Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427245
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2007-01-25
Brief Title:
Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I Stage II or Stage III Breast Cancer
Sponsor:
Anglo Celtic Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Ovarian Protection Trial In Premenopausal Breast Cancer Patients OPTION
Status:
COMPLETED
Status Verified Date:
2007-05
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 may help prevent early menopause in patients undergoing chemotherapy for breast cancer It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer
PURPOSE This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I stage II or stage III breast cancer
PURPOSE This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin
Secondary
Compare the quality of life of patients treated with these regimens
Compare menopausal symptoms in patients treated with these regimens
Compare bone mineral density loss in patients treated with these regimens
Compare hormone levels in patients treated with these regimens
Compare menstruation in patients treated with these regimens
Compare the incidence of pregnancy in patients treated with these regimens
OUTLINE This is a randomized open-label prospective parallel group multicenter study Patients are stratified according to age 40 years vs 40 years and participating center Patients are randomized to 1 of 2 treatment arms
Arm I chemotherapy alone Patients receive neoadjuvant or adjuvant cyclophosphamide- andor anthracycline-containing chemotherapy Treatment continues for 6-8 courses in the absence of disease progression or unacceptable toxicity
Arm II chemotherapy plus goserelin for ovarian function suppression Patients receive neoadjuvant or adjuvant chemotherapy as in arm I Patients also receive goserelin subcutaneously every 3-4 weeks beginning 1-3 weeks before the start of chemotherapy Treatment with goserelin repeats every 3-4 weeks until completion of chemotherapy
Quality of life is assessed at baseline at 3 6 12 18 and 24 months and then annually for up to 5 years
After completion of study therapy patients are followed periodically for 5 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
Primary
Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin
Secondary
Compare the quality of life of patients treated with these regimens
Compare menopausal symptoms in patients treated with these regimens
Compare bone mineral density loss in patients treated with these regimens
Compare hormone levels in patients treated with these regimens
Compare menstruation in patients treated with these regimens
Compare the incidence of pregnancy in patients treated with these regimens
OUTLINE This is a randomized open-label prospective parallel group multicenter study Patients are stratified according to age 40 years vs 40 years and participating center Patients are randomized to 1 of 2 treatment arms
Arm I chemotherapy alone Patients receive neoadjuvant or adjuvant cyclophosphamide- andor anthracycline-containing chemotherapy Treatment continues for 6-8 courses in the absence of disease progression or unacceptable toxicity
Arm II chemotherapy plus goserelin for ovarian function suppression Patients receive neoadjuvant or adjuvant chemotherapy as in arm I Patients also receive goserelin subcutaneously every 3-4 weeks beginning 1-3 weeks before the start of chemotherapy Treatment with goserelin repeats every 3-4 weeks until completion of chemotherapy
Quality of life is assessed at baseline at 3 6 12 18 and 24 months and then annually for up to 5 years
After completion of study therapy patients are followed periodically for 5 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000526368 | REGISTRY | None | None |
| EUDRACT-2004-000133-11 | None | None | None |
| CRUK-BR0402 | None | None | None |
| ISRCTN84856516 | None | None | None |
| EU-20680 | Registry Identifier | PDQ Physician Data Query | None |