- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H2W 1T8
- Centre Hospitalier de l'Université de Montréal , Hôtel-Dieu Hospital
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-
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Cancer Institute
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center
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Charlotte, North Carolina, United States, 28204
- Forsyth Regional Cancer Center
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Greensboro, North Carolina, United States, 27403
- Cone Health Cancer Center
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Texas
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Houston, Texas, United States, 77030
- Methodist Cancer Center
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Virginia
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Lynchburg, Virginia, United States, 24501
- Lynchburg Hematology Oncology Clinic, Inc
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The treating surgeon must determine that breast conservation therapy (BCT) would be made more feasible by reducing tumor size using neoadjuvant systemic therapy
- 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:
- FNA alone to diagnose the primary tumor
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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:
|
Correlative studies
Other Names:
Undergo neoadjuvant therapy
Other Names:
Undergo therapeutic conventional surgery
Undergo Oncotype Dx gene expression profiling.
The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).
Undergo hormonal therapy
Other Names:
Undergo hormonal therapy
Other Names:
|
EXPERIMENTAL: 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:
|
Correlative studies
Other Names:
Undergo neoadjuvant therapy
Other Names:
Undergo therapeutic conventional surgery
Undergo Oncotype Dx gene expression profiling.
The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).
Undergo hormonal therapy
Other Names:
Undergo hormonal therapy
Other Names:
|
EXPERIMENTAL: 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:
|
Correlative studies
Other Names:
Undergo neoadjuvant therapy
Other Names:
Undergo therapeutic conventional surgery
Undergo Oncotype Dx gene expression profiling.
The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).
Undergo chemotherapy
|
EXPERIMENTAL: Group 3 (RS > 25)
Patients with a high RS (> 25) assigned to Group 3, neoadjuvant chemotherapy as in Group 2 Arm 2. Treatment:
|
Correlative studies
Other Names:
Undergo neoadjuvant therapy
Other Names:
Undergo therapeutic conventional surgery
Undergo Oncotype Dx gene expression profiling.
The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).
Undergo chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment
Time Frame: Up to 2 years
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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.
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Up to 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Neoplasms, Ductal, Lobular, and Medullary
- Carcinoma, Ductal
- Carcinoma in Situ
- Breast Neoplasms
- Carcinoma
- Breast Carcinoma In Situ
- Carcinoma, Intraductal, Noninfiltrating
- Carcinoma, Lobular
- Carcinoma, Ductal, Breast
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
- Aromatase Inhibitors
Other Study ID Numbers
- MCC-13311
- P30CA016059 (U.S. NIH Grant/Contract)
- NCI-2010-02342 (REGISTRY: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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