Trial Outcomes & Findings for Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer (NCT NCT00090844)
NCT ID: NCT00090844
Last Updated: 2021-01-28
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Baseline, end of chemotherapy then 5 years
Results posted on
2021-01-28
Participant Flow
49 female patients were enrolled between July 2003 and January 2007.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
22
|
|
Overall Study
COMPLETED
|
26
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
Baseline characteristics by cohort
| Measure |
Triptorelin
n=27 Participants
GnRH analogue (triptorelin) during chemotherapy
|
no Triptorelin
n=22 Participants
no GnRH analogue (triptorelin) during chemotherapy
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39 years
n=5 Participants
|
38 years
n=7 Participants
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
22 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, end of chemotherapy then 5 yearsOvarian 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
Outcome measures
| Measure |
Triptorelin
n=26 Participants
GnRH analogue (triptorelin) during chemotherapy
triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
|
no Triptorelin
n=21 Participants
No GnRH analogue (triptorelin) during chemotherapy
|
|---|---|---|
|
Time to Resumption of Menses
|
4.96 months
Interval 0.43 to 28.0
|
5.82 months
Interval 1.15 to 19.0
|
SECONDARY outcome
Timeframe: Baseline, end of chemotherapy then 5 yearsChemotherapy-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.
Outcome measures
| Measure |
Triptorelin
n=26 Participants
GnRH analogue (triptorelin) during chemotherapy
triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
|
no Triptorelin
n=21 Participants
No GnRH analogue (triptorelin) during chemotherapy
|
|---|---|---|
|
Chemotherapy-related Amenorrhea
|
3 Participants
|
2 Participants
|
Adverse Events
Triptorelin
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
no Triptorelin
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triptorelin
n=27 participants at risk
GnRH analogue (triptorelin) during chemotherapy
triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
|
no Triptorelin
n=22 participants at risk
No GnRH analogue (triptorelin) during chemotherapy
|
|---|---|---|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.7%
1/27 • Number of events 1
|
0.00%
0/22
|
|
Infections and infestations
Febrile Neutropenia
|
3.7%
1/27 • Number of events 1
|
0.00%
0/22
|
Other adverse events
| Measure |
Triptorelin
n=27 participants at risk
GnRH analogue (triptorelin) during chemotherapy
triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
|
no Triptorelin
n=22 participants at risk
No GnRH analogue (triptorelin) during chemotherapy
|
|---|---|---|
|
General disorders
Fatigue
|
14.8%
4/27 • Number of events 5
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Insomnia
|
11.1%
3/27 • Number of events 3
|
9.1%
2/22 • Number of events 2
|
|
General disorders
Sweating (diaphoresis)
|
14.8%
4/27 • Number of events 4
|
22.7%
5/22 • Number of events 6
|
|
General disorders
Weight gain
|
11.1%
3/27 • Number of events 3
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
11.1%
3/27 • Number of events 4
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
40.7%
11/27 • Number of events 11
|
31.8%
7/22 • Number of events 7
|
|
Endocrine disorders
hot flashes/flushes
|
85.2%
23/27 • Number of events 38
|
54.5%
12/22 • Number of events 18
|
|
Gastrointestinal disorders
Constipation
|
14.8%
4/27 • Number of events 5
|
9.1%
2/22 • Number of events 3
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
11.1%
3/27 • Number of events 3
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
3.7%
1/27 • Number of events 2
|
13.6%
3/22 • Number of events 5
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
7.4%
2/27 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
22.2%
6/27 • Number of events 8
|
31.8%
7/22 • Number of events 14
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
|
Infections and infestations
Infection - Other
|
7.4%
2/27 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
|
Blood and lymphatic system disorders
Edema - limb
|
3.7%
1/27 • Number of events 1
|
9.1%
2/22 • Number of events 3
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
22.2%
6/27 • Number of events 7
|
22.7%
5/22 • Number of events 5
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
11.1%
3/27 • Number of events 4
|
13.6%
3/22 • Number of events 3
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
7.4%
2/27 • Number of events 4
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
33.3%
9/27 • Number of events 22
|
36.4%
8/22 • Number of events 14
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
22.2%
6/27 • Number of events 10
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
11.1%
3/27 • Number of events 3
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Mood alteration
|
48.1%
13/27 • Number of events 15
|
27.3%
6/22 • Number of events 8
|
|
Nervous system disorders
Neuropathy: sensory
|
7.4%
2/27 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
|
General disorders
Pain
|
37.0%
10/27 • Number of events 31
|
31.8%
7/22 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • Number of events 2
|
0.00%
0/22
|
|
Reproductive system and breast disorders
Vaginal dryness
|
11.1%
3/27 • Number of events 3
|
0.00%
0/22
|
|
Reproductive system and breast disorders
Vaginal discharge (non-infectious)
|
7.4%
2/27 • Number of events 2
|
0.00%
0/22
|
|
General disorders
Headaches
|
22.2%
6/27 • Number of events 13
|
22.7%
5/22 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/27
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis/stomatitis (NOS)
|
0.00%
0/27
|
9.1%
2/22 • Number of events 2
|
|
Infections and infestations
Infection with unknown ANC
|
14.8%
4/27 • Number of events 6
|
18.2%
4/22 • Number of events 5
|
|
General disorders
Pain - Other
|
7.4%
2/27 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
Additional Information
Pamela Munster, MD
Division of Hematology & Oncology, University of California, San Francisco
Phone: 415-476-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place