Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Carcinoma In Situ

Acute Graft Versus Host Disease

Patient will be treated in a supine position as per standard of care/control.

Patient will be treated in the prone position.

All participants will receive an adjuvant XRT dose to the breast of 50Gy in 25 fractions using an IMRT technique. In both arms, boost to the surgical bed using a mini-tangent technique will be delivered at the treating oncologist's discretion. Acceptable boost doses are 1600cGy/8 fractions, 1000cGy/5 fractions or 1325cGy/25 fractions as a simulatenous integrated boost. Participants randomized to the supine arm will be positioned supine on an angled breast board, with the ipsilateral arm abducted over her head. Participants randomized to the prone arm will be positioned prone on a prone breast board with both arms immobilized above the participant's head. The us of a cushion-like VaclocTM device is permitted at the treating physician's discretion. Radiation beams will be shaped to encompass the breast volume requiring treatment in both arms.

Radiation Therapy Positioning Intervention

Danny Vesprini, MD MSc FRCPC

Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size.

After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life.

This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.

The risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. Evidence suggests that the use of a prone breast IMRT technique has the potential to decrease the risk of moist desquamation in large breasted women to the levels that are now seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes of providing motivation for this study, a multicentre RCT is feasible to confirm and quantify the improvement provided by the prone technique and provide Level 1 evidence for it to be adopted world-wide.

The Prone Breast Radiation Therapy Trial

A Multicentre Randomized Controlled Clinical Trial for the Reduction of Acute Skin Reaction in Adjuvant Breast Radiation in Large Breasted Women Using a Prone Technique - The Prone Breast Trial

Change in health related Quality of Life as per the EORTC core QoL questionnaire QLQ-C30 and the breast cancer module QLQ-BR23.

Acute moist desquamation rates as measured by CTCAE 4.03 during and up to 6-8 weeks post treatment.

Acute breast pain rates as measured by CTCAE 4.03 and Visual Analog Scale (VAS) during and up to 6-8 weeks post treatment.

Determine if adjuvant breast IMRT in the prone position produces improved dose distribution in regards to exposure to critical structures including heart, lung, liver and contralateral breast when compared to treatment in the supine position.

Canadian Breast Cancer Foundation

Toronto Sunnybrook Regional Cancer Centre

Radiation Oncologist

Breast Diseases

Skin Diseases

Via tubes placed at the time of wide local excision delivered over 5 days

Interstitial Implant Brachytherapy

Alphonse Taghian, MD, PhD

The purpose of this study is to evaluate radiation therapy directed to a small region of the breast in women who were recently diagnosed with early stage invasive breast cancer.

* When participants undergo surgery to remove the tumor (lumpectomy), it will be followed by the placement of small flexible tubes throughout the region surrounding the site of operation. These tubes will remain in place for 7-9 days following the surgery.
* The first 2-3 days, the tubes will not contain radioactivity. This time is used to do all the calculations necessary for treatment and to check the findings in the breast tissue that was removed. After 2-3 days, the tubes will be filled with a radioactive wire which will remain in place for the next 5 days. During this period of time, participants will be required to remain within the hospital. At the end of these 5 days, the radioactive wires and tubes will be removed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Prone Breast Radiation Therapy Trial	NCT01815476	Ductal Carcinom... Invasive Breast...	Radiation Thera...	-	Toronto Sunnybrook Regional Cancer Centre
Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant	NCT00977275	Breast Cancer	Interstitial Im...	18 Years -	Massachusetts General Hospital
Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant	NCT00977275	Breast Cancer	Interstitial Im...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for early stage invasive breast cancer