Internal Radiation Therapy of the Breast in Treating Women With Early-Stage Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
SenoRx, Inc.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier:
NCT01019720
First received: November 24, 2009
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy through a special catheter that is placed in the breast may kill any tumor cells that remain after surgery. It may also be an effective treatment for breast cancer.

PURPOSE: This phase II trial is studying how well internal radiation therapy given through a special catheter works in treating women with early-stage breast cancer.


Condition Intervention Phase
Breast Cancer
Radiation: accelerated partial breast irradiation
Radiation: intracavitary balloon brachytherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Short-course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Locoregional failure rate at 3 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity rates (in-breast and non-breast complication rates) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Cosmesis at 3 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiotherapy Radiation: accelerated partial breast irradiation

This multiple site, prospective, non-randomized dose escalation study has been designed to determine the safety and feasibility of delivering accelerated partial breast irradiation (APBI)with the Contura™ MLB balloon catheter in a short course, 2 day fashion.

Dose Level 1 - 7 Gy X 4 Dose Level 2 - 8.25 Gy X 3 Dose Level 3 - 10.25 X 2

Radiation: intracavitary balloon brachytherapy
The Contura MLB balloon catheter is used to position tissue and radioactive sources during breast brachytherapy treatments.

Detailed Description:

OBJECTIVES:

Primary

  • To determine local disease control in women with early-stage breast cancer treated with shorter courses of accelerated partial-breast radiotherapy (APBI) delivered with a breast brachytherapy applicator.

Secondary

  • To determine whether the acceptable toxicity rates of APBI can be preserved when further accelerating the dose delivery scheme from the commonly applied ten treatments delivered twice daily over 5 days to two treatments delivered over 2 days.
  • To assess the rate of excellent or good cosmesis at 3 years after shorter courses of APBI.
  • To identify covariants associated with and predictive of poor cosmetic outcome in patients treated with an overnight course of APBI.

OUTLINE: This is a multicenter study.

Patients undergo placement of the Contura™ MLB device into the lumpectomy cavity followed by CT scan for treatment planning. Approximately 1-5 days after balloon placement, patients undergo accelerated partial-breast radiotherapy twice daily over 2 days.

After completion of study therapy, patients are followed up periodically for 5 years.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ (DCIS) and/or invasive breast cancer

    • Stage Tis, T1, or T2 disease

      • T2 tumor must be ≤ 3.0 cm in maximum diameter
  • Must have undergone lumpectomy as surgical treatment of the breast

    • Negative surgical margins by histology per NSABP criteria

      • No surgical margins that cannot be microscopically assessed
    • Patients with invasive breast cancer must have undergone an axillary staging procedure by sentinel node biopsy alone or axillary dissection (with ≥ 6 axillary nodes removed)

      • Axillary node(s) must be pathologically negative
  • No Paget disease of the breast
  • No prior DCIS or invasive breast cancer
  • No multicentric carcinoma (DCIS or invasive)
  • No synchronous bilateral invasive or non-invasive breast cancer
  • Hormone-receptor status meeting 1 of the following criteria:

    • Estrogen receptor (ER) positive tumor
    • ER negative and progesterone receptor positive tumor

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Life expectancy > 10 years (excluding diagnosis of breast cancer)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active collagen vascular disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior breast or thoracic radiotherapy for any condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019720

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
SenoRx, Inc.
Investigators
Principal Investigator: Atif Khan, MD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier: NCT01019720     History of Changes
Other Study ID Numbers: 040902, CDR0000660027, S09-001, P30CA072720
Study First Received: November 24, 2009
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
ductal breast carcinoma in situ
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014