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โ† Trials
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Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy

Recruitingn/aAges 50 Years - anyFemaleOntario Clinical Oncology Group (OCOG)
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In plain words

What the trial is, and whether it could suit you

To de-escalate radiation therapy in women with breast cancer.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • Not listed
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Where

27 sites
Tweed Valley Hospital
Cudgen, Australia
Liverpool Hospital
Liverpool, Australia
Mater Hospital Sydney
North Sydney, Australia
Westmead Hospital
Westmead, Australia
Royal Brisbane and Women's Hospital
Herston, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Monash Medical Centre -Moorabbin
Bentleigh East, Australia
Victorian Breast & Oncology Care (VBOC)
East Melbourne, Australia

โ€ฆand 19 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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