Safety and Efficacy of IMPT or IMRT for Breast Cancer

Recruiting

• Conditions: Breast Cancer; Proton Therapy; Intensity Modulated Radiation Therapy; Efficacy and Safety; Radiotherapy, Adjuvant

• Registration Number: NCT06826885
• Lead Sponsor: Ruijin Hospital

Brief Summary

The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and/or regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

Detailed Description

Eligible breast cancer patients will receive either preoperative, postoperative, or definitive radiotherapy based on the MDT's recommendation. Patients with indications for treatment will receive either the IMPT or IMRT technique. The specific technique will be chosen based on the benefits of IMPT, patient preference, and reimbursement policies after discussion between the doctor and the patient. The primary endpoint is the occurrence of any acute radiation-induced toxicities of grade ≥2. Patients will be monitored for at least five years to evaluate acute and late radiation-induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Primary Completion: 2029-11-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication Rate of ≥Grade 2 Acute Radiation-Induced Toxicity	6 months	Acute radiation-induced toxicities will be assessed and recorded from the start of radiotherapy to six months after its completion. Evaluations will occur weekly during treatment, and at 2 weeks, 4 weeks, 3 months, and 6 months post-treatment. The assessment will utilize the Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) After Definitive Radiotherapy	5 years	The duration from the initiation of definitive radiotherapy to the earliest occurrence of any of the following events: Disease Progression: As determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.; Death: From any cause. Last Follow-Up: If neither progression nor death occurs during the study period.
Disease Control Rate (DCR) After Definitive Radiotherapy	3 to 12 months	The percentage of patients who achieve a complete response (CR), partial response (PR), or stable disease (SD) to definitive radiotherapy, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Complication Rate of ≥Grade 2 Late Radiation-induced Toxicity	5 years	From six months after the completion of radiotherapy to five years post-treatment, any late radiation-induced toxicity will be assessed and recorded every six months during the first two years, and annually thereafter. Assessments will utilize the Radiation Therapy Oncology Group (RTOG) /European Organization for Research on Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and CTCAE 5.0
Locoregional recurrence	5 years	Any first recurrence confirmed by histology or cytology within the ipsilateral breast or chest wall and/or regional nodes area (including supraclavicular, infraclavicular, axillary, or internal mammary lymph nodes)
Pathologic Complete Response (pCR) Rate After Preoperative Radiotherapy	8-12 weeks	The percentage of patients who achieve ypT0/is and ypN0 (no invasive residual in the breast or lymph nodes) after preoperative radiotherapy.
Objective Response Rate (ORR) After Definitive Radiotherapy	3 to 12 months	The percentage of patients who achieve a complete response (CR) or partial response (PR) to definitive radiotherapy, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Distant Metastasis-Free Survival (DMFS)	5 years	The duration from the date of enrollment to the occurrence of any breast tumor recurrence at distant sites, death from any cause, or the last follow-up.
Invasive Recurrence-Free Survival (iRFS)	5 years	The duration from the date of enrollment to the occurrence of the first invasive breast tumor recurrence, death from any cause, or the last follow-up.
Overall Survival (OS)	5 years	The duration from the date of enrollment to the date of death from any cause or the last follow-up.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China