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Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer

This study is not yet open for participant recruitment.
Verified February 2011 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01008514
First received: November 4, 2009
Last updated: May 25, 2011
Last verified: February 2011
History of Changes
  Purpose

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of local recurrence at 5 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and toxicity [ Designated as safety issue: Yes ]
  • Cosmetic results as assessed at baseline, 6 months, and 30 months [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering partial-breast irradiation to women with early-stage breast cancer.

Secondary

  • To assess the toxicities associated with MammoSite® RTS in these patients.
  • To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite® RTS.
  • To correlate the cosmetic results with the use of chemotherapy, volume of the implant, and distance from the implant to the skin.
  • To correlate the local recurrence rate with time between surgery and implant.

OUTLINE: Patients undergo placement of the MammoSite® Radiation Therapy System (RTS) device into the cavity where the tumor was removed either at the time of surgery or percutaneously under ultrasound guidance after surgery. Within 2-5 days after the device implant, patients undergo partial-breast irradiation delivered by MammoSite® RTS twice daily for 5 days.

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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ (DCIS) of the breast or invasive breast adenocarcinoma

    • Stage 0, I, or II (T2, N0; tumor size ≤ 3 cm) disease

    • Pathologic staging of the axilla preferred

      • Clinical staging of the axilla allowed for patients ≥ 70 years of age with hormone receptor-positive tumors

  • Unicentric tumor

    • Microscopic multifocality allowed as long as the total tumor size is ≤ 3 cm

  • Must have undergone lumpectomy as definitive surgery

    • Negative surgical margins, defined as no tumor at the inked margin of resection after final surgery

      • Re-excision to obtain negative margins allowed
  • Must have adequate skin spacing between balloon surface and surface of the skin and lung (≥ 7 mm)
  • No multicentric carcinoma (invasive or DCIS) in more than one quadrant
  • No clinically or pathologically positive regional lymph nodes
  • No extensive intraductal component, defined as DCIS extending beyond the primary invasive component into normal breast parenchyma and composing > 25% of the primary tumor
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

  • No collagen-vascular disease, including any of the following:

    • Dermatomyositis
    • Systemic lupus erythematosus
    • Scleroderma-mixed connective tissue disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008514

Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Edward Kim, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Edward Kim, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01008514     History of Changes
Other Study ID Numbers: CDR0000651359, OSU-08177, 2009C0041
Study First Received: November 4, 2009
Last Updated: May 25, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ
stage IA breast cancer
stage IB 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 June 18, 2013