RecruitingNCT05866458
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy
Sponsor
Ontario Clinical Oncology Group (OCOG)
Enrollment
352 participants
Start Date
Mar 12, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
To de-escalate radiation therapy in women with breast cancer.
Eligibility
Sex: FEMALEMin Age: 50 Years
Inclusion Criteria6
- 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 Criteria12
- 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.
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT05866458
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