Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB
Phase 2
Terminated
- Conditions
- Breast Cancer
- Interventions
- Radiation: APBI (Dose Escalation)Device: Contura MLB Breast Brachytherapy Catheter
- Registration Number
- NCT01072838
- Lead Sponsor
- SenoRx, Inc.
- Brief Summary
To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
- Life expectancy > 10 years
- Lumpectomy with clear margins (negative per NSABP criteria)
- DCIS and/or invasive carcinoma
- If invasive, nodes must be negative
- T stage is Tis, T1 or T2<=3 cm max diameter
- ER(+) or ER(-)/PR(+)
Exclusion Criteria
- Pregnant or breast feeding
- Active collagen-vascular disease
- Paget's disease of the breast
- Prior history of breast cancer
- Prior breast or thoracic radiotherapy
- Multicentric carcinoma
- Synchronous bilateral breast cancer
- Surgical margins that cannot be assessed or that are positive
- T Stage is T2>3 cm or greater
- ER(-)/PR(-)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Escalation APBI (Dose Escalation) - Dose Escalation Contura MLB Breast Brachytherapy Catheter -
- Primary Outcome Measures
Name Time Method Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI. 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States