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The Treatment of T1N0 Invasive Breast Carcinoma by Local Excision and Interstitial Implant

Phase 1/Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

The Treatment of T1N0 Invasive Breast Carcinoma by Local Excision and Interstitial Implant

- When participants undergo surgery to remove the tumor (lumpectomy), it will be followed
by the placement of small flexible tubes throughout the region surrounding the site of
operation. These tubes will remain in place for 7-9 days following the surgery.

- The first 2-3 days, the tubes will not contain radioactivity. This time is used to do
all the calculations necessary for treatment and to check the findings in the breast
tissue that was removed. After 2-3 days, the tubes will be filled with a radioactive
wire which will remain in place for the next 5 days. During this period of time,
participants will be required to remain within the hospital. At the end of these 5
days, the radioactive wires and tubes will be removed.

Inclusion Criteria:

- Low risk of multifocal disease within the breast whose tumor location is favorable
for brachytherapy catheter placement

- Diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology)
and be clinical stage T1N0 (primary tumor < 2cm, clinically negative nodes)

- Location of primary tumor is not immediately adjacent to the nipple of chest wall

- No evidence of two or more separate tumors within the breast

- All histologic types and pathologic grades of primary tumor

- No extensive intraductal component (substantial intraductal carcinoma away from the
primary tumor location)

- No lymphatic or vascular invasion

- Lymph node staging by sentinel node excision or axillary dissection confirms node
negative status (If node positive, implant is used to deliver boost to tumor bed)

- Assessment of final surgical margins should be predominantly negative, but a single
small region of focal positivity is allowable as it is for whole breast radiation

- 18 years of age or older

Exclusion Criteria:

- Tumor is too close to the chest wall to allow placement of catheters

- Contraindications to radiation therapy are present, including a history of
scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or
prior chest wall radiation

Type of Study:


Study Design:

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

Outcome Measure:

To determine if interstitial implant brachytherapy to radical radiation doses is feasible following wide local excision of T1N0 breast carcinoma

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Alphonse Taghian, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

June 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • early stage invasive breast cancer
  • Partial breast irradiation
  • interstitial implant
  • Breast Neoplasms
  • Carcinoma



Massachusetts General Hospital Boston, Massachusetts  02114-2617