Clinical trial NCT06677879: A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.
Official title: A Prospective Cohort Study Comparing Proton and Photon Hypofractionated Radiotherapy for Left-sided Breast Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
proton therapy
photon therapy
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 780
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


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.

Primary outcomes:
measure: The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years
timeFrame: Until 2 years after radiotherapy
Secondary outcomes:
measure: Late toxicities after 2 years of radiotherapy
timeFrame: Until 5 years after radiotherapy
measure: Locoregional recurrence (LRR)
timeFrame: Until 5 years after treatment.
measure: Disease-free survival (DFS)
timeFrame: Until 5 years after treatment.
measure: Overall survival (OS)
timeFrame: Until 5 years after treatment.
measure: uality of life, as measured by EORTC Quality of Life Questionnaires-B23
timeFrame: During last week of radiotherapy, at 3 months post radiotherapy and 1,3 and 5 years post radiotherapy
measure: Cosmetic outcome
timeFrame: Until 5 years after treatment.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
Study officials:
References: