The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
NCT ID: NCT04129216
Last Updated: 2024-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2019-02-20
2022-11-10
Brief Summary
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Detailed Description
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The hypothesis of this study is that short-term, preoperative hormonal treatment will induce genetic changes associated with reduced proliferation, including lower Ki67 expression, and changes in Estrogen Receptor (ER) and Progesterone Receptor (PR) expression. The data from such investigation will be very helpful in advancing the individualized care to women with breast cancer.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Tamoxifen arm
for premenopausal patients
Tamoxifen Citrate
10mg administered daily. Patients take this drug for 2-6 weeks
Blueprint
studies the genomics of the tumor and tumor behavior
Mammaprint
studies the genomics of the tumor
Letrozole arm
for postmenopausal patients
Letrozole
2.5mg is administered daily. Patients take this drug for 2-6 weeks
Blueprint
studies the genomics of the tumor and tumor behavior
Mammaprint
studies the genomics of the tumor
Exemestane arm
for postmenopausal patients
Exemestane
25mg is administered daily. Patients take this drug for 2-6 weeks.
Blueprint
studies the genomics of the tumor and tumor behavior
Mammaprint
studies the genomics of the tumor
Interventions
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Tamoxifen Citrate
10mg administered daily. Patients take this drug for 2-6 weeks
Letrozole
2.5mg is administered daily. Patients take this drug for 2-6 weeks
Exemestane
25mg is administered daily. Patients take this drug for 2-6 weeks.
Blueprint
studies the genomics of the tumor and tumor behavior
Mammaprint
studies the genomics of the tumor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Co-enrollment in the FLEX Registry
* Estrogen Receptor Positive (ER+) Progesterone Receptor Positive (PR+) confirmed hormone receptor status measured by immunohistochemistry (IHC)
* Patients should understand patients' condition and be able to give informed consent to participate
Exclusion Criteria
* Allergic reactions/hypersensitivity to tamoxifen, letrozole, or exemestane or any of the ingredients of these drugs.
* Any contraindication to hormonal therapy, such as history of thromboembolic disease or uterine cancer.
* Patients without invasive disease (stage 0)
* Patients with metastatic breast cancer(stageIV)
* Patients that are Human Epidermal Growth Factor 2+(HER2+) by IHC/Fluorescence in situ hybridization (FISH).
18 Years
90 Years
ALL
No
Sponsors
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Agendia
INDUSTRY
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Mehran Habibi, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bayview
Locations
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Johns Hopkins Bayview Hospital
Baltimore, Maryland, United States
Countries
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References
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Suman VJ, Ellis MJ, Ma CX. The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer. Chin Clin Oncol. 2015 Sep;4(3):34. doi: 10.3978/j.issn.2304-3865.2015.09.01.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00130428
Identifier Type: -
Identifier Source: org_study_id
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