Trial Outcomes & Findings for S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer (NCT NCT00068601)

NCT ID: NCT00068601

Last Updated: 2019-12-30

Results Overview

Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 257 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2019-12-30

Participant Flow

Participant milestones

Measure	Standard Chemotherapy Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen	Chemotherapy Plus Goserelin Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously
Overall Study STARTED	131	126
Overall Study COMPLETED	69	66
Overall Study NOT COMPLETED	62	60

Reasons for withdrawal

Measure	Standard Chemotherapy Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen	Chemotherapy Plus Goserelin Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously
Overall Study Ineligible	11	13
Overall Study Not evaluable: withdrew consent	5	4
Overall Study Not evaluable: hysterectomy/oophorectomy	2	4
Overall Study Death	11	3
Overall Study Lost to Follow-up	3	2
Overall Study Missing primary outcome data	30	34

Baseline Characteristics

S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

Baseline characteristics by cohort

Measure	Arm 1 n=113 Participants Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen	Arm 2 n=105 Participants Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously	Total n=218 Participants Total of all reporting groups
Age, Continuous	38.7 years n=5 Participants	37.6 years n=7 Participants	37.7 years n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	105 Participants n=7 Participants	218 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Patients who completed the study

Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.

Outcome measures

Measure	Standard Chemotherapy n=69 Participants Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen	Chemotherapy Plus Goserelin n=66 Participants Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously
Rate of Premature Ovarian Failure at 2 Years	15 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 2

Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.

Outcome measures

Measure	Standard Chemotherapy n=67 Participants Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen	Chemotherapy Plus Goserelin n=63 Participants Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously
Rate of Ovarian Dysfunction at 2 Years	22 Participants	9 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 1

Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.

Outcome measures

Measure	Standard Chemotherapy n=75 Participants Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen	Chemotherapy Plus Goserelin n=78 Participants Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen goserelin acetate: Given subcutaneously
Rate of Ovarian Dysfunction at 1 Year	28 Participants	18 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 and 2 years

Measurements of ovarian reserve will consist of "Day 2 - 4" levels of FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic, anytime during Month 12/13 and Month 24/25).

Outcome measures

Outcome data not reported

Adverse Events

Standard Chemotherapy

Serious events: 0 serious events

Other events: 70 other events

Deaths: 0 deaths

Chemotherapy Plus Goserelin

Serious events: 1 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Chemotherapy n=111 participants at risk Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen	Chemotherapy Plus Goserelin n=103 participants at risk Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen. goserelin acetate: Given subcutaneously
Vascular disorders Thrombosis/thrombus/embolism	0.00% 0/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	0.97% 1/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.

Other adverse events

Measure	Standard Chemotherapy n=111 participants at risk Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen	Chemotherapy Plus Goserelin n=103 participants at risk Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen. goserelin acetate: Given subcutaneously
Gastrointestinal disorders Nausea	8.1% 9/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	4.9% 5/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
General disorders Fatigue (asthenia, lethargy, malaise)	9.0% 10/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	7.8% 8/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
Musculoskeletal and connective tissue disorders Osteoporosis	8.1% 9/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	0.97% 1/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
Nervous system disorders Pain - Head/headache	32.4% 36/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	35.0% 36/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
Psychiatric disorders Libido	24.3% 27/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	21.4% 22/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
Psychiatric disorders Mood alteration - agitation	23.4% 26/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	18.4% 19/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
Psychiatric disorders Mood alteration - anxiety	24.3% 27/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	30.1% 31/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
Psychiatric disorders Mood alteration - depression	32.4% 36/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	27.2% 28/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
Reproductive system and breast disorders Irregular menses (change from baseline)	2.7% 3/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	11.7% 12/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
Reproductive system and breast disorders Vaginal dryness	23.4% 26/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	29.1% 30/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	27.9% 31/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	33.0% 34/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.
Vascular disorders Hot flashes/flushes	43.2% 48/111 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.	60.2% 62/103 • Up to 5 years This analysis includes all eligible patients who were evaluated for adverse events.

Additional Information

Cancer Survivorship Committee Statistician

SWOG Statistics and Data Management Center

Phone: 206-667-4623

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60