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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:
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
History of Changes
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
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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
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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  
Number of Participants  
[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 ]
  Show Outcome Measure 1

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
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Triptorelin     no Triptorelin  
Total, other (not including serious) adverse events      
# participants affected / at risk     25/27 (92.59%)     18/22 (81.82%)  
Blood and lymphatic system disorders      
Edema - limb †    
# participants affected / at risk     1/27 (3.70%)     2/22 (9.09%)  
# events     1     3  
Endocrine disorders      
hot flashes/flushes †    
# participants affected / at risk     23/27 (85.19%)     12/22 (54.55%)  
# events     38     18  
Gastrointestinal disorders      
Constipation †    
# participants affected / at risk     4/27 (14.81%)     2/22 (9.09%)  
# events     5     3  
Distension/bloating, abdominal †    
# participants affected / at risk     3/27 (11.11%)     1/22 (4.55%)  
# events     3     1  
Heartburn/dyspepsia †    
# participants affected / at risk     1/27 (3.70%)     3/22 (13.64%)  
# events     2     5  
Mucositis/stomatitis (clinical exam) †    
# participants affected / at risk     2/27 (7.41%)     1/22 (4.55%)  
# events     2     1  
Nausea †    
# participants affected / at risk     6/27 (22.22%)     7/22 (31.82%)  
# events     8     14  
Vomiting †    
# participants affected / at risk     2/27 (7.41%)     2/22 (9.09%)  
# events     2     2  
Mucositis/stomatitis (NOS) †    
# participants affected / at risk     0/27 (0.00%)     2/22 (9.09%)  
# events     0     2  
General disorders      
Fatigue †    
# participants affected / at risk     4/27 (14.81%)     1/22 (4.55%)  
# events     5     1  
Insomnia †    
# participants affected / at risk     3/27 (11.11%)     2/22 (9.09%)  
# events     3     2  
Sweating (diaphoresis) †    
# participants affected / at risk     4/27 (14.81%)     5/22 (22.73%)  
# events     4     6  
Weight gain †    
# participants affected / at risk     3/27 (11.11%)     1/22 (4.55%)  
# events     3     1  
Pain †    
# participants affected / at risk     10/27 (37.04%)     7/22 (31.82%)  
# events     31     16  
Headaches †    
# participants affected / at risk     6/27 (22.22%)     5/22 (22.73%)  
# events     13     5  
Pain - Other †    
# participants affected / at risk     2/27 (7.41%)     2/22 (9.09%)  
# events     2     2  
Infections and infestations      
Infection - Other †    
# participants affected / at risk     2/27 (7.41%)     2/22 (9.09%)  
# events     2     2  
Infection with unknown ANC †    
# participants affected / at risk     4/27 (14.81%)     4/22 (18.18%)  
# events     6     5  
Metabolism and nutrition disorders      
ALT, SGPT (serum glutamic pyruvic transaminase) †    
# participants affected / at risk     6/27 (22.22%)     5/22 (22.73%)  
# events     7     5  
AST, SGOT (serum glutamic oxaloacetic transaminase) †    
# participants affected / at risk     3/27 (11.11%)     3/22 (13.64%)  
# events     4     3  
Alkaline phosphatase †    
# participants affected / at risk     2/27 (7.41%)     0/22 (0.00%)  
# events     4     0  
Glucose, serum-high (hyperglycemia) †    
# participants affected / at risk     9/27 (33.33%)     8/22 (36.36%)  
# events     22     14  
Metabolic/Laboratory - Other †    
# participants affected / at risk     6/27 (22.22%)     0/22 (0.00%)  
# events     10     0  
Potassium, serum-low (hypokalemia) †    
# participants affected / at risk     3/27 (11.11%)     1/22 (4.55%)  
# events     3     1  
Nervous system disorders      
Mood alteration †    
# participants affected / at risk     13/27 (48.15%)     6/22 (27.27%)  
# events     15     8  
Neuropathy: sensory †    
# participants affected / at risk     2/27 (7.41%)     2/22 (9.09%)  
# events     2     2  
Reproductive system and breast disorders      
Vaginal dryness †    
# participants affected / at risk     3/27 (11.11%)     0/22 (0.00%)  
# events     3     0  
Vaginal discharge (non-infectious) †    
# participants affected / at risk     2/27 (7.41%)     0/22 (0.00%)  
# events     2     0  
Respiratory, thoracic and mediastinal disorders      
Cough †    
# participants affected / at risk     2/27 (7.41%)     0/22 (0.00%)  
# events     2     0  
Skin and subcutaneous tissue disorders      
Dermatology/Skin - Other †    
# participants affected / at risk     3/27 (11.11%)     1/22 (4.55%)  
# events     4     1  
Hair loss/alopecia (scalp or body) †    
# participants affected / at risk     11/27 (40.74%)     7/22 (31.82%)  
# events     11     7  
Ulceration †    
# participants affected / at risk     0/27 (0.00%)     2/22 (9.09%)  
# events     0     2  
† Events were collected by systematic assessment



  Limitations and Caveats
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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
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