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

Breast Cancer Clinical Trial

Official title:

A Multi-site Prospective, Non Randomized Study Utilizing the Conture® Multi-Lumen Balloon (MLB) Breast Brachytherapy Applicator to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetric Success, Local Tumor Control, Cosmetic Outcome, Acute and Chronic Toxicity, and Clinical Scenarios for Optimal Use

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00699101
• Other study ID #: SENORX-S07-002
• Status: Terminated
• Phase: Phase 4
• First received: June 12, 2008
• Last updated: June 14, 2013
• Start date: June 2008
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: SenoRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 342
• Est. completion date: June 2013
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Conture Multi-Lumen Balloon
Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
SenoRx, Inc.	C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.		5 years	No
Secondary	Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison.		5 years	No