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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01008514
• Other study ID #: OSU-08177
• Status: Withdrawn
• Phase: Phase 2
• First received: November 4, 2009
• Last updated: March 25, 2015

Study information

• Verified date: March 2015
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• adjuvant therapy

Radiation:
• accelerated partial breast irradiation

• intracavitary balloon brachytherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 5 years	No
Secondary	Safety and toxicity		up to 30 months after radiotherapy	Yes
Secondary	Cosmetic results		up to 30 months	No

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