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

This study has been withdrawn prior to enrollment.
(funding issues and Principal Investigator leaving the institution)
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01008514
First received: November 4, 2009
Last updated: March 25, 2015
Last verified: March 2015
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Proportion of local recurrence [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    • Local recurrence is defined as either invasive or non-invasive local recurrence within the target volume.
    • Ipsilateral elsewhere recurrence is defined as either invasive or non-invasive local recurrence outside of the target volume.


Secondary Outcome Measures:
  • Safety and toxicity [ Time Frame: up to 30 months after radiotherapy ] [ Designated as safety issue: Yes ]
  • Cosmetic results [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]

Enrollment: 0
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   (Adult, Senior)
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
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: NCT01008514

Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Edward Kim, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01008514     History of Changes
Other Study ID Numbers: OSU-08177 
Study First Received: November 4, 2009
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
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 July 28, 2016