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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01072838

Enrollment

Registered

2010-02-22

Start date

2009-12-31

Completion date

2013-06-30

Last updated

2013-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, APBI, brachytherapy, Contura

Brief summary

To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.

Interventions

RADIATIONAPBI (Dose Escalation)

Accelerated, hypofractionated partial breast radiotherapy. 3 dose schemes followed for 6 months each.

DEVICEContura MLB Breast Brachytherapy Catheter

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to No maximum

Healthy volunteers

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(-)

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026