This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Mammosite Breast Brachytherapy Optimization in the Treatment of Breast Carcinoma (Mammosite)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00611624
First received: January 29, 2008
Last updated: April 10, 2017
Last verified: February 2017
Results First Received: July 25, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Neoplasms
Intervention: Radiation: Mammosite brachytherapy radiation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Five Days of Mammosite Therapy Five Days of Mammosite Therapy (Radiotherapy)

Participant Flow:   Overall Study
    Five Days of Mammosite Therapy
STARTED   28 
COMPLETED   28 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Five Days of Mammosite Therapy No text entered.

Baseline Measures
   Five Days of Mammosite Therapy 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 28 
<=18 years      0   0.0% 
Between 18 and 65 years      14  50.0% 
>=65 years      14  50.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 28 
Female      28 100.0% 
Male      0   0.0% 
Tumor Stage [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 28 
Tis      4  14.3% 
T1mi      1   3.6% 
T1a      2   7.1% 
T1b      10  35.7% 
T1c      11  39.3% 
[1] Breast cancer tumor size was determined prior to study inclusion. Tis is Carcinoma in situ. T1 tumors are 2 cm or smaller. T1mi is Tumor ≤ 1 0.1cm in greatest dimension. T1a - T1c is ordered smallest to largest (all under 2 cm).
Histology 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 28 
Ductal carcinoma in situ (DCIS)      4  14.3% 
Invasive ductal carcinoma      19  67.9% 
Invasive lobular carcinoma      3  10.7% 
Invasive tubulolobular carcinoma      1   3.6% 
Invasive cribriform carcinoma      1   3.6% 
Lymph node evaluation [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 24 
Sentinel lymph node      24 100.0% 
Axillary lymph node dissection      0   0.0% 
[1] Only those with invasive disease were counted.
[2] n = 24
Size of invasive component 
[Units: Centimeters (cm)]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 28 
   1.0 
 (0.1 to 2.0) 
Size of in situ component 
[Units: Centimeters (cm)]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 28 
   0.8 
 (0 to 2.8) 
Size of in situ component (DCIS patients) [1] 
[Units: Centimeters (cm)]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 4 
   0.8 
 (0.3 to 2.2) 
[1] This was only measured in DCIS patients (n=4).
estrogen receptor (ER) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 28 
positive      28 100.0% 
negative      0   0.0% 
progesterone receptor (PR) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 28 
positive      24  85.7% 
negative      4  14.3% 
HER2/neu status (invasive disease only) [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 24 
positive      0   0.0% 
negative      24 100.0% 
[1] Only counted in those with invasive disease (n=24).
lymphovascular space invasion (LVSI) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 28 
yes      0   0.0% 
no      28 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.   [ Time Frame: one year ]

2.  Secondary:   Information of Treatment Parameters in Order to Define Parameters Most Predictive of Skin Toxicity   [ Time Frame: Upon completion of study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kira F. Pavlik, CCRP Clinical Research Coordinator Therapeutic Radiology
Organization: Yale Comprehensive Cancer Center
phone: (203) 737-2587
e-mail: kira.pavlik@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00611624     History of Changes
Other Study ID Numbers: 0601000957
Study First Received: January 29, 2008
Results First Received: July 25, 2016
Last Updated: April 10, 2017