Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer

This study has been terminated.
(Early closure due to low accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00090844
First received: September 7, 2004
Last updated: January 23, 2013
Last verified: January 2013
Results First Received: November 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Hormone Changes
Drug Toxicity
Intervention: Drug: triptorelin

  Participant Flow


  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
Triptorelin GnRH analogue (triptorelin) during chemotherapy
no Triptorelin no GnRH analogue (triptorelin) during chemotherapy
Total Total of all reporting groups

Baseline Measures
   Triptorelin   no Triptorelin   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   22   49 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   27   22   49 
>=65 years   0   0   0 
Age 
[Units: Years]
Median (Full Range)
 39 
 (21 to 44) 
 38 
 (26 to 44) 
 39 
 (21 to 44) 
Gender 
[Units: Participants]
     
Female   27   22   49 
Male   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   3   2   5 
Not Hispanic or Latino   24   20   44 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   2   2 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   2   1   3 
White   25   19   44 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   27   22   49 


  Outcome Measures

1.  Primary:   Time to Resumption of Menses   [ Time Frame: Baseline, end of chemotherapy then 5 years ]

2.  Secondary:   Chemotherapy-related Amenorrhea   [ Time Frame: Baseline, end of chemotherapy then 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Alternative Markers of Ovarian Failure as Assessed by Inhibin A and Inhibin B Every 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years   [ Time Frame: Baseline, end of chemotherapy then 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Quality of Life as Assessed by FACT-ES Monthly During Treatment, Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years   [ Time Frame: Baseline, through chemotherapy then 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Disease-free Survival Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years   [ Time Frame: 5 years after end of chemotherapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information