NCT00977275

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Jun 1997

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

8.9 years

First QC Date

September 11, 2009

Last Update Submit

April 7, 2017

Conditions

Breast Cancer

Keywords

early stage invasive breast cancerPartial breast irradiationinterstitial implant

Outcome Measures

Primary Outcomes (1)

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

    3 years

Interventions

Interstitial Implant BrachytherapyRADIATION

Via tubes placed at the time of wide local excision delivered over 5 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related 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-year outcomes from a prospective trial. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):791-800. doi: 10.1016/j.ijrobp.2011.09.003. Epub 2011 Nov 16.

    PMID: 22099046RESULT

  • 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 J Radiat Oncol Biol Phys. 2003 Jul 1;56(3):671-80. doi: 10.1016/s0360-3016(03)00071-3.

    PMID: 12788172RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alphonse Taghian, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Breast Radiation Oncology, MGH

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 15, 2009

Study Start

June 1, 1997

Primary Completion

May 1, 2006

Study Completion

May 1, 2013

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

US(1)