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.
Assessed the feasibility of carrying out a large-scale multi-center trial in which recurrence score (RS) was used to select treatment type in the neoadjuvant setting. Whether patients with intermediate RS were willing to be randomized between hormonal and chemotherapy. The treatment received was not experimental and considered standard treatment for the type of cancer the participants had. What was experimental included the way in which they were assigned to a type of treatment. The design of this study was used to help determine if RS can be used to predict which type of treatment women with breast cancer are most likely to benefit from. OUTLINE: Patients are assigned to 1 of 3 groups based on RS following Oncotype Dx gene expression profiling. * GROUP 1 (RS \< 11): Patients receive neoadjuvant hormonal therapy comprising tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity. * GROUP 2 (RS 11-25): Patients are randomized to 1 of 2 treatment arms: * ARM 1: Patients receive neoadjuvant hormonal therapy as in group I. * ARM 2: Patients receive 6-8 courses of neoadjuvant chemotherapy comprising an anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity. * GROUP 3 (RS \> 25): Patients receive neoadjuvant chemotherapy as in group 2 arm 2. All patients undergo surgery and receive hormonal therapy for at least 5 years. After completion of study treatment, patients are followed up periodically.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Undergo neoadjuvant therapy
Undergo therapeutic conventional surgery
Correlative studies
Undergo Oncotype Dx gene expression profiling. The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).
Undergo chemotherapy
Undergo hormonal therapy
Undergo hormonal therapy
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Forsyth Regional Cancer Center
Charlotte, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Methodist Cancer Center
Houston, Texas, United States
Lynchburg Hematology Oncology Clinic, Inc
Lynchburg, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Centre Hospitalier de l'Université de Montréal , Hôtel-Dieu Hospital
Montreal, Quebec, Canada
The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment
The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.
Time frame: Up to 2 years
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