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Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer

NCT01293032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-07-12

Study results available
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Summary

This randomized pilot clinical trial studied whether the Oncotype DX gene expression "Recurrence Score" (RS) would be useful for helping make a decision about which type of pre-operative treatment, hormone therapy or chemotherapy would be a better for patients with hormone responsive cancers that were not suitable for breast conserving surgery. The RS is currently used to predict the risk of distant recurrence and the benefit of the addition of chemotherapy to hormonal therapy in the adjuvant setting.

Conditions

  • Ductal Breast Carcinoma in Situ
  • Lobular Breast Carcinoma in Situ
  • Stage II Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIB Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer

Interventions

PROCEDURE

Neoadjuvant Therapy

Undergo neoadjuvant therapy

PROCEDURE

Therapeutic Conventional Surgery

Undergo therapeutic conventional surgery

OTHER

Laboratory Biomarker Analysis

Correlative studies

GENETIC

Gene Expression Analysis

Undergo Oncotype Dx gene expression profiling. The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).

DRUG

Systemic Chemotherapy

Undergo chemotherapy

DRUG

Tamoxifen Citrate

Undergo hormonal therapy

DRUG

Aromatase Inhibition Therapy

Undergo hormonal therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Harry D. Bear, MD, PhD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-05-31
Completion
2016-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01293032 on ClinicalTrials.gov