Proton beam therapy in patients with breast cancer: evaluating early and late effects

Not Applicable

• Conditions: Breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN14220944
• Lead Sponsor: Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-06
• Last Update Posted: 3 April 2023
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1. Age =18 years, male or female
2. Histologically proven invasive breast carcinoma treated with wide local excision or mastectomy, and any type of axillary surgery
3. Recommended to undergo RT to the breast/chest wall + internal mammary node (IMN) RT; or if pectus excavatum, recommended to undergo RT to the breast/chest wall +/- IMN RT
4. Estimated lifetime risk of radiation-induced late cardiac toxicity =2%*

*calculated from tables of mean heart dose, age and cardiovascular risk factors (pre-existing cardiovascular disease, diabetes, chronic obstructive pulmonary disease, active smoker, body mass index > 30kg/m2, chronic pain medication, use of anthracycline chemotherapy).

N.B. mean heart dose is calculated from radiotherapy plan using wide tangents in deep inspiration breath hold (DIBH) as this is the most common technique for IMN RT in the UK and can be planned relatively quickly to ensure an efficient patient pathway.

Exclusion Criteria

1. Definitive clinical or radiological evidence of metastatic disease
2. Prior RT to the ipsilateral chest wall, breast and thorax
3. Connective tissue disorders requiring active medical therapy (Patients with a history of connective tissue disorders in whom a multidisciplinary team has agreed that the benefits of radiotherapy outweigh the risks may be included. Methotrexate and/or other immune therapies must be stopped during RT or PBT)
4. Concomitant TDM1 or capecitabine is not permitted

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Mean heart dose (in Gy) using wide-tangent field placement in deep inspiration breath hold (DIBH) at baseline<br> 2. Patient-reported normal tissue toxicity in the breast measured using the EORTC QLQ-BR23 breast symptoms score at 2 years<br>