Use of the Contura™ Catheter to Deliver Accelerated Partial Breast Irradiation to Low-risk Breast Cancer Patients

A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00882596

Enrollment

Registered

2009-04-16

Start date

2008-05-31

Completion date

2013-07-31

Last updated

2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Contura, Cancer, Accelerated, Partial, Breast, Irradiation

Brief summary

The purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.

Detailed description

The Cancer Center of Irvine is one of the busiest centers in the United States for Contura accelerated partial breast irradiation.

Interventions

DEVICEAccelerated partial breast irradiation

A total radiation dose of 34 Gy is delivered in 10 fractions bid over 5-7 days with 6 hours between the radiation treatments each day. Each radiation treatment takes 15-30 minutes. There is no radioactivity left behind in the patient.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to No maximum

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 and/or invasive breast carcinoma * For patients with invasive breast cancer, an axillary staging procedure must be performed \[either sentinel node biopsy or axillary dissection (with a minimum of 6 axillary nodes removed), and the axillary node(s) must be pathologically negative\] * The T stage must be Tis, T1, or T2. If T2, the tumor must be less than or equal to 3.0 cm in maximum diameter * Estrogen receptor positive tumor

Exclusion criteria

* Age \< 50 at diagnosis (regardless of histology) * Pregnant or breast-feeding * Active collagen vascular disease * Paget's disease of the breast * Prior history of DCIS or invasive breast cancer * Prior breast or thoracic radiation therapy 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 * Positive axillary node(s) * T stage of T2 with the tumor \> 3 cm in maximum diameter or a T stage of T3 or T4 * Estrogen receptor negative tumor

Design outcomes

Primary

Measure	Time frame
Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.	19 months

Secondary

Measure	Time frame
Toxicity rates	79 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026