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Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml® Radiation Therapy Delivery System as the Sole Method of Radiation Therapy or as a Boost for Early Stage Breast Cancer and Ductal Carcinoma In Situ of the Breast


Phase 4
45 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Ductal Carcinoma in Situ

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Trial Information

Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml® Radiation Therapy Delivery System as the Sole Method of Radiation Therapy or as a Boost for Early Stage Breast Cancer and Ductal Carcinoma In Situ of the Breast


Inclusion Criteria:



- Women,age of at least 45 years

- Zubrod performance status of 0-2

- AJCC Stage I-II (T1-T2, N0 M0) breast cancer

- Maximum tumor dimension < 3 cm

- Invasive ductal, medullary, papillary, tubular, colloid (mucinous) histologies

- Unifocal breast cancer

- Unilateral breast cancer (no synchronous or previous contralateral breast cancer)

- Lumpectomy with negative surgical margins by at least 2 mm or re-excision specimen
with negative surgical margins by at least 2 mm

- Ductal Carcinoma In-Situ

- Negative axillary lymph nodes for invasive breast cancer (sentinel node biopsy or
standard level I-II dissection with > 6 nodes removed)

- Time interval from final breast surgery to brachytherapy loading less than 8 weeks

- At least 2 mm of breast tissue between the skin and the MammoSite® balloon
surface(prefer > 5 mm)

- If chemotherapy is planned, it must begin no earlier that 2 weeks following
completion of radiation therapy. If chemotherapy is first, a minimum of 2 weeks from
the last cycle must elapse prior to the start of radiation therapy.

- Signed study-specific consent form

Exclusion Criteria:

- Invasive lobular histology

- Non-epithelial breast malignancies such as sarcoma or lymphoma

- Multifocal or multicentric invasive carcinoma

- Extensive intraductal component (EIC)

- Paget's disease of the nipple

- Skin involvement by tumor, regardless of tumor size

- Positive axillary lymph nodes

- Distant metastases

- Collagen vascular disease (scleroderma)

- Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown
effects of RT on lactating females (negative pregnancy test for women of
child-bearing age)

- Any previously treated or synchronous contralateral breast carcinoma

- Patients with psychiatric or addictive disorder that would preclude obtaining
informed Consent

- Men

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

ipsilateral recurrence rate

Outcome Description:

Local recurrence is defined as either invasive or non-invasive breast cancer recurrence within the target volume. Elsewhere recurrence is defined as either invasive or non-invasive breast cancer recurrence outside of the target volume. Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Bethany G Sleckman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mercy Hospital St. Louis

Authority:

United States: Institutional Review Board

Study ID:

Mammosite ML

NCT ID:

NCT01448447

Start Date:

December 2009

Completion Date:

December 2017

Related Keywords:

  • Breast Cancer
  • Ductal Carcinoma In Situ
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location

Mercy Hospital St. LouisSt. Louis, Missouri  63141
Mercy Clinic St. Louis Cancer and Breast InstituteSt. Louis, Missouri  63011