Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005079
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2000-04-06
Brief Title:
Timing of Menstrual Cycle and Surgery in Treating Premenopausal Women With Stage I Stage II or Stage III Breast Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Timing of Breast Cancer Surgery Menstrual Cycle and Prognosis
Status:
COMPLETED
Status Verified Date:
2003-04
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 The timing of breast cancer surgery within the menstrual cycle may affect outcome It is not yet known if treatment is more effective during the initial or final phase of the menstrual cycle
PURPOSE Phase III trial to determine the effect of menstrual cycle phase at surgery in treating premenopausal women who have stage I stage II or stage III breast cancer
PURPOSE Phase III trial to determine the effect of menstrual cycle phase at surgery in treating premenopausal women who have stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Determine if the timing of breast surgery during the menstrual cycle impacts disease recurrence progression or death among different racial groups in premenopausal women with stage I II or III breast cancer
Determine if definitive breast cancer surgeries eg lumpectomy or mastectomy performed during the follicular phase result in poorer prognosis recurrence disease progression or death compared with surgeries performed during the midcycle or luteal phases in this patient population
OUTLINE This is a multicenter study
Patients undergo either fine needle aspiration concurrently with definitive breast surgery mastectomy or lumpectomy or needle-directed excisional biopsy followed by definitive breast surgery
Patients undergo serum collection for hormonal analysis preoperatively 24 hours post operatively at days 7 and 14 and at 3 months and urine collection for hormonal analysis beginning 24 hours prior to surgery and continuing daily until the onset of the next menses
Patients complete a 30-minute telephone interview regarding medical family occupational and reproductive history and lifestyle habits eg diet exercise or environmental exposures Beginning 24 hours prior to surgery and continuing until the onset of the next menses patients complete a menstrual cycle journal indicating the start and length of menses
Patients undergoing mastectomy are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter Patients undergoing adjuvant therapy are followed every 3 months for 3 years and then every 6 months thereafter or every 4 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 400 patients will be accrued for this study within 25 years
Determine if the timing of breast surgery during the menstrual cycle impacts disease recurrence progression or death among different racial groups in premenopausal women with stage I II or III breast cancer
Determine if definitive breast cancer surgeries eg lumpectomy or mastectomy performed during the follicular phase result in poorer prognosis recurrence disease progression or death compared with surgeries performed during the midcycle or luteal phases in this patient population
OUTLINE This is a multicenter study
Patients undergo either fine needle aspiration concurrently with definitive breast surgery mastectomy or lumpectomy or needle-directed excisional biopsy followed by definitive breast surgery
Patients undergo serum collection for hormonal analysis preoperatively 24 hours post operatively at days 7 and 14 and at 3 months and urine collection for hormonal analysis beginning 24 hours prior to surgery and continuing daily until the onset of the next menses
Patients complete a 30-minute telephone interview regarding medical family occupational and reproductive history and lifestyle habits eg diet exercise or environmental exposures Beginning 24 hours prior to surgery and continuing until the onset of the next menses patients complete a menstrual cycle journal indicating the start and length of menses
Patients undergoing mastectomy are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter Patients undergoing adjuvant therapy are followed every 3 months for 3 years and then every 6 months thereafter or every 4 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 400 patients will be accrued for this study within 25 years
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 |
|---|---|---|---|
| CDR0000067686 | REGISTRY | None | None |
| NCI-G00-1724 | Registry Identifier | PDQ Physician Data Query | None |
| UCSD-985772 | None | None | None |