Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
NCT ID: NCT05150652
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
8 participants
INTERVENTIONAL
2022-02-18
2026-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Neoadjuvant Endocrine Therapy
Participants will begin treatment with Anastrozole. If not tolerated well, participants will discontinue and begin treatment using Letrozole. If not tolerated well, participants will discontinue and begin treatment using Exemestane. If not tolerated well, participants will discontinue and begin treatment on Tamoxifen.
Anastrozole 1mg
Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.
Letrozole 2.5mg
Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.
Exemestane 25 mg
Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.
Tamoxifen
Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.
Interventions
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Anastrozole 1mg
Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.
Letrozole 2.5mg
Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.
Exemestane 25 mg
Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.
Tamoxifen
Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically lymph node negative
* Eligible for anti-endocrine treatment (per medical oncologist)
* Postmenopausal women
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* High grade tumor
* Synchronous non-breast malignancy
* Receiving any other investigational agents that could impact the efficacy of this trial regimen
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or other agents used in study
* Uncontrolled intercurrent illness
* Medical, psychiatric or other condition and/or social situations that would limit compliance with study requirements
18 Years
99 Years
FEMALE
No
Sponsors
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Irada Ibrahim-zada
OTHER
Responsible Party
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Irada Ibrahim-zada
Assistant Professor
Principal Investigators
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Irada Ibrahim-zada, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Countries
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References
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McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.
Other Identifiers
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MCC-21-BRE-54
Identifier Type: -
Identifier Source: org_study_id
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