None listed
Conditions
Brief summary
The purpose of this study is to evaluate whether the timing of breast cancer surgery during a woman’s menstrual cycle affects her ultimate outcome- the likelihood of recurrence of breast cancer or death from breast cancer. This study involves taking a small sample of blood from the woman close to her surgery to evaluate her menstrual phase on the basis of hormones in her blood. The woman will then go on to have whichever treatments for her breast cancer that she decides with her doctor. The woman will be observed for at least 5 years and information regarding her treatment and disease progression will be submitted.
Interventions
Patients will undergo either a one-stage surgical procedure (open biopsy followed by mastectomy or breastconserving
approach) or two-stage surgical procedure (open biopsy followed later by mastectomy or breast-conserving approach) and will be followed every year for 10 years.
Sponsors
North Central Cancer Treatment Group
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
One-stage surgical procedure (open biopsy followed by mastectomy or breast conserving approach):Required characteristics• Premenopausal women with regular menstrual periods (21–35 days) and pathologic stage I–II breast cancer.• One-stage surgical procedure plus serum drawn within one calendar day of procedure.• FNA, core needle, or stereotactic biopsy is allowed at any time prior to the one-stage procedure. Sentinel node dissection/axillary node dissection is also acceptable.• The use of chemotherapy and/or radiation therapy is allowable according to the usual internationally accepted criteria.• All gross disease removed including DCIS.• Contraindications• Pregnant women.• Previous breast cancer.• Any previous cancer.
Exclusion criteria
Exceptions: 1) >10 years disease free or 2) squamous or basal cell skin carcinoma.• Neoadjuvant treatment.• Galactorrhea.• Lactating within the past 3 months.• Oral contraceptive use within the last 3 months.• Stage III or IV disease.Two-stage surgical procedure (open biopsy followed later by mastectomy or breast-conserving approach):Required characteristics:• Pathologic stage I-II breast cancer.• Premenopausal women with regular menstrual periods (21–35 days).• Undergoing a two-stage surgical procedure.• Serum drawn within one calendar day of open biopsy.
Outcome results
None listed