Hypofractionated LocoRegional Radiotherapy in Breast Cancer

Launched by ONTARIO CLINICAL ONCOLOGY GROUP (OCOG) · Jan 10, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way of delivering radiation therapy for patients with breast cancer. Specifically, it is looking at a method called hypofractionated radiation therapy, which means giving a higher dose of radiation in fewer sessions—in this case, over just one week—compared to the traditional method that takes about three weeks. The goal is to find out if this quicker treatment is just as effective as the standard approach for patients who have had surgery for breast cancer and have certain features in their cancer, like positive lymph nodes.

To be eligible for this study, participants should be adults aged 18 or older who have recently been diagnosed with invasive breast cancer and have undergone surgery with clear margins. They should not have any signs of cancer spreading to other parts of the body and must meet specific criteria regarding their cancer stage. If you join the trial, you can expect to receive radiation therapy as part of your treatment plan, and the research team will closely monitor your progress and side effects over the next five years. It’s important to know that this trial is currently recruiting participants, so if you or someone you know might be interested, consider discussing it with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Newly diagnosed invasive carcinoma of the breast.
• • 2. Treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND) with clear margins of excision.\* Note: \*Patients with limited positive posterior margin where disease is resected to chest wall or limited positive anterior margin where disease is resected to dermis are eligible.
• 3. Candidate for locoregional radiotherapy: breast cancer stage after definitive surgery:
• • Neoadjuvant chemotherapy was not administered: pathologic stage T3N0,T1-3 N1-2\*\*
• • \*\* patients with nodal micromets (N1mi) are eligible
• • Neoadjuvant chemotherapy was administered: clinical stage T3N0, T1-3, N1-2 and pathologic stage T0-3, N0-2†
• • Patients who are clinically N1-2 prior to chemotherapy should be confirmed histologically unless it is clear that they are node positive. Patients who are deemed node negative prior to chemotherapy but are node positive following chemotherapy are eligible. Patients who are node positive prior to chemotherapy and who have complete response in the lymph nodes are also eligible.
• • 4. No evidence of metastatic disease.
• Exclusion Criteria:
• • 1. Age \< 18 years.
• • 2. Clinical stages T4 and/or N3.
• • 3. Clinical lymphedema in the ipsilateral arm or breast/chest wall.
• • 4. Any prior history, not including index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with previous ipsilateral DCIS or LCIS not treated with radiation are eligible.)
• • 5. Synchronous or previous contralateral breast cancer.(Patients with previous contralateral DCIS or LCIS not treated with radiation are eligible.)
• • 6. History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma.
• • 7. Neoadjuvant endocrine therapy. (Extended neoadjuvant endocrine therapy is not permitted. Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable.)
• • 8. Breast reconstruction.
• • 9. Presence of known medical conditions that would preclude follow-up for 5 years.
• • 10. Previous radiotherapy to the ipsilateral breast or chest wall or serious non-malignant disease e.g. scleroderma, severe lung or heart disease that would preclude radiotherapy.
• • 11. Known pregnancy or currently lactating.
• • 12. Geographic inaccessibility for follow-up.
• • 13. Inability to provide informed consent.