ACTIVE_NOT_RECRUITING

Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

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Conditions

Breast CancerHER2-negative Breast CancerNode-negative Breast CancerBreast CarcinomaNeoadjuvant endocrine therapyEarly stage

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.

Official Title

Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Quick Facts

Study Start:2022-02-18
Study Completion:2026-06-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05150652

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically confirmed invasive breast cancer, clinically stage I-II.
  2. * Clinically lymph node negative
  3. * Eligible for anti-endocrine treatment (per medical oncologist)
  4. * Postmenopausal women
  5. * Ability to understand and the willingness to sign a written informed consent document
  1. * Progesterone receptor negativity
  2. * High grade tumor
  3. * Synchronous non-breast malignancy
  4. * Receiving any other investigational agents that could impact the efficacy of this trial regimen
  5. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or other agents used in study
  6. * Uncontrolled intercurrent illness
  7. * Medical, psychiatric or other condition and/or social situations that would limit compliance with study requirements

Contacts and Locations

Principal Investigator

Irada Ibrahim-zada, MD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: Irada Ibrahim-zada

  • Irada Ibrahim-zada, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-18
Study Completion Date2026-06-09

Study Record Updates

Study Start Date2022-02-18
Study Completion Date2026-06-09

Terms related to this study

Keywords Provided by Researchers

  • Neoadjuvant endocrine therapy
  • Early stage

Additional Relevant MeSH Terms

  • Breast Cancer
  • HER2-negative Breast Cancer
  • Node-negative Breast Cancer
  • Breast Carcinoma