NCT00540852

Brief Summary

Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2002

Longer than P75 for not_applicable breast-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

8.6 years

First QC Date

October 4, 2007

Last Update Submit

October 28, 2022

Conditions

Breast Cancer

Keywords

Breast cancer receiving chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic tool

    Diffuse Optical Spectroscopy Imaging Breast Cancer Tumor in the response of Chemotherapy

    12 weeks

Study Arms (1)

Diagnostic Tool

OTHER

Diffuse Optical Spectroscopy Imaging

Device: Diffuse Optical Spectroscopy Imaging

Interventions

Diffuse Optical Spectroscopy ImagingDEVICE

Diffuse Optical Spectroscopy Imaging

Diagnostic Tool

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
  • Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy

You may not qualify if:

  • Female pregnant and age less than 21 years old and have no diagnosis of breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beckman Laser Institute University Of California Irvine

Irvine, California, 92612, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David Hsiang, M.D

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David Hsiang, M.D., Division of Surgical Oncology

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 8, 2007

Study Start

June 1, 2002

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(2)