Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
About this study
To de-escalate radiation therapy in women with breast cancer.
- Condition
- Breast Cancer
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
Who can join
- Age
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 50 years
- Eligible sex: Female
- Study condition: Breast Cancer
- 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 \[defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)\].
Exclusion 12
- Age less than 50 years.
- Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).
- Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast).
- Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.
- Synchronous contralateral in-situ or invasive breast cancer.
- BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer.
- 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.
- Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment).
- Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated.
- Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status \> 3.
- Inability to provide informed consent.
Where
27 sites, 27 recruiting
Monash Medical Centre -Moorabbin
Bentleigh East, Victoria, Australia
Maroondah Hospital
Box Hill, Australia
Tweed Valley Hospital
Cudgen, Cudgen, Australia
Victorian Breast & Oncology Care (VBOC)
East Melbourne, Victoria, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
and 21 more sites on ClinicalTrials.gov
Contact
-
Adrianne Van Dam
905-527-2299 avandam@mcmaster.ca
Potential match only. Final eligibility is determined by the study team.