Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090844
Status:
TERMINATED
Last Update Posted:
2021-01-28
First Post:
2004-09-07
Brief Title:
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
Preservation of Ovarian Function in Young Women Treated With Neo Adjuvant Chemotherapy for Breast Cancer A Randomized Trial Using the Gonadotropin-releasing Hormone GnRH Agonist Triptorelin During Chemotherapy
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early closure due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Chemoprotective drugs such as triptorelin may protect normal ovarian cells from the side effects of chemotherapy
PURPOSE This randomized phase II trial is studying how well triptorelin works in preserving ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast cancer
PURPOSE This randomized phase II trial is studying how well triptorelin works in preserving ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy
Secondary
Determine the rate of chemotherapy-related amenorrhea in patients treated with this drug
Determine the value of inhibin A and B as alternative markers of premature ovarian failure in patients treated with this drug
Determine quality of life of patients treated with this drug
Determine disease-free and overall survival of patients treated with this drug
OUTLINE This is a randomized multicenter study Patients are stratified according to age 35 years vs 35 to 39 years vs 39 years concurrent neoadjuvant or adjuvant systemic chemotherapy fluorouracil epirubicin and cyclophosphamide 6 courses OR fluorouracil doxorubicin and cyclophosphamide 6 courses vs doxorubicin and cyclophosphamide AC 4 courses vs doxorubicin and cyclophosphamide AC 4 courses followed by a taxane 4 courses and hormone receptor status estrogen receptor ER- AND progesterone receptor PR-negative vs ER- OR PR-positive
Arm I Beginning within 1-4 weeks before the start of chemotherapy patients receive triptorelin intramuscularly once monthly for 4-6 months during neoadjuvant or adjuvant systemic chemotherapy
Arm II Patients receive neoadjuvant or adjuvant systemic chemotherapy only Quality of life is assessed at baseline monthly during treatment every 6 months for 2 years and then annually for 3 years
Patients are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 138 patients 69 per treatment arm will be accrued for this study within 35 months
Primary
Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy
Secondary
Determine the rate of chemotherapy-related amenorrhea in patients treated with this drug
Determine the value of inhibin A and B as alternative markers of premature ovarian failure in patients treated with this drug
Determine quality of life of patients treated with this drug
Determine disease-free and overall survival of patients treated with this drug
OUTLINE This is a randomized multicenter study Patients are stratified according to age 35 years vs 35 to 39 years vs 39 years concurrent neoadjuvant or adjuvant systemic chemotherapy fluorouracil epirubicin and cyclophosphamide 6 courses OR fluorouracil doxorubicin and cyclophosphamide 6 courses vs doxorubicin and cyclophosphamide AC 4 courses vs doxorubicin and cyclophosphamide AC 4 courses followed by a taxane 4 courses and hormone receptor status estrogen receptor ER- AND progesterone receptor PR-negative vs ER- OR PR-positive
Arm I Beginning within 1-4 weeks before the start of chemotherapy patients receive triptorelin intramuscularly once monthly for 4-6 months during neoadjuvant or adjuvant systemic chemotherapy
Arm II Patients receive neoadjuvant or adjuvant systemic chemotherapy only Quality of life is assessed at baseline monthly during treatment every 6 months for 2 years and then annually for 3 years
Patients are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 138 patients 69 per treatment arm will be accrued for this study within 35 months
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 |
|---|---|---|---|
| NCI-7031 | OTHER | National Cancer Institute Division of Cancer Prevention | httpsreporternihgovquickSearchP30CA076292 |
| P30CA076292 | NIH | None | None |
| MCC-0203 | OTHER | None | None |