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 of 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 of 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 of 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 July 24, 2014