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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
  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
49 female patients were enrolled between July 2003 and January 2007.

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
Triptorelin

Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy

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

no Triptorelin No Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy

Participant Flow:   Overall Study
    Triptorelin   no Triptorelin
STARTED   27   22 
COMPLETED   26   21 
NOT COMPLETED   1   1 



  Baseline Characteristics


  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


  Other Adverse Events


  Limitations and Caveats


  More Information