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 (23) 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
Australia
Monash Medical Centre -Moorabbin
NOT_YET_RECRUITING
Bentleigh East
Maroondah Hospital
RECRUITING
Box Hill
Tweed Valley Hospital
RECRUITING
Cudgen
Victorian Breast & Oncology Care (VBOC)
RECRUITING
East Melbourne
Liverpool Hospital
RECRUITING
Liverpool
St. Vincent's Hospital Melbourne
RECRUITING
Melbourne
Mater Hospital Sydney
RECRUITING
North Sydney
Royal Perth Hospital
NOT_YET_RECRUITING
Perth
Prince of Wales Hospital
RECRUITING
Randwick
Latrobe Regional Health
RECRUITING
Traralgon
Westmead Hospital
RECRUITING
Westmead
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
BC Cancer - Centre for the North
RECRUITING
Prince George
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).