Clinical trial NCT06826885: Safety and Efficacy of IMPT or IMRT for Breast Cancer
Official title: The Safety and Efficacy of IMPT or IMRT for Breast Cancer: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Proton Therapy
Intensity Modulated Radiation Therapy
Efficacy and Safety
Radiotherapy, Adjuvant
Keywords: postoperative radiotherapy
preoperative radiotherapy
IMPT
IMRT
breast cancer
efficacy
toxicity
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Cancer Hospital and Institute
name: Sichuan Cancer Hospital and Research Institute
name: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
name: Tongji Hospital
First posted: 2025-02-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients aged ≥18 years with histologically confirmed disease and indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy, as determined by the treating physician, who are willing to receive radiotherapy using IMPT or IMRT.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complication Rate of ≥Grade 2 Acute Radiation-Induced Toxicity
timeFrame: 6 months
Secondary outcomes:
measure: Complication Rate of ≥Grade 2 Late Radiation-induced Toxicity
timeFrame: 5 years
measure: Locoregional recurrence
timeFrame: 5 years
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: 5 years
measure: Invasive Recurrence-Free Survival (iRFS)
timeFrame: 5 years
measure: Overall Survival (OS)
timeFrame: 5 years
measure: Pathologic Complete Response (pCR) Rate After Preoperative Radiotherapy
timeFrame: 8-12 weeks
measure: Progression-Free Survival (PFS) After Definitive Radiotherapy
timeFrame: 5 years
measure: Objective Response Rate (ORR) After Definitive Radiotherapy
timeFrame: 3 to 12 months
measure: Disease Control Rate (DCR) After Definitive Radiotherapy
timeFrame: 3 to 12 months
Other outcomes:
measure: Quality of Life using self-administered questionnaire EORTC QLQ-C30
timeFrame: 5 years
measure: Number of Participants with Excellent or Good Cosmetic Outcomes Following Breast-Conserving Surgery
timeFrame: 5 years
measure: Patient-Reported Outcomes (PRO) survey
timeFrame: 5 years
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Gang Cai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Jia-Yi Chen, PhD, MD
role: STUDY_CHAIR
References: