Completed

MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Behavioral Data

+ procedure Data

Collected from today forward - Prospective
BehavioralProcedure
Who is being recruted

Breast Diseases+6

+ Neoplasms

+ Neoplasms by Site

From 18 to 55 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: June 1996
See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 12, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00002762
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 12, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1118 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SitePathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesBreast NeoplasmsPostoperative Complications

Criteria

4 inclusion criteria required to participate
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

Regular menstrual cycles of 21- to 35-days duration

Women age 18 to 55 years

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

4 exclusion criteria prevent from participating
Lactation within the past 3 months

galactorrhea

neoadjuvant therapy

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 54 locations

MBCCOP - Gulf Coast

Mobile, United StatesOpen MBCCOP - Gulf Coast in Google Maps

CCOP - Western Regional, Arizona

Phoenix, United States

University of Arkansas for Medical Sciences

Little Rock, United States

Scripps Cancer Center at Scripps Clinic

La Jolla, United States
Completed54 Study Centers