A Randomized Phase II Trial of Hypofractionated Radiotherapy for Non-Metastatic Breast Cancer Before or After Breast Surgery for Different Breast Cancer Risk Groups
Mayo Clinic
Summary
This phase II trial studies how well hypofractionated radiotherapy before (preoperative) or after (postoperative) breast surgery works in treating patients with different types of non-metastatic (has not spread from original tumor site) breast cancer and to determine the outcomes and side effects of this treatment. Radiation therapy is considered an integral part of breast conserving therapy. Hypofractionated radiation therapy is a radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less than once a day. This has been shown to be an effective treatment for breast cancer while reducing treatment time and decreasing side effects. Preoperative radiotherapy alone or concurrently with chemotherapy has also been tested with excellent results and with minimal toxicity. Preoperative radiation of the intact tumor with a hypofractionated regimen can potentially decrease toxicity by allowing the delivery of treatment to intact breast tissue. The potential advantages of preoperative radiation therapy include the delivery of radiation in the intact breast when radiation can be more effective as more oxygen can be available in the tissue. Furthermore, complications and cosmetic results are expected to be lower in pre-operative radiotherapy before surgery, as there have been no changes in blood supply to the breast. This lends to the possibility of using lower doses of radiotherapy to patients, and potentially better cancer associated clinical outcomes for our breast cancer patients. Undergoing hypofractionated radiation therapy before or after breast surgery may be safe and effective in treating patients with different types of non-metastatic breast cancer.
Description
PRIMARY OBJECTIVE: I. Compare the rate of grade (G)3 or higher radiation treatment related adverse events with the use of preoperative and postoperative radiation within the first 2-years for groups A-D. CORRELATIVE AND EXPLORATORY OBJECTIVES: I. Grade 3 wound complications and seroma infection between preop and postoperative radiation. II. Locoregional control with or without surgery at 2-years in group D (Her2+). III. To evaluate radiographic complete response and near complete response. IV. To estimate the 5-year locoregional control, distant recurrence, invasive disease-free survival,…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Age \>= 18 years * Histological confirmation of breast cancer * Clinical stage T1-T4 N0-3 M0 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 * Able to and provides Institutional Review Board (IRB)-approved study specific written informed consent * Able to complete all mandatory tests listed in the trial * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Indications for radiotherapy for breast cancer Exclusion Criteria: * Medical contraindication to receipt of radiotherapy * Severe ac…
Interventions
- ProcedureBiopsy of Breast
Undergo breast biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBreast Surgery
Undergo breast surgery
- DrugChemotherapy
Receive SOC chemotherapy
- ProcedureComputed Tomography
Undergo CT
- ProcedureContrast Enhanced Digital Mammography
Undergo CEDM
- RadiationHypofractionated Radiation Therapy
Location
- Mayo Clinic in ArizonaScottsdale, Arizona