Use of the Contura™ Catheter in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients

NCT00882089 | Completed Phase 4 DMC

• 1 other identifier: 1098987
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a Contura catheter can avoid a radiation "hot spot" in the skin and improve tissue-balloon conformance in early-stage breast cancer patients undergoing accelerated partial breast irradiation.

Conditions

Breast Cancer

Keywords

Contura; Cancer; Accelerated; Partial; Breast; Irradiation

Outcome Measures

Primary Outcomes (1)

• Maximum skin dose is less than or equal to 100% of the prescribed radiation dose and air/fluid pocket next to the balloon is less than or equal to 3.0% of the planning target volume for plan evaluation

  19 months

Secondary Outcomes (1)

• Number of cases where the balloon catheter has to be explanted when the balloon-to-skin spacing is only 3-6 mm.

  19 months

Study Arms (1)

1

EXPERIMENTAL

A Contura balloon catheter is placed in the lumpectomy cavity. Later that morning, accelerated partial irradiation begins.

Device: Contura catheter

Interventions

Contura catheter DEVICE

Radiation therapy is delivered to a total dose of 34 Gy in 10 fractions bid over 5-7 days. Each day, the high dose rate iridium-192 brachytherapy treatments are separated by 6 hours. Each radiation treatment takes 15-30 minutes.

Also known as: Contura Multi-Lumen Balloon Applicator

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative or axillary dissection or sampling with a minimum total of 6 axillary nodes if sentinel node is positive. Axillary staging is not required for patients with DCIS.
• Estrogen receptor (ER) and progesterone receptor (PR) analysis must be negative.
• The patient must be ≥ 18 years old.
• If the patient is older than 49 years, she must meet at least one of the following 2 conditions:
• i. 1-3 histologically positive axillary nodes ii. negative ER and PR analysis
• The patient should have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer.
• The tumor must be DCIS or invasive adenocarcinoma of the breast.
• Gross disease must be unifocal with pathologic tumor size 3.0 cm or less. Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3.0 cm or less.
• The patient must have pathological stage 0, I, or II breast cancer.
• Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive). Re-excision of surgical margins is permitted.
• The patient must be registered within 42 days following the last surgery for breast cancer.
• The target lumpectomy cavity/whole breast reference volume must be ≤ 30% based on the postoperative CT scan.

You may not qualify if:

• The patient is \< 18 years old.
• If the patient is older than 49 years, she has both an ER and PR positive tumor and histologically negative axillary nodes.
• T2 (\> 3.0 cm), T3, stage III, or stage IV breast cancer.
• "Marginal" or "borderline" ER or PR analysis results.
• More than 3 histologically positive axillary nodes.
• Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.
• One or more positive non-axillary sentinel node(s). Intramammary nodes are staged as axillary nodes.
• Non-epithelial breast malignancies such as sarcoma or lymphoma.
• Proven multicentric carcinoma in more than one quadrant or separated by 4 or more centimeters.
• Paget's disease of the nipple.
• Synchronous bilateral invasive or non-invasive breast cancer.
• History of DCIS or invasive breast cancer.
• Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
• Clear delineation of the target lumpectomy cavity not possible.
• Any treatment with radiation therapy, chemotherapy, and/or biotherapy administered for the currently diagnosed breast cancer prior to registration. The only exception is hormonal therapy, which may have been given for no more than a total of 28 days anytime after diagnosis and before registration.

Sponsors & Collaborators

• Cancer Center of Irvine: lead
• SenoRx, Inc.: collaborator

Study Sites (1)

Cancer Center of Irvine

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Richard B Wilder, MD

  Cancer Center of Irvine

  PRINCIPAL INVESTIGATOR

• Kenneth M Tokita, MD

  Cancer Center of Irvine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: October 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 25, 2018

Record last verified: 2013-07

Locations

US (1)