PIONEER - Clinical trial • Breast Cancer Foundation NZ

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PIONEER

Recruiting
Updated: June 11, 2021

This study will investigate whether delivering radiation therapy while patients are in a prone position can help minimise skin toxicities ahead of surgery.

PIONEER aims to find out the best way of delivering radiation therapy to the breast tissue before surgery. In order to do that, women will lay in a prone position (on the stomach), so that the breast can fall naturally forward and away from the chest. The cancer inside the breast tissue is treated to a very high dose before it is removed. The aim is to minimise skin toxicities to help the surgeons perform the operation and reconstruction, all in one surgery.

It is hoped that information from this study may help improve the treatment for other patients with invasive type of breast cancer in the future and will help evaluate the new position and treatment doses for future breast radiotherapy treatment.

Who is it for?

You may be eligible to join this study if you are aged 18 years or older and have a histologically confirmed invasive, Grade 1, 2 or 3 breast carcinoma with a primary tumour graded as T2, T3 or T4 and N1+.

Study details

This study will take about one year to recruit 20 participants suitable for radiotherapy in the prone position. On average, the total study duration is expected to be three months for each participant.

Radiotherapy treatment will commence at least four weeks after completion of standard chemotherapy and it will be delivered in the prone position, five days a week from Monday to Friday, over five weeks (25 fractions, 2Gy/fraction).

One week before the radiotherapy treatment, the radiotherapy planning will be booked and the session will take approximately one hour.

During the study, clinical assessments will be performed once a week during the treatment and then two and four weeks after radiotherapy completion. Each visit will take approximately one hour.

Four to eight weeks following successful completion of radiotherapy participant will have a surgery to remove the breast and immediate breast reconstruction. Thirty days after the surgery each patient will have their last study visit (a post-surgical assessment to evaluate any side effects and surgical complications).

Full trial information

Australia

Peter MacCullum Cancer Centre, Melbourne

Contact:

Fiona Hegi-Johnson

If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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