Clinical trial · Interventional
Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB
Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial
NCT01072838CI-TRIAL-00010727terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APBI (Dose Escalation) | Radiation | — | UNRESOLVED |
| Contura MLB Breast Brachytherapy Catheter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Dose Escalation
- interventionNames
- Radiation: APBI (Dose Escalation)
- Device: Contura MLB Breast Brachytherapy Catheter
Primary outcomes (1)
- measure
- Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI.
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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(-)
References
Publications (0)
Data not yet available
No reference posted for this study.