The primary objective of this study is to determine if hypofractionated RT delivered over 1 week to the breast or chest wall and regional nodes (26Gy in 5 daily fractions) following BCS or mastectomy, is non-inferior to conventional fractionation to the breast or chest wall and regional nodes delivered over 3 weeks (40Gy in 15 daily fractions) in patients with node-positive breast cancer.
A multi-centre, randomized, non-inferior, phase III study comparing two radiation treatment modalities, conventional fractionation with hypofractionation for locoregional RT. Eligible, consenting patients with newly diagnosed and histologically confirmed invasive carcinoma of the breast without evidence of metastatic disease; treated with definitive surgery \[BCS or mastectomy with nodal staging using sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)\] will be randomized in a 1:1 fashion to either conventional locoregional RT (control group) or hypofractionated locoregional RT (experimental group). Stratification factors include: body mass index, the performance of ALND, type of surgery (BCS or mastectomy) and clinical centre. Study participants will be assessed for lymphedema, the primary outcome, by measuring arm volume. Arm mobility will be assessed by measuring arm movement. Study participants will be assessed for acute and late radiation toxicities, during and post RT. Study participants will be followed and assessed annually for breast cancer recurrence (BCR), new second cancers, quality of life (QOL) and overall survival. Cost effectiveness and cost utility will also be determined. The planned sample size is 588 study participants. The study will be conducted at clinical centres throughout Canada.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
588
40 Gray in 15 daily fractions over 3 weeks
26 Gray in 5 daily fractions over 1 week
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Lymphedema
Lymphedema defined as relative volume change (RVC) ≥10%
Time frame: 3 years post randomization
Breast cancer recurrence
Both locoregional and distant recurrence and second cancers
Time frame: Annually for 5 years post randomization
Mortality
Survival
Time frame: Annually for 5 years post randomization
Radiation toxicity
Acute and late radiation toxicity
Time frame: During last week of radiotherapy, at 3 months post radiotherapy and annually for 5 years post randomization
Arm mobility
Assessed by measuring the straight lateral abduction of both the ipsilateral and contralateral arm
Time frame: 1 and 3 years post randomization
Patient Quality of Life with respect to daily health and activities
Impact on quality of life will be assessed with the European Organization for Research in Treatment of Cancer and the Breast Cancer Specific Module 23. The scale is 1 to 4 where a higher score means a worse outcome.
Time frame: During last week of radiotherapy, at 3 months post radiotherapy and 1 and 3 years post randomization
Perception of lymphedema
Impact of lymphedema on quality of life will be assessed with the National Surgical Adjuvant Breast and Bowel Project questionnaire. The scale is 1 to 5 where a higher score means a worse outcome.
Time frame: During last week of radiotherapy, at 3 months post radiotherapy and 1 and 3 years post randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer - Centre for the Southern Interior
Kelowna, British Columbia, Canada
BC Cancer - Centre for the North
Prince George, British Columbia, Canada
BC Cancer - Vancouver Centre
Vancouver, British Columbia, Canada
BC Cancer - Vancouver Island Centre
Victoria, British Columbia, Canada
Northeast Cancer Centre, Health Sciences North
Greater Sudbury, Ontario, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
...and 10 more locations
Perception of breast cosmesis
Patient-reported breast cosmesis using a Breast Cosmesis Questionnaire to study the late effects of radiation.
Time frame: 1 and 3 years post randomization
Health Care Resource Utilization
Health Care Resource Utilization will be estimated using dates and duration of radiotherapy treatment and emergency department visits and hospitalizations.
Time frame: During radiotherapy, at 3 months post radiotherapy and annually for 5 years post randomization
Patient Costs
Patient costs will be assessed using a Time Off Work Questionnaire to study the financial impact of breast cancer and its treatment
Time frame: During last week of radiotherapy, at 3 months post radiotherapy and 1 and 3 years post randomization