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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.
This is a randomized, two-arm, single blinded trial comparing two radiation treatment modalities, PBI and WBI. Following BCS or on the completion of additional adjuvant chemotherapy, eligible and consenting patients with newly diagnosed and histologically confirmed invasive carcinoma of the breast (without evidence of metastatic disease); with microscopically clear resection margins of 1mm (or no residual disease on re-excision) and negative axillary node involvement will be randomized in a 1:1 fashion to receive either PBI (experimental group) or WBI (control group). Study participants will receive 26Gy in 5 fractions in both treatment arms, treated once per day, for a period of 5-7 days. Study participants will not be made aware of treatment allocation to prevent any potential bias in their assessment of cosmesis. Stratification factors include tumour size, estrogen receptor (ER) status, and clinical centre.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Breast Irradiation (WBI) | Active Comparator | 26 Gy in 5 fractions to the whole breast |
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| Partial Breast Irradiation (PBI) | Experimental | 26 Gy in 5 fractions to the tumour bed with a margin of normal tissue |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Breast Irradiation (WBI) | Radiation | The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable). |
| Measure | Description | Time Frame |
|---|---|---|
| Local Recurrence | Time from randomization to any evidence of tumour recurrence (invasive and non-invasive) in the treated breast. | Annually for 5 years post-randomization |
| Patient Assessment Cosmesis at 3 years | Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System and the UK Patient Reported Outcomes Questions following BCS. | 3 and 5 years post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Distant Disease Free Survival (DDSF) | Time from randomization to evidence of metastasis involving distant sites (e.g. bone, liver, lung, or brain). | Annually for 5 years post-randomization. |
| Disease Free Survival (DFS) |
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Inclusion Criteria:
For inclusion in this study, patients must fulfill all of the following criteria:
Exclusion Criteria:
Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shelley Chambers, MA | Contact | 905-527-2299 | 42618 | schamber@mcmaster.ca |
| Erin McGean | Contact | 905-527-2299 | 42656 | mcgeane@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Timothy Whelan, M.D. | Juravinski Cancer Centre and McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GenesisCare Darlinghurst | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
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Study participants will be made unaware of treatment allocation to prevent any potential bias in their assessment of cosmesis.
| Partial Breast Irradiation (PBI) | Radiation | The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable). |
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Time from randomization to local recurrence, regional or distant recurrence, contralateral breast cancer, other second cancer, or death.
| Annually for 5 years post-randomization. |
| Overall Survival | Time from randomization to death of any cause. | 3 years post-randomizaton. |
| Radiation Toxicity | Acute (2 weeks and up to 3 months after completing RT) and late toxicity (beyond the 3 months after completing RT) will be assessed by clinical centre personnel using the NCI CTCAE version 5.0. | 2 weeks and 3 months post-radiation treatment, then annually for 5 years post-randomization. |
| Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years. | A nurse/Clinical Research Associate (CRA) assessment of cosmesis using the EORTC Breast Cosmetic Rating System. Nurses and CRAs will be training in assessing cosmesis using training slides and guide previously developed for other trials. | 3 and 5 years post-randomization. |
| Patient Assessed Cosmesis at 5 years. | Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System13,27,42 and the UK Patient Reported Outcomes Questions following BCS. | 5 years post-randomization. |
| Patient Reported Quality of Life | Patients will complete the EORTC Breast Cancer Quality of life questionnaire | 2 weeks post-radiation treatment, then at 3 and 5 years post-randomization. |
| GenesisCare Hurstville | Recruiting | Hurstville | New South Wales | 2220 | Australia |
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| GenesisCare Mater Hospital | Recruiting | North Sydney | New South Wales | 2060 | Australia |
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| GenesisCare Bundaberg | Recruiting | Bundaberg | Queensland | 4670 | Australia |
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| GenesisCare Southport | Recruiting | Southport | Queensland | 4215 | Australia |
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| GenesisCare Tugun | Recruiting | Tugun | Queensland | 4224 | Australia |
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| GenesisCare Hervey Bay | Recruiting | Urraween | Queensland | 4655 | Australia |
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| GenesisCare St Andrew's | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| GenesisCare Bedford Park | Recruiting | Bedford Park | South Australia | 5042 | Australia |
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| GenesisCare Wembley | Recruiting | Wembley | Washington | 6014 | Australia |
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| GenesisCare Fiona Stanley Hospital | Recruiting | Murdoch | Western Austrailia | 6150 | Australia |
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| GenesisCare Hollywood | Recruiting | Nedlands | Western Australia | 6009 | Australia |
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| Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit | Recruiting | Calgary | Alberta | Canada |
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| BCCA-Vancouver Island Cancer Centre | Not yet recruiting | Victoria | British Columbia | Canada |
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| QEII HSC - Nova Scotia Cancer Centre | Recruiting | Halifax | Nova Scotia | Canada |
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| Royal Victoria Regional Health Centre | Recruiting | Barrie | Ontario | Canada |
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| Juravinski Cancer Centre | Recruiting | Hamilton | Ontario | Canada |
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| London Regional Cancer Centre | Recruiting | London | Ontario | Canada |
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| Stronach (Southlake) Regional Health Centre | Recruiting | Newmarket | Ontario | Canada |
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| Algoma District Cancer Program | Recruiting | Sault Ste. Marie | Ontario | Canada |
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| Princess Margaret Hospital | Recruiting | Toronto | Ontario | Canada |
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| Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre | Recruiting | Toronto | Ontario | Canada |
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| Windsor Regional Cancer Centre | Recruiting | Windsor | Ontario | N8W2X3 | Canada |
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| CSSS Champlain - Charles LeMoyne | Recruiting | Greenfield Park | Quebec | Canada |
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| CHUM - Centre Hospitalier de L'Université de Montréal | Recruiting | Montreal | Quebec | H2L 4M1 | Canada |
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| McGill University Health Centre | Recruiting | Montreal | Quebec | Canada |
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| CHUQ-Pavillon Hotel-Dieu de Quebec | Recruiting | Québec | Quebec | Canada |
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| CHUS-Hopital Fleurimont | Recruiting | Sherbrooke | Quebec | J1H5N4 | Canada |
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| Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ) | Recruiting | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
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| Saskatoon Cancer Centre | Recruiting | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
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