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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Charlotte
Coles
+44 (0)1223 336800
cec50@cam.ac.uk
Dr
PARABLE
Clinical Trial
+44 (0)20 8722 4606
parable-icrctsu@icr.ac.uk
Dr
Anna
Kirby
+44 (0)20 8661 3169
Anna.Kirby@rmh.nhs.uk
More information about this study, what is involved and how to take part can be found on the study website.
Breast cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Proton beam therapy (PBT) is a type of radiation therapy. It uses protons (high-energy charged particles) rather than x-rays to treat cancer. PBT can be more accurately targeted than x-rays, potentially reducing the risks of side effects in normal tissues such as the heart. Researchers want to compare PBT with standard x-ray radiotherapy (RT) in breast cancer patients at a higher risk of side effects from RT. They aim to show that PBT reduces the predicted risk of long-term serious heart damage whilst not increasing other shorter term side effects such as skin changes.
Around 33,000 breast cancer patients/year need RT as part of their treatment. A proportion (around 500/year) are less well served by standard RT due to the need to treat lymph nodes near the breast-bone. A person's body shape can also make treatment difficult. This can result in a lower RT dose where it is needed (reducing the likelihood of cure), and/or an unwanted dose to healthy tissues such as the heart (increasing the risk of serious heart damage many years later). PBT has been used in other countries to treat breast cancer, but numbers are small with no direct comparison with RT. PBT is different from RT as it delivers dose to a defined depth thereby giving better dose coverage where needed with a lower dose to the heart. Increased skin and rib side effects have however been reported around 2 years after treatment, although this is mostly with older PBT techniques delivered over 5 weeks. UK standard RT is delivered over 3 weeks as clinical trials have shown this to be as good as 5 weeks with fewer side effects. The NHS has two PBT centres in Manchester (opened 2018) and London (opening 2021). We now have a unique opportunity to compare 3-week PBT with 3-week RT for this patient group with unmet need.
To confirm that PBT reduces rare but life-threatening side effects such as heart attacks compared with RT would need over 10,000 patients in a clinical trial lasting 15-20 years. This is not feasible and would mean large numbers of patients being exposed to less than optimal treatment in the meantime. The researchers plan an efficient clinical trial using average heart dose, a short term predictor for later heart damage, to deliver a result much earlier. They will invite breast cancer patients who have at least a 2 in 100 predicted lifetime risk of serious heart side effects from their planned RT to receive either PBT (Manchester/London) or RT (local centre). The choice of PBT or RT will be decided randomly by a computer to minimise bias. The researchers will compare the average heart dose received with PBT to that received with RT and use symptoms reported by patients at 2 years after treatment to compare other side effects in and around the breast. Outcomes and side effects will be collected for 5 years and NHS databases will be used to collect even longer-term effects.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 20/11/2024:
1. Age ≥18 years, female or male
2. Histologically proven invasive breast carcinoma treated with:
2.1. Breast conservation surgery with axillary surgery (biopsy or dissection) OR
2.2. Mastectomy with axillary surgery (biopsy or dissection)OR
2.3. In the case of an occult breast primary, axillary surgery (biopsy or dissection) only is permissible
3. Recommended to undergo RT to the breast/chest wall +/- axilla +/- IMN
4. Estimated lifetime risk of radiation-induced late cardiac toxicity around 2% or higher*
* Calculated from tables of mean heart dose, age and cardiovascular risk factors (pre-existing cardiac disease, other circulatory diseases, diabetes, chronic obstructive pulmonary disease, smoking, body mass index >30 kg/m2)(10).
N.B. Mean heart dose is estimated using wide-tangent field placement in deep inspiration breath hold (DIBH)) as this is the commonest technique for IMN RT in the UK and can be carried out quickly to ensure an efficient patient pathway.
5. Ability to provide written informed consent t
You may not be able to take part if:
Current exclusion criteria as of 20/11/2024:
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.5. Breast tissue expander implants with integrated metallic injection ports are contraindicated and not permitted within PARABLE.
_____
Previous exclusion criteria:
1. Definitive clinical or radiological evidence of metastatic disease 2. Prior RT to the ipsilateral chest wall, breast and thorax3. 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Anna
Kirby
+44 (0)20 8661 3169
Anna.Kirby@rmh.nhs.uk
Prof
Charlotte
Coles
+44 (0)1223 336800
cec50@cam.ac.uk
Dr
PARABLE
Clinical Trial
+44 (0)20 8722 4606
parable-icrctsu@icr.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Institute of Cancer Research and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR131120.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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