NCT00088829

Brief Summary

RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment. PURPOSE: This clinical trial is studying how well genetic testing works in predicting response to paclitaxel in women who have unresected breast cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2001

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

July 11, 2018

Completed
Last Updated

July 11, 2018

Status Verified

May 1, 2018

Enrollment Period

11.7 years

First QC Date

August 4, 2004

Results QC Date

May 2, 2018

Last Update Submit

June 15, 2018

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerstage IA breast cancerstage IB breast cancerHER2-negative breast cancerHER2-positive breast cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Response

    Due to the early termination of the study, this data for this outcome was not collected.

    3 months

Study Arms (1)

Paclitaxel

EXPERIMENTAL

Paclitaxel given before surgery

Drug: paclitaxelGenetic: microarray analysisProcedure: biopsyProcedure: neoadjuvant therapy

Interventions

PaclitaxelDRUG

subjects will receive paclitaxel neoadjuvantly

Paclitaxel
microarray analysisGENETIC

subjects will have a biopsy to collect tissue for gene microarray analysis

Paclitaxel
biopsyPROCEDURE

All subjects will have a biopsy to collect tissue

Paclitaxel
neoadjuvant therapyPROCEDURE

paclitaxel is given neoadjuvantly

Paclitaxel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed infiltrating carcinoma of the breast
  • Unresected disease
  • High-risk (\> 50% risk of relapse) disease, including any of the following high-risk markers:
  • Estrogen receptor- and progesterone receptor- negative
  • Palpable axillary lymph nodes
  • Grade 3 histology
  • S phase fraction \> 10%
  • Ki67 \> 30%
  • Disease that warrants combination therapy with doxorubicin, cyclophosphamide, and paclitaxel
  • HER2/neu negative or positive
  • Hormone receptor status:
  • Not specified
  • Menopausal status
  • Known
  • Performance status
  • +5 more criteria

You may not qualify if:

  • uncontrolled congestive heart failure
  • myocardial infarction within the past 6 months
  • unstable angina
  • uncontrolled hypertension
  • pregnant or nursing
  • serious bacterial, viral, or fungal infection requiring ongoing treatment
  • severe peripheral neuropathy
  • poor psychiatric risk
  • history of any other known serious co-morbid medical or psychiatric condition
  • prior cytotoxic therapy for breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PaclitaxelMicroarray AnalysisBiopsyNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesMicrochip Analytical ProceduresInvestigative TechniquesCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeCombined Modality TherapyTherapeutics

Results Point of Contact

Title
Claudine Isaacs, MD
Organization
Georgetown University Medical Center
isaacsc@georgetown.edu
202-444-3677

Study Officials

  • Minetta C. Liu, MD

    Lombardi Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

April 1, 2001

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 11, 2018

Results First Posted

July 11, 2018

Record last verified: 2018-05

Locations

US(1)