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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


Phase 4
50 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Douglas W. Arthur, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Institutional Review Board

Study ID:

SENORX-S07-002

NCT ID:

NCT00699101

Start Date:

June 2008

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Conture®
  • Brachytherapy
  • Breast Neoplasms

Name

Location

Virginia Commonwealth UniversityRichmond, Virginia