We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00090844
First Posted: September 8, 2004
Last Update Posted: January 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida
Results First Submitted: November 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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.  

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.  

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.  

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.  


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Triptorelin

GnRH analogue (triptorelin) during chemotherapy

triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection

no Triptorelin No GnRH analogue (triptorelin) during chemotherapy

Serious Adverse Events
    Triptorelin   no Triptorelin
Total, Serious Adverse Events     
# participants affected / at risk   2/27 (7.41%)   0/22 (0.00%) 
Infections and infestations     
Febrile Neutropenia †     
# participants affected / at risk   1/27 (3.70%)   0/22 (0.00%) 
# events   1   0 
Vascular disorders     
Thrombosis/thrombus/embolism †     
# participants affected / at risk   1/27 (3.70%)   0/22 (0.00%) 
# events   1   0 
Events were collected by systematic assessment




  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
Study closed to accrual early due to futility


  More Information