A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.

Phase 2

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06677879
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

Brief Summary

The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are:

1. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery?

2. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 780

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years	Until 2 years after radiotherapy	We will record the incidence of ≥ 2 degree radiation-associated toxicity, such as breast or chest wall oedema, dermatitis, breast pain, esophagitis, rib fracture, radiation pneumonia and hypothyroidism and so on. The incidence of all the above is the primary outcome.

Secondary Outcome Measures

Name	Time	Method
Late toxicities after 2 years of radiotherapy	Until 5 years after radiotherapy	Evaluation of long-term adverse effects (greater than 2 years) after radiotherapy (including radiation pulmonary fibrosis, radiation skin fibrosis, rib fracture, brachial plexus injury, upper limb lymphedema, heart injury, hypothyroidism, etc.)
Locoregional recurrence (LRR)	Until 5 years after treatment.	To estimate and compare the rate of local recurrence between the proton and photon arms
Disease-free survival (DFS)	Until 5 years after treatment.	Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.
Overall survival (OS)	Until 5 years after treatment.	Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.
Quality of life	During last week of radiotherapy, at 3 months post radiotherapy and 1,3 and 5 years post radiotherapy	Impact on quality of life will be assessed with the European Organization for Research in Treatment of Cancer and the Breast Cancer Specific Module 23
Cosmetic outcome	Until 5 years after treatment.	photographic cosmetic scores by BCCT.core

Trial Locations

Locations (1)

Shanghai Proton and Heavy Ion Center; 🇨🇳 Shanghai, China