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

NCT06677879 | Recruiting Phase 2 DMC

• 1 other identifier: SPHIC-TR-BCa2024-01
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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. 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. 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?

Conditions

Breast Cancer

Keywords

breast cancer; proton therapy; photon therapy

Outcome Measures

Primary Outcomes (1)

• The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years

  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.

  Until 2 years after radiotherapy

Secondary Outcomes (6)

• Late toxicities after 2 years of radiotherapy

  Until 5 years after radiotherapy

• Locoregional recurrence (LRR)

  Until 5 years after treatment.

• Disease-free survival (DFS)

  Until 5 years after treatment.

• Overall survival (OS)

  Until 5 years after treatment.

• uality of life, as measured by EORTC Quality of Life Questionnaires-B23

  During last week of radiotherapy, at 3 months post radiotherapy and 1,3 and 5 years post radiotherapy

Study Arms (2)

Proton therapy

EXPERIMENTAL

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

Radiation: Proton radiotherapy

photon therapy

ACTIVE COMPARATOR

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

Radiation: Photon radiotherapy

Interventions

Proton radiotherapy RADIATION

Lumpectomy group: The total dose was 40.05Gy (RBE) , 2.67Gy (RBE) per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy (RBE) , 2.66Gy (RBE) per fraction with 16 fractions. Once a day, five times a week.

Proton therapy

Photon radiotherapy RADIATION

Lumpectomy group: The total dose was 40.05Gy, 2.67Gy per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy, 2.66Gy per fraction with 16 fractions. Once a day, five times a week.

photon therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed invasive breast cancer.
• Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left breast cancer:
• Post lumpectomy: Patients who have undergone lumpectomy with postoperative pathology staged as pT1-3 N1-3, excluding N3c.
• 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.
• 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.
• No distant metastasis.
• Age range: 18-80 years.
• Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0-2.
• Non-pregnant and non-lactating women.
• Informed consent: Patients must provide written informed consent prior to receiving radiotherapy.

You may not qualify if:

• Presence of Ductal Carcinoma In Situ (DCIS).
• Tumor staging: Patients presenting with T4, N0, or N3c disease.
• History of prior radiotherapy to the ipsilateral chest or breast.
• Surgical margin status: Margins are either positive or close, defined as:
• Invasive carcinoma within 1 mm of the surgical margin.
• Bilateral breast cancer: Patients with synchronous or previous contralateral breast cancer.

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ping Li, M.D.

CONTACT

021-38296666; ping.li@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

CN (1)