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NCT Number: NCT06677879

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

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?

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Proton and Heavy Ion Center

Shanghai, China

Location status: Recruiting

Location contact

Jin Meng, Ph.D

CONTACT

Ping Li, M.D.

CONTACT

[email protected]

021-38296538

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Until 2 years after radiotherapy

    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.

Secondary outcomes

  1. Late toxicities after 2 years of radiotherapy

    Time frame: Until 5 years after radiotherapy

    Evaluation of long-term adverse effects (greater than 2 years) after radiotherapy (including radiation pulmonary fibrosis, radiation skin fibrosis, rib fracture, brachial plexus injury, upper limb lymphedema, heart injury, hypothyroidism, etc.)

  2. Locoregional recurrence (LRR)

    Time frame: Until 5 years after treatment.

    To estimate and compare the rate of local recurrence between the proton and photon arms

  3. Disease-free survival (DFS)

    Time frame: Until 5 years after treatment.

    Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.

  4. Overall survival (OS)

    Time frame: Until 5 years after treatment.

    Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.

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

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

    Impact on quality of life will be assessed by EORTC Quality of Life Questionnaires-B23；Which include functional domains, global health status and symptom scales.

  6. Cosmetic outcome

    Time frame: Until 5 years after treatment.

    photographic cosmetic scores by BCCT.core

Study contacts

Contact information is provided by the study sponsor or research team.

Ping Li, M.D.

CONTACT

[email protected]

021-38296666

Sponsors and collaborators

Lead sponsor

Shanghai Proton and Heavy Ion Center

Other

Registry information

Official study title

A Prospective Cohort Study Comparing Proton and Photon Hypofractionated Radiotherapy for Left-sided Breast Cancer.

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Nov 7, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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