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:
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


  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 posted.   Anticipated Posting 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 posted.   Anticipated Posting 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 posted.   Anticipated Posting 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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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  


Results Point of Contact:  
Name/Title: Pamela Munster, MD
Organization: Division of Hematology & Oncology, University of California, San Francisco
phone: 415-476-1000
e-mail: Pmunster@medicine.ucsf.edu


No publications provided


Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00090844     History of Changes
Other Study ID Numbers: CDR0000374991, P30CA076292, MCC-0203, NCI-7031
Study First Received: September 7, 2004
Results First Received: November 30, 2012
Last Updated: January 23, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration