NCT00005079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1999

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

May 15, 2013

Status Verified

April 1, 2003

First QC Date

April 6, 2000

Last Update Submit

May 14, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancer

Interventions

conventional surgeryPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed stage I, II, or III primary breast cancer undergoing breast surgery * Invasive disease (e.g., lobular or ductal) * No bilateral disease * No distant metastases * Premenopausal * Regular menses (no amenorrhea of more than 90 days) without hormone replacement * Documented last menstrual period * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Premenopausal Sex: * Female Menopausal status: * See Disease Characteristics Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other prior malignancies * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No preoperative chemotherapy Endocrine therapy: * No concurrent hormonal replacement therapy * No concurrent interruptive oral contraceptive use of less than 3 months Radiotherapy: * Not specified Surgery: * See Disease Characteristics * No prior hysterectomy and/or bilateral oophorectomy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Helena R. Chang, MD, PhD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2000

First Posted

January 27, 2003

Study Start

January 1, 1999

Study Completion

October 1, 2004

Last Updated

May 15, 2013

Record last verified: 2003-04

Locations

US(2)