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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
adjuvant therapy
accelerated partial breast irradiation
intracavitary balloon brachytherapy
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring ductal breast carcinoma in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Proportion of local recurrence
    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
    Cosmetic results

    Full Information

    First Posted
    November 4, 2009
    Last Updated
    March 25, 2015
    Sponsor
    Ohio State University Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01008514
    Brief Title
    Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer
    Official Title
    A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    funding issues and Principal Investigator leaving the institution
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ohio State University Comprehensive Cancer Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    ductal breast carcinoma in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    adjuvant therapy
    Intervention Type
    Radiation
    Intervention Name(s)
    accelerated partial breast irradiation
    Intervention Type
    Radiation
    Intervention Name(s)
    intracavitary balloon brachytherapy
    Primary Outcome Measure Information:
    Title
    Proportion of local recurrence
    Description
    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.
    Time Frame
    up to 5 years
    Secondary Outcome Measure Information:
    Title
    Safety and toxicity
    Time Frame
    up to 30 months after radiotherapy
    Title
    Cosmetic results
    Time Frame
    up to 30 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edward Kim, MD
    Organizational Affiliation
    Ohio State University Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://cancer.osu.edu
    Description
    Jamesline

    Learn more about this trial

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

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