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

Institute of Cancer Research0 sites192 target enrollmentJune 6, 2022

Overview

No summary available.

Registry

who.int

Start Date

June 6, 2022

End Date

February 1, 2030

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.

•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