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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Breast Cancer; Perioperative/Postoperative Complications

Treatments: Behavioral: patient interviewing to obtain menstrual history; Procedure: blood sampling

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT00002762

NCCTG-N9431

NCI-2012-02243 (Registry Identifier)

NSABP-BI-65

CDR0000064717 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 (e.g., 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.

Enrollment: 1,118 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women age 18 to 55 years
2. Regular menstrual cycles of 21- to 35-days duration
3. Pathologic stages I to II breast cancer, in whom all gross disease-including ductal carcinoma in situ-was surgically removed either in a one-stage or two-stage procedure.
4. required serum be drawn within 1 calendar day of the lumpectomy/mastectomy for women who underwent a one-stage procedure and within 1 calendar day of each stage for women who underwent a two-stage procedure.

Exclusion criteria

1. Lactation within the past 3 months
2. galactorrhea
3. neoadjuvant therapy
4. previous breast cancer, and history of any cancer (except squamous or basal cell skin carcinoma) in which the patient was not disease-free for at least 10 years

Trial design

1,118 participants in 1 patient group

Patient interviewing + blood sampling

Description:

Patients were interviewed at the time of the primary cancer surgery to determine the menstrual history. Blood sampling occurred within 1 day of surgery, and serum samples were shipped frozen to a central laboratory (Mayo Medical Laboratory, Rochester, MN) for E2, Pg, and LH determinations. Serum hormone levels, menstrual cycle length, and day of last menses were used to determine the menstrual phase at which surgery occurred. Patients were observed every 6 months for the first year postregistration and annually for the next 2 to 10 years postregistration for adjuvant therapy information, disease recurrence, and death.

Treatment:

Behavioral: patient interviewing to obtain menstrual history

Procedure: blood sampling