Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002762
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
1999-11-01
Brief Title:
Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER
Status:
COMPLETED
Status Verified Date:
2016-07
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 Timing of breast cancer surgery may improve effectiveness of treatment and may help patients live longer
PURPOSE Clinical trial to determine whether timing of primary surgery in relation to menstrual cycle is associated with disease-free survival 5 years after surgery in women who have stage I or stage II breast cancer
PURPOSE Clinical trial to determine whether timing of primary surgery in relation to menstrual cycle is associated with disease-free survival 5 years after surgery in women who have stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Document menstrual phase follicular vs luteal by circulating hormones and menstrual history at the time of primary surgery in premenopausal women with stage I or II breast cancer
Correlate menstrual phase at primary surgery with 5-year disease-free survival in these patients
Compare the menstrual cycle data obtained by hormone levels and study-specific menstrual cycle history with information recorded in the general written record
Compare the menstrual cycle data eg hormone levels and cycle history for these women with the data for the general population
Estimate the disease-free survival of women who undergo a 2-stage surgical procedure with cancer found at both stages when the surgery is not confined to the same menstrual cycle phase
Premenopausal women age 18 to 55 years who were interviewed for menstrual history and who were surgically treated for stages I to II breast cancer had serum drawn within 1 day of surgery for estradiol progesterone and luteinizing hormone levels Menstrual history and hormone levels were used to determine menstrual phase luteal follicular and other Disease-free survival DFS and overall survival OS rates were determined by Kaplan-Meier method and were compared by using the log-rank test and Cox proportional hazard modeling
Document menstrual phase follicular vs luteal by circulating hormones and menstrual history at the time of primary surgery in premenopausal women with stage I or II breast cancer
Correlate menstrual phase at primary surgery with 5-year disease-free survival in these patients
Compare the menstrual cycle data obtained by hormone levels and study-specific menstrual cycle history with information recorded in the general written record
Compare the menstrual cycle data eg hormone levels and cycle history for these women with the data for the general population
Estimate the disease-free survival of women who undergo a 2-stage surgical procedure with cancer found at both stages when the surgery is not confined to the same menstrual cycle phase
Premenopausal women age 18 to 55 years who were interviewed for menstrual history and who were surgically treated for stages I to II breast cancer had serum drawn within 1 day of surgery for estradiol progesterone and luteinizing hormone levels Menstrual history and hormone levels were used to determine menstrual phase luteal follicular and other Disease-free survival DFS and overall survival OS rates were determined by Kaplan-Meier method and were compared by using the log-rank test and Cox proportional hazard modeling
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 |
|---|---|---|---|
| CDR0000064717 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02243 | REGISTRY | None | None |
| NSABP-BI-65 | None | None | None |