Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer
Lay Description
The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
Category
- Cancers and Other Neoplasms
- Breast
- IRB Number
- 20180650HU
- NCT Number
- NCT03488693
Eligibility
- Eligible Ages
- Over 35 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care. - Patients must have been treated by BCS or mastectomy with clear margins of excision. Post-mastectomy positive margins for invasive disease and/or DCIS is not allowed. Multifocal disease (i.e. the presence of two or more foci or breast cancer within the same breast quadrant) and multicentric disease (i.e. the presence of two or more foci of breast cancer in different quadrants of the same breast) are allowed. - Patients with T3N0 disease are eligible. - Patients with disease limited to nodal micrometastases are not eligible - Patients with nodal macrometastases (>2mm) treated by axillary dissection must have 1-3 positive axillary nodes (macrometastases, > 2 mm). - Patients treated by mastectomy and SLNB alone must have only 1 positive axillary node (macrometastases, > 2 mm). - Patients must be ER = 1% and HER2 negative on local testing - Patients must have an Oncotype DX recurrence score =25 obtained from testing of breast tumour tissue from a core biopsy or from the surgical specimen. - Patient must consent to provision of, and investigator(s) must agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative marker assays described in the protocol may be conducted - Patient must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted. - Patients must have had endocrine therapy initiated or planned for = 5 years. Premenopausal women will receive ovarian ablation plus aromatase inhibitor therapy or tamoxifen if adjuvant chemotherapy was not administered. For all patients, endocrine therapy can be given concurrently or following RT. - Patients may or may not have had adjuvant chemotherapy. - RT must be administered within 16 weeks of definitive surgery if the patient is not treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 12 weeks after the last dose. (Note: adjuvant chemotherapy may be ongoing at the time of randomization). Definitive surgery is defined as the last breast cancer-related surgery. - Patient's ECOG performance status must be 0, 1 or 2. - Patient's age must be = 35 years. - For the first 736 eligible English or French-speaking subjects who have agreed to optional questionnaire completion: Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life, health utilities and lost productivity questionnaires in either English or French - Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements - Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. - In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of patient randomization. - Women of childbearing potential must have agreed to use an effective contraceptive method. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months.
Exclusion Criteria
Study Design
Arm Groups
Study Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu
Principal Investigator
Chul Ha