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

NCT ID: NCT00699101

Last Updated: 2013-06-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Conture Multi-Lumen Balloon

Group Type: EXPERIMENTAL

Conture Multi-Lumen Balloon

Intervention Type: DEVICE

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

Interventions

Conture Multi-Lumen Balloon

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

Intervention Type: DEVICE

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:

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: collaborator

SenoRx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas W. Arthur, MD

Role: STUDY_CHAIR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25442036 (View on PubMed)

Other Identifiers

SENORX-S07-002

Identifier Type: -

Identifier Source: org_study_id