Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068601
Status:
COMPLETED
Last Update Posted:
2019-12-30
First Post:
2003-09-10
Brief Title:
S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage Hormone-Receptor Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Goserelin blocks hormone production in the ovaries It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure early menopause in women receiving chemotherapy for breast cancer
PURPOSE This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I stage II or stage IIIA breast cancer
PURPOSE This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy with vs without goserelin
Secondary
Compare the rate of ovarian dysfunction in patients treated with these regimens
Compare ovarian reserve in patients treated with these regimens
Describe the pregnancy rates in patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to age under 40 vs 40 to 49 and planned chemotherapy regimen 3- to 4-monthcourse anthracycline-based vs 6- to 8-monthcourse anthracycline-based vs 3- to 4-monthcourse non-anthracycline-based vs 6- to 8-monthcourse non-anthracycline-based Patients are randomized to 1 of 2 treatment arms
Arm 1 Patients receive cyclophosphamide-containing chemotherapy alone Patients are followed at 1 2 and 5 years
Arm 2 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
PROJECTED ACCRUAL A total of 416 patients 208 per treatment arm will be accrued for this study within 3 years
Primary
Compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy with vs without goserelin
Secondary
Compare the rate of ovarian dysfunction in patients treated with these regimens
Compare ovarian reserve in patients treated with these regimens
Describe the pregnancy rates in patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to age under 40 vs 40 to 49 and planned chemotherapy regimen 3- to 4-monthcourse anthracycline-based vs 6- to 8-monthcourse anthracycline-based vs 3- to 4-monthcourse non-anthracycline-based vs 6- to 8-monthcourse non-anthracycline-based Patients are randomized to 1 of 2 treatment arms
Arm 1 Patients receive cyclophosphamide-containing chemotherapy alone Patients are followed at 1 2 and 5 years
Arm 2 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
PROJECTED ACCRUAL A total of 416 patients 208 per treatment arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA037429 | NIH | IBCSG | httpsreporternihgovquickSearchU10CA037429 |
| S0230 | OTHER | None | None |
| CALGB-40401 | OTHER | None | None |
| IBCSG-34-05 | OTHER | None | None |