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

Primary Purpose

Breast Cancer

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Conture Multi-Lumen Balloon

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Conture®, Brachytherapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Conture Multi-Lumen Balloon

Outcomes

Primary Outcome Measures

Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.

Secondary Outcome Measures

Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison.

Full Information

NCT ID

NCT00699101

First Posted

June 12, 2008

Last Updated

June 14, 2013

Sponsor

SenoRx, Inc.

Collaborators

C. R. Bard

1. Study Identification

Unique Protocol Identification Number

NCT00699101

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Terminated

Study Start Date

June 2008 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SenoRx, Inc.

Collaborators

C. R. Bard

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Conture®, Brachytherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

342 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Conture Multi-Lumen Balloon

Intervention Type

Device

Intervention Name(s)

Conture Multi-Lumen Balloon

Intervention Description

Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.

Primary Outcome Measure Information:

Title

Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or axillary dissection (minimum of six axillary nodes removed); and 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas W. Arthur, MD

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Study Chair

Facility Information:

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298-0058

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25442036

Citation

Cuttino LW, Arthur DW, Vicini F, Todor D, Julian T, Mukhopadhyay N. Long-term results from the Contura multilumen balloon breast brachytherapy catheter phase 4 registry trial. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1025-9. doi: 10.1016/j.ijrobp.2014.08.341. Epub 2014 Oct 13.

Results Reference

derived

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

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