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

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ClinicalTrials.gov Identifier: NCT00090844
Recruitment Status : Terminated (Early closure due to low accrual)
First Posted : September 8, 2004
Results First Posted : January 21, 2013
Last Update Posted : January 31, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida

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
Enrollment 49

Recruitment Details 49 female patients were enrolled between July 2003 and January 2007.
Pre-assignment Details  
Arm/Group Title Triptorelin no Triptorelin
Hide Arm/Group Description

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

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

No Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy
Period Title: Overall Study
Started 27 22
Completed 26 21
Not Completed 1 1
Arm/Group Title Triptorelin no Triptorelin Total
Hide Arm/Group Description GnRH analogue (triptorelin) during chemotherapy no GnRH analogue (triptorelin) during chemotherapy Total of all reporting groups
Overall Number of Baseline Participants 27 22 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 22 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
22
 100.0%
49
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants 22 participants 49 participants
39
(21 to 44)
38
(26 to 44)
39
(21 to 44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 22 participants 49 participants
Female
27
 100.0%
22
 100.0%
49
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 22 participants 49 participants
Hispanic or Latino
3
  11.1%
2
   9.1%
5
  10.2%
Not Hispanic or Latino
24
  88.9%
20
  90.9%
44
  89.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 22 participants 49 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   9.1%
2
   4.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   7.4%
1
   4.5%
3
   6.1%
White
25
  92.6%
19
  86.4%
44
  89.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 22 participants 49 participants
27 22 49
1.Primary Outcome
Title Time to Resumption of Menses
Hide Description Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triptorelin no Triptorelin
Hide Arm/Group Description:

GnRH analogue (triptorelin) during chemotherapy

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

No GnRH analogue (triptorelin) during chemotherapy
Overall Number of Participants Analyzed 26 21
Median (Full Range)
Unit of Measure: months
4.96
(.43 to 28)
5.82
(1.15 to 19)
2.Secondary Outcome
Title Chemotherapy-related Amenorrhea
Hide Description Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment. Record of menses is completed by patient throughout their time on study through chemotherapy and for 5 years.
Time Frame Baseline, end of chemotherapy then 5 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 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
Hide Description Inhibin A & inhibin B are collected at baseline, end of chemotherapy, then every 6 months for 2 years then annually for 3 more years. Inhibin A & Inhibin B are markers of ovarian failure.
Time Frame Baseline, end of chemotherapy then 5 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title 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
Hide Description FACT-ES (v4/4a) quality of life validated tool combines 18 item endocrine subscale (ES) with standardized breast cancer quality of life measure. Administered 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
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Disease-free Survival Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years
Hide Description Every 6 months for 2 years then annual for 3 more years. Patients will be seen, laboratory specimens will be drawn. Menses records will be collected and reviewed. Concomitant medications will be updated.
Time Frame 5 years after end of chemotherapy
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Triptorelin no Triptorelin
Hide Arm/Group Description

GnRH analogue (triptorelin) during chemotherapy

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

No GnRH analogue (triptorelin) during chemotherapy
All-Cause Mortality
Triptorelin no Triptorelin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Triptorelin no Triptorelin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/27 (7.41%)      0/22 (0.00%)    
Infections and infestations     
Febrile Neutropenia   1/27 (3.70%)  1 0/22 (0.00%)  0
Vascular disorders     
Thrombosis/thrombus/embolism   1/27 (3.70%)  1 0/22 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Triptorelin no Triptorelin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/27 (92.59%)      18/22 (81.82%)    
Blood and lymphatic system disorders     
Edema - limb   1/27 (3.70%)  1 2/22 (9.09%)  3
Endocrine disorders     
hot flashes/flushes   23/27 (85.19%)  38 12/22 (54.55%)  18
Gastrointestinal disorders     
Constipation   4/27 (14.81%)  5 2/22 (9.09%)  3
Distension/bloating, abdominal   3/27 (11.11%)  3 1/22 (4.55%)  1
Heartburn/dyspepsia   1/27 (3.70%)  2 3/22 (13.64%)  5
Mucositis/stomatitis (clinical exam)   2/27 (7.41%)  2 1/22 (4.55%)  1
Nausea   6/27 (22.22%)  8 7/22 (31.82%)  14
Vomiting   2/27 (7.41%)  2 2/22 (9.09%)  2
Mucositis/stomatitis (NOS)   0/27 (0.00%)  0 2/22 (9.09%)  2
General disorders     
Fatigue   4/27 (14.81%)  5 1/22 (4.55%)  1
Insomnia   3/27 (11.11%)  3 2/22 (9.09%)  2
Sweating (diaphoresis)   4/27 (14.81%)  4 5/22 (22.73%)  6
Weight gain   3/27 (11.11%)  3 1/22 (4.55%)  1
Pain   10/27 (37.04%)  31 7/22 (31.82%)  16
Headaches   6/27 (22.22%)  13 5/22 (22.73%)  5
Pain - Other   2/27 (7.41%)  2 2/22 (9.09%)  2
Infections and infestations     
Infection - Other   2/27 (7.41%)  2 2/22 (9.09%)  2
Infection with unknown ANC   4/27 (14.81%)  6 4/22 (18.18%)  5
Metabolism and nutrition disorders     
ALT, SGPT (serum glutamic pyruvic transaminase)   6/27 (22.22%)  7 5/22 (22.73%)  5
AST, SGOT (serum glutamic oxaloacetic transaminase)   3/27 (11.11%)  4 3/22 (13.64%)  3
Alkaline phosphatase   2/27 (7.41%)  4 0/22 (0.00%)  0
Glucose, serum-high (hyperglycemia)   9/27 (33.33%)  22 8/22 (36.36%)  14
Metabolic/Laboratory - Other   6/27 (22.22%)  10 0/22 (0.00%)  0
Potassium, serum-low (hypokalemia)   3/27 (11.11%)  3 1/22 (4.55%)  1
Nervous system disorders     
Mood alteration   13/27 (48.15%)  15 6/22 (27.27%)  8
Neuropathy: sensory   2/27 (7.41%)  2 2/22 (9.09%)  2
Reproductive system and breast disorders     
Vaginal dryness   3/27 (11.11%)  3 0/22 (0.00%)  0
Vaginal discharge (non-infectious)   2/27 (7.41%)  2 0/22 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough   2/27 (7.41%)  2 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other   3/27 (11.11%)  4 1/22 (4.55%)  1
Hair loss/alopecia (scalp or body)   11/27 (40.74%)  11 7/22 (31.82%)  7
Ulceration   0/27 (0.00%)  0 2/22 (9.09%)  2
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Pamela Munster, MD
Organization: Division of Hematology & Oncology, University of California, San Francisco
Phone: 415-476-1000
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00090844     History of Changes
Other Study ID Numbers: CDR0000374991
P30CA076292 ( U.S. NIH Grant/Contract )
MCC-0203 ( Other Identifier: Moffitt CCOP Research Base )
NCI-7031 ( Other Identifier: National Cancer Institute Division of Cancer Prevention )
First Submitted: September 7, 2004
First Posted: September 8, 2004
Results First Submitted: November 30, 2012
Results First Posted: January 21, 2013
Last Update Posted: January 31, 2013