Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
NCT ID: NCT01293032
Last Updated: 2016-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2011-04-30
2016-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 (RS < 11)
Patients with a Recurrence Score (RS) less than 11 (RS \<11) are assigned to Group 1, neoadjuvant hormonal therapy either tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.
Treatment:
* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
* Hormonal therapy:
* Tamoxifen Citrate (pre-menopausal women) OR
* Aromatase Inhibition Therapy (post-menopausal women)
Neoadjuvant Therapy
Undergo neoadjuvant therapy
Therapeutic Conventional Surgery
Undergo therapeutic conventional surgery
Laboratory Biomarker Analysis
Correlative studies
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).
Tamoxifen Citrate
Undergo hormonal therapy
Aromatase Inhibition Therapy
Undergo hormonal therapy
Group 2 Arm 1 (RS 11-25)
Patients with an intermediate RS (11-25) assigned to Group 2. Randomized to Arm 1, neoadjuvant hormonal therapy as in Group 1.
Treatment:
* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
* Hormonal therapy:
* Tamoxifen Citrate (pre-menopausal women) OR
* Aromatase Inhibition Therapy (post-menopausal women)
Neoadjuvant Therapy
Undergo neoadjuvant therapy
Therapeutic Conventional Surgery
Undergo therapeutic conventional surgery
Laboratory Biomarker Analysis
Correlative studies
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).
Tamoxifen Citrate
Undergo hormonal therapy
Aromatase Inhibition Therapy
Undergo hormonal therapy
Group 2 Arm 2 (RS 11-25)
Patients with an intermediate RS(11-25) assigned to Group 2. Randomized to Arm 2, neoadjuvant chemotherapy 6-8 courses of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.
Treatment:
* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
* Systemic chemotherapy
Neoadjuvant Therapy
Undergo neoadjuvant therapy
Therapeutic Conventional Surgery
Undergo therapeutic conventional surgery
Laboratory Biomarker Analysis
Correlative studies
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).
Systemic Chemotherapy
Undergo chemotherapy
Group 3 (RS > 25)
Patients with a high RS (\> 25) assigned to Group 3, neoadjuvant chemotherapy as in Group 2 Arm 2.
Treatment:
* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
* Systemic chemotherapy
Neoadjuvant Therapy
Undergo neoadjuvant therapy
Therapeutic Conventional Surgery
Undergo therapeutic conventional surgery
Laboratory Biomarker Analysis
Correlative studies
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).
Systemic Chemotherapy
Undergo chemotherapy
Interventions
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Neoadjuvant Therapy
Undergo neoadjuvant therapy
Therapeutic Conventional Surgery
Undergo therapeutic conventional surgery
Laboratory Biomarker Analysis
Correlative studies
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).
Systemic Chemotherapy
Undergo chemotherapy
Tamoxifen Citrate
Undergo hormonal therapy
Aromatase Inhibition Therapy
Undergo hormonal therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient must have signed and dated an institutional review board (IRB) approved consent form that conforms to federal and institutional guidelines
* The patient must be female
* The patient must be greater than or equal to 18 years old
* The patient must have an Eastern Cooperative Oncology Group Score (ECOG) performance status of 0 or 1
* The diagnosis of invasive carcinoma of the breast must have been made by core needle biopsy
* The primary breast tumor must be \>= 2 cm by physical exam or imaging
* Ipsilateral axillary lymph nodes must be evaluated by imaging (MRI or ultrasound) within 6 weeks prior to randomization; If indicated for abnormal lymph nodes, fine needle aspirate (FNA) or core biopsy must be performed.
* The tumor must have been determined to be HER2-negative as follows:
* Fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to Chromosome 17 centromere (CEP17) must be \< 2.2) or, if a ratio was not performed, the HER2 gene copy number must be \< 4 per nucleus; or
* Chromogenic in situ hybridization (CISH) is performed, the result must indicate a HER2 gene copy number of \< 6 per nucleus; or
* Immunohistochemistry (IHC) 0-1+; or
* IHC 2+ and FISH-negative or CISH-negative
* The tumor must have been determined to be ER+ and/or progesterone positive (PgR+) defined as \> 10% tumor staining by immunohistochemistry
* The patient must have been evaluated by a treating physician, reviewed and discussed by the multi-disciplinary breast team, and considered to be a candidate for chemotherapy
Exclusion Criteria
* Excisional biopsy or lumpectomy performed prior to randomization
* Surgical axillary staging procedure or sentinel node (SN) biopsy performed prior to registration
* Tumors clinically staged as including inflammatory breast cancer
* Ipsilateral cN2b or cN3 disease (patients with cN1 or cN2a disease are eligible)
* Definitive clinical or radiologic evidence of metastatic disease (Note: chest imaging \[mandatory for all patients\] and other imaging \[if required\] must have been performed within 6 weeks prior to randomization)
* Synchronous or metachronous contralateral invasive breast cancer; (patients with synchronous and/or metachronous contralateral ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are eligible)
* HER2 test result of IHC 3+, regardless of FISH results, if performed
* Any history of ipsilateral invasive breast cancer or ipsilateral DCIS if treated with radiation therapy (RT); (patients with synchronous or metachronous ipsilateral LCIS are eligible)
* History of non-breast malignancies, except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin, within 5 years prior to randomization
* Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to registration
* Cardiac disease (history of and/or active disease) that would preclude the use of chemotherapy
* Pregnancy or lactation at the time of randomization; (Note: pregnancy testing must be performed within 2 weeks prior to randomization for women of childbearing potential)
* Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
* Use of any investigational product within 30 days prior to registration
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Harry D. Bear, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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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
Countries
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Related Links
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VCU Massey Cancer Center
Other Identifiers
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NCI-2010-02342
Identifier Type: REGISTRY
Identifier Source: secondary_id
MCC-13311
Identifier Type: -
Identifier Source: org_study_id
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