Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy

Phase 4

Terminated

• Conditions: Breast Cancer
• Interventions: Device: Conture Multi-Lumen Balloon

• Registration Number: NCT00699101
• Lead Sponsor: SenoRx, Inc.

Brief Summary

This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.

Detailed Description

Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-17
• Primary Completion: 2011-03
• Status Verified: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-14
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

• Able and willing to sign informed consent

• Age 50 or older at diagnosis

• Life expectancy greater than 10 years (excluding diagnosis of breast cancer).

• Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria).

• On histologic examination, the tumor must be DCIS or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:

  1. sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
  2. axillary dissection (minimum of six axillary nodes removed); and
  3. the axillary node(s) must be pathologically negative.

• The T stage must be Tis, T1, or T2. If T2, the tumor must be ≤ 3.0 cm in maximum diameter.

• Estrogen receptor positive tumor

Exclusion Criteria

• Age < 50 at diagnosis (regardless of histology)
• Pregnant or breast-feeding (if appropriate, patient must use birth control during the study)
• Active collagen-vascular disease
• Paget's disease of the breast
• History of DCIS or invasive breast cancer
• Prior breast or thoracic RT for any condition
• Multicentric carcinoma (DCIS or invasive)
• Synchronous bilateral invasive or non-invasive breast cancer
• Surgical margins that cannot be microscopically assessed or that are positive or close
• Positive axillary node(s)
• T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage > 3
• Estrogen receptor negative tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Conture Multi-Lumen Balloon	Conture Multi-Lumen Balloon

Primary Outcome Measures

Name	Time	Method
Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.	5 years

Secondary Outcome Measures

Name	Time	Method
Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison.	5 years

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States