Treatment of T1N0 Invasive Breast Carcinoma by Local Exci... | NCT00977275

Studies
Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant

NCT00977275

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Apr 11, 2017Actual

Enrollment

45Actual

Phase

Phase 1Phase 2

Conditions

Breast Cancer

Interventions

Interstitial Implant Brachytherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1997

Primary Completion Date

May 2006Actual

Completion Date

May 2013Actual

First Submitted Date

Sep 11, 2009

First Submission Date that Met QC Criteria

Sep 11, 2009

First Posted Date

Sep 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2017

Last Update Posted Date

Apr 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Name	Type	Description	Arm Group Labels	Other Names
Interstitial Implant Brachytherapy	Radiation	Via tubes placed at the time of wide local excision delivered over 5 days

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Alphonse Taghian, MD, PhD	Massachusetts General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22099046	Result	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.
12788172

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases