Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03137693|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Breast Cancer Female Breast Adenocarcinoma||Other: Standard of Care Schedule Variation: SABR Procedure: Breast-conserving Surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer: Introduction of a Novel Form of Accelerated Partial Breast Radiotherapy|
|Actual Study Start Date :||November 29, 2017|
|Actual Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||June 2021|
Change in Procedure Scheduling
Pre-Surgery SABR: Treatment with Stereotactic Ablative Body Radiation Therapy (SABR) followed by breast-conserving surgery. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.
Other: Standard of Care Schedule Variation: SABR
SABR will be delivered over 3 days, prior to surgery.
Procedure: Breast-conserving Surgery
Breast-conserving surgery will be scheduled for 6-8 weeks after SABR and will be conducted by a Moffitt breast surgeon.
- Rate of Pathologic Complete Response (pCR) [ Time Frame: 6 weeks post SABR ]Rate of pathologic complete response following pre-operative SABR for early-stage breast carcinoma. pCR: The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of the neoadjuvant treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137693
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Michael Montejo||H. Lee Moffitt Cancer Center and Research Institute|