No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
171 (estimated)
Sponsor
University Health Network, Toronto · Other
Who this trial is looking for
This trial is looking for women with breast cancer that has come back or a new tumor in the same breast after previous radiation treatment. Participants will receive a shorter, one-week course of targeted radiation after surgery.
Are You a Good Fit for This Trial?
Rules you outSerious non-malignant diseasePregnancyBreastfeedingPsychiatric disorders
You may be able to join if
I am over 18 years old
I have in-breast recurrence or a new primary breast cancer
My tumor is 3.0 cm or smaller
I completed prior radiation treatment over 5 years ago
I do not have any cancer in my lymph nodes
I have clear margins after surgery
I have healed fully from my surgery
You may not be able to join if
I have multicentric disease
My tumor is lobular carcinoma only
I have T4 disease
I have positive lymph nodes or metastatic disease
I have serious non-cancer health issues that prevent me from receiving radiation
I am currently pregnant or breast-feeding
I have an implant or pacemaker in my breast
I cannot start radiation within 16 weeks after surgery
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1…
Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\<13% grade \>3 toxicity).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age \> 18 years
* In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma)
* Tumour \<3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components
* \>5 years after completion of prior adjuvant wh…
Inclusion Criteria:
* Age \> 18 years
* In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma)
* Tumour \<3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components
* \>5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted)
* Clinically node negative
* Negative margins (no tumour on ink)
* Recovered from surgery with the incision completely healed and no signs of infection
Exclusion Criteria:
* Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)
* Tumour histology limited to lobular carcinoma only
* T4 disease
* Node positive or distant metastatic disease
* Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment
* Currently pregnant or lactating
* Presence of an ipsilateral breast implant or pacemaker
* Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy
* Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips).
* Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol
* Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0
* Current or prior diagnosis of bilateral breast cancer
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