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

March 25, 2015 updated by: Ohio State University Comprehensive Cancer Center

A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)

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.

Study Overview

Status

Withdrawn

Conditions

Breast Cancer

Intervention / Treatment

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.

Study Type

Interventional

Phase

Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and toxicity Time Frame: up to 30 months after radiotherapy	up to 30 months after radiotherapy
Cosmetic results Time Frame: up to 30 months	up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

Principal Investigator: Edward Kim, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Jamesline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 4, 2009

First Submitted That Met QC Criteria