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

Shanghai Proton and Heavy Ion Center

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer

Treatments: Radiation: Proton radiotherapy; Radiation: Photon radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06677879

SPHIC-TR-BCa2024-01

Details and patient eligibility

About

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?

Enrollment: 780 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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780 participants in 2 patient groups

Proton therapy

Experimental group

Description:

Proton radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer.

Treatment:

Radiation: Proton radiotherapy

photon therapy

Active Comparator group

Description:

Photon radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer.

Treatment:

Radiation: Photon radiotherapy