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
Plain Language Summary
Simplified for easier understanding
This study (ROSACAL) investigates whether radiation therapy can be safely skipped after lumpectomy (breast-conserving surgery) in women with breast cancer who had a complete pathological response to chemotherapy given before surgery — meaning no cancer was detectable in the removed tissue or lymph nodes.
**You may be eligible if...**
- You are 50 years or older
- You have node-negative breast cancer (no spread to lymph nodes at diagnosis)
- You completed at least 8 weeks of chemotherapy before surgery, achieving a complete response (no remaining cancer in the breast or lymph nodes after surgery)
- You had breast-conserving surgery with axillary staging
- A clip was placed in your tumor bed before or during chemotherapy
**You may NOT be eligible if...**
- You are under 50 years of age
- You have inflammatory breast cancer or cancer invading skin or chest wall
- You have a BRCA1 or BRCA2 gene mutation
- You have cancer in multiple areas of the same breast
- You have had a previous breast cancer in the same or other breast
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Locations(23)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05866458
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