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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01008514
Recruitment Status : Withdrawn (funding issues and Principal Investigator leaving the institution)
First Posted : November 5, 2009
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

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.

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

Detailed Description:



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


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Proportion of local recurrence [ Time Frame: up to 5 years ]
    • 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 :
  1. Safety and toxicity [ Time Frame: up to 30 months after radiotherapy ]
  2. Cosmetic results [ Time Frame: up to 30 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01008514

Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
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Principal Investigator: Edward Kim, MD Ohio State University Comprehensive Cancer Center
Additional Information:
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Responsible Party: Ohio State University Comprehensive Cancer Center Identifier: NCT01008514    
Other Study ID Numbers: OSU-08177
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases