NCT01293032

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

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

Type	Name	Description
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

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-05-01
• Completion: 2016-03-01
• First posted: 2011-02-10
• Last updated: 2016-07-12
• Results posted: 2016-07-12

Locations

8 sites across 2 countries: United States, Canada