Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

Group Type OTHER

APBI (Dose Escalation)

Intervention Type RADIATION

Accelerated, hypofractionated partial breast radiotherapy.

3 dose schemes followed for 6 months each.

Contura MLB Breast Brachytherapy Catheter

Intervention Type DEVICE

Interventions

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APBI (Dose Escalation)

Accelerated, hypofractionated partial breast radiotherapy.

3 dose schemes followed for 6 months each.

Intervention Type RADIATION

Contura MLB Breast Brachytherapy Catheter

Intervention Type DEVICE

Eligibility Criteria

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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(-)

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No