Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977275
• Other study ID #: 97-585
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 11, 2009
• Last updated: April 7, 2017
• Start date: June 1997
• Est. completion date: May 2013

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate radiation therapy directed to a small region of the breast in women who were recently diagnosed with early stage invasive breast cancer.

Description:

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2013
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Interstitial Implant Brachytherapy
Via tubes placed at the time of wide local excision delivered over 5 days

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hattangadi JA, Powell SN, MacDonald SM, Mauceri T, Ancukiewicz M, Freer P, Lawenda B, Alm El-Din MA, Gadd MA, Smith BL, Taghian AG. Accelerated partial breast irradiation with low-dose-rate interstitial implant brachytherapy after wide local excision: 12- — View Citation

Lawenda BD, Taghian AG, Kachnic LA, Hamdi H, Smith BL, Gadd MA, Mauceri T, Powell SN. Dose-volume analysis of radiotherapy for T1N0 invasive breast cancer treated by local excision and partial breast irradiation by low-dose-rate interstitial implant. Int — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if interstitial implant brachytherapy to radical radiation doses is feasible following wide local excision of T1N0 breast carcinoma		3 years