CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 59 enrolled
Drug / intervention
Gene Expression Analysis +6 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01293032
NCT01293032N/ACompleted
CompareCT.gov

Choosing Neoadjuvant Chemotherapy Versus Hormonal Therapy for Breast Cancer Based on Gene Expression Profile

Virginia Commonwealth University·interventional·Posted Feb 10, 2011·Updated Jul 12, 2016

In Brief

A clinical study evaluating Neoadjuvant Therapy, Therapeutic Conventional Surgery, and 5 other interventions for Ductal Breast Carcinoma in Situ and 6 related conditions. Completed, enrolled 59 participants across 8 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuctal 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
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2011
Enrollment StartApr 1, 2011
Primary CompletionMay 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.4 years ago

Interventions

Neoadjuvant Therapyprocedure

Undergo neoadjuvant therapy

Therapeutic Conventional Surgeryprocedure

Undergo therapeutic conventional surgery

Laboratory Biomarker Analysisother

Correlative studies

Gene Expression Analysisgenetic

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

Systemic Chemotherapydrug

Undergo chemotherapy

Tamoxifen Citratedrug

Undergo hormonal therapy

Aromatase Inhibition Therapydrug

Undergo hormonal therapy