To de-escalate radiation therapy in women with breast cancer.
Eligibility
Sex
FEMALE
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).
2. Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.
3. Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.
4. Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.
5. Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection).
6. Final pathology demonstrating a pCR \[defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)\].
Exclusion Criteria:
1. Age less than 50 years.
2. Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).
3. Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast).
4. Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.
5. Synchronous contralateral in-situ or invasive breast cancer.
6. BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer.
7. Other previous non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers or other cancers curatively treated with no evidence of disease for ≥ 5 years.
8. Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment).
9. Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated.
10. Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy.
11. ECOG (Eastern Cooperative Oncology Group) performance status \> 3.
12. Inability to provide informed consent.
Primary outcome measure(s)
Ipsilateral breast tumour recurrence (IBTR) — 5 years defined as ipsilateral recurrence (invasive or insitu) in the ipsilateral breast or chest wall. Histological evidence of IBTR is required. All such events will be reviewed by a central adjudication committee.
Trial sites (27)
Facility
City
Region
Status
Tweed Valley Hospital
Cudgen
Cudgen
Recruiting
Liverpool Hospital
Liverpool
New South Wales
Recruiting
Mater Hospital Sydney
North Sydney
New South Wales
Recruiting
Westmead Hospital
Westmead
New South Wales
Recruiting
Royal Brisbane and Women's Hospital
Herston
Queensland
Recruiting
Princess Alexandra Hospital
Woolloongabba
Queensland
Recruiting
Monash Medical Centre -Moorabbin
Bentleigh East
Victoria
Recruiting
Victorian Breast & Oncology Care (VBOC)
East Melbourne
Victoria
Recruiting
Peter MacCallum Cancer Centre
Melbourne
Victoria
Recruiting
St. Vincent's Hospital Melbourne
Melbourne
Victoria
Recruiting
Sir Charles Gairdner Hospital
Nedlands
Western Australia
Recruiting
Maroondah Hospital
Box Hill
Australia
Recruiting
Royal Perth Hospital
Perth
Australia
Recruiting
Prince of Wales Hospital
Randwick
Australia
Recruiting
Latrobe Regional Health
Traralgon
Australia
Recruiting
BC Cancer - Centre for the North
Prince George
British Columbia
Recruiting
Royal Victoria Regional Health Centre
Barrie
Ontario
Recruiting
Juravinski Cancer Centre
Hamilton
Ontario
Recruiting
Cancer Centre of Southeastern Ontario at Kingston
Kingston
Ontario
Recruiting
Thunder Bay Regional Health Sciences Centre
Thunder Bay
Ontario
Recruiting
Sunnybrook Health Sciences -Odette Cancer Centre
Toronto
Ontario
Recruiting
CHUM - Centre Hospitalier de L'Université de Montréal
Montreal
Quebec
Recruiting
Jewish General Hospital
Montreal
Quebec
Recruiting
CHU de Quebec - Universite Laval
Québec
Quebec
Recruiting
Centre hospitalier de Lanaudière
Saint-Charles-Borromée
Quebec
Recruiting
Centre Hospitalier Trois Rivieres Ste-Marie
Trois-Rivières
Quebec
Recruiting
McGill University Health Centre (MUHC)
Montreal
Q
Recruiting
More Ontario Clinical Oncology Group (OCOG) trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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