided Breast Cancer.

This study is testing whether proton therapy is safer and more effective than photon therapy for people with left-sided breast cancer after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 780 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Shanghai Proton and Heavy Ion Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai)
• Trial ID: NCT06677879 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include women aged 18-80 with histologically confirmed invasive left-sided breast cancer requiring adjuvant radiotherapy after lumpectomy or mastectomy.

Not a fit: Patients with distant metastasis or those who do not meet the specific staging criteria for inclusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the safer and more effective radiotherapy option for patients with left-sided breast cancer.

How similar studies have performed: Other studies have explored the efficacy of proton versus photon therapy, but this specific comparison in the context of left-sided breast cancer is relatively novel.

Eligibility criteria

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 this trial is running

Shanghai

• Shanghai Proton and Heavy Ion Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Ping Li, M.D.

Conditions Breast Cancer; breast cancer; proton therapy; photon therapy