About this trial
The most common cancer affecting Canadian women is breast cancer, with an estimated 1 in 8 women expected to be diagnosed with breast cancer during their lifetime. Improved screening and treatment have decreased mortality of breast cancer patients, however 14% of cancer-related deaths in Canadian women are still due to breast cancer. Common treatments for breast cancer include surgery, chemotherapy, hormone therapy, and radiation therapy (RT).
Despite recent improvements in treatment and preventative screenings, 20% of breast cancer patients will develop local disease recurrence or another ipsilateral primary breast cancer. . The optimal treatment of recurrent or new primary breast cancers for patients who have undergone prior radiotherapy (RT) is not well-defined. Common treatment approaches consist of mastectomy or a second breast conserving surgery (BCS) with whole or partial breast reirradiation (reRT). In the past, mastectomy has been the preferred treatment for recurrent breast cancer due to concerns over serious acute and late skin toxicities that may result from additional reRT. Many of these late skin toxicities, such as fibrosis, are chronic and can result in patients experiencing pain or other negative impacts to quality of life (QOL).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old
Informed consent
Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes
Previous history of ipsilateral breast cancer treated with RT
Disqualifiers
Patients scheduled to receive conventionally fractionated (50Gy/25 or 45Gy/25) or extreme hypofractionation (26Gy/5)
Patients planned to receive brachytherapy
Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion
Concomitant cytotoxic chemotherapy
Trial population
Patients with recurrent ipsilateral breast cancer who satisfy the eligibility criteria will be approached for the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Effects of hypofractionated reRT (40Gy in 15 fractions) on acute skin toxicity
To examine the effects that hypofractionated reRT (40Gy in 15 fractions) has on acute skin toxicity in patients with recurrent ipsilateral breast cancer.
Secondary outcomes
Impact of QOL due to hypofractionated reRT for breast cancer measured via Skindex 16
To evaluate the development of acute skin toxicities and the impact on quality of life due to adverse events caused by using hypofractionated reRT by using the Skindex-16 assessment tool.
Impact of QOL due to hypofractionated reRT for breast cancer measured via RISRAS
To evaluate the development of acute skin toxicities and the impact on quality of life due to adverse events caused by using hypofractionated reRT by using the RISRAS assessment tool.
Sponsors and contacts
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