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

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

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
Overall Participants Analyzed  [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

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 ]

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 ]

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 ]

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 ]

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

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