S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
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ClinicalTrials.gov Identifier: NCT00068601 |
Recruitment Status :
Completed
First Posted : September 11, 2003
Results First Posted : April 4, 2017
Last Update Posted : December 30, 2019
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care |
Conditions |
Breast Cancer Infertility Menopausal Symptoms |
Interventions |
Drug: cyclophosphamide Drug: goserelin acetate |
Enrollment | 257 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Standard Chemotherapy | Chemotherapy Plus Goserelin |
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Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen |
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 |
Period Title: Overall Study | ||
Started | 131 | 126 |
Completed | 69 | 66 |
Not Completed | 62 | 60 |
Reason Not Completed | ||
Ineligible | 11 | 13 |
Not evaluable: withdrew consent | 5 | 4 |
Not evaluable: hysterectomy/oophorectomy | 2 | 4 |
Death | 11 | 3 |
Lost to Follow-up | 3 | 2 |
Missing primary outcome data | 30 | 34 |
Arm/Group Title | Arm 1 | Arm 2 | Total | |
---|---|---|---|---|
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Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen |
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 of all reporting groups | |
Overall Number of Baseline Participants | 113 | 105 | 218 | |
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Patients who are both eligible and evaluable
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 113 participants | 105 participants | 218 participants | |
38.7
(25.1 to 49.9)
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37.6
(26.1 to 48.6)
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37.7
(25.1 to 49.9)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 113 participants | 105 participants | 218 participants | |
Female |
113 100.0%
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105 100.0%
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218 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Name/Title: | Cancer Survivorship Committee Statistician |
Organization: | SWOG Statistics and Data Management Center |
Phone: | 206-667-4623 |
Responsible Party: | Southwest Oncology Group |
ClinicalTrials.gov Identifier: | NCT00068601 |
Obsolete Identifiers: | NCT00696267 |
Other Study ID Numbers: |
CDR0000327758 S0230 ( Other Identifier: SWOG ) CALGB-40401 ( Other Identifier: CALGB ) IBCSG-34-05 ( Other Identifier: IBCSG ) U10CA037429 ( U.S. NIH Grant/Contract ) |
First Submitted: | September 10, 2003 |
First Posted: | September 11, 2003 |
Results First Submitted: | December 16, 2016 |
Results First Posted: | April 4, 2017 |
Last Update Posted: | December 30, 2019 |