Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy
Status: Recruiting
Location: See all (11) locations...
Study Type: Observational
SUMMARY
To de-escalate radiation therapy in women with breast cancer.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:
• Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).
• Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.
• Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.
• Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.
• Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection).
• Final pathology demonstrating a pCR \[defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)\].
Locations
Other Locations
Canada
Royal Victoria Regional Health Centre
RECRUITING
Barrie
Juravinski Cancer Centre
RECRUITING
Hamilton
Cancer Centre of Southeastern Ontario at Kingston
RECRUITING
Kingston
CHUM - Centre Hospitalier de L'Université de Montréal
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
McGill University Health Centre (MUHC)
RECRUITING
Montreal
CHU de Quebec - Universite Laval
RECRUITING
Québec
Centre hospitalier de Lanaudière
RECRUITING
Saint-charles-borromée
Thunder Bay Regional Health Sciences Centre
RECRUITING
Thunder Bay
Sunnybrook Health Sciences -Odette Cancer Centre
RECRUITING
Toronto
Centre Hospitalier Trois Rivieres Ste-Marie
RECRUITING
Trois-rivières
Contact Information
Primary
Adrianne Van Dam
avandam@mcmaster.ca
905-527-2299
Time Frame
Start Date:2024-03-12
Estimated Completion Date:2031-10
Participants
Target number of participants:352
Treatments
Single Arm Cohort
The study population consists of women with newly diagnosed T1-3 node negative breast cancer with no clinical evidence of distant metastatic disease, that have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (defined as absence of residual invasive and in situ breast cancer within the breast or lymph nodes).