RECRUITING

Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

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

Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.

Official Title

Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

Quick Facts

Study Start:2017-01-17
Study Completion:2031-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02476786

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:70 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0.
  2. * Disease must be ER+ and HER2-.
  3. * Ki67 score/proliferative index ≤ 30% or low to intermediate mitotic index
  4. * Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.
  5. * 70 years of age or older.
  6. * ECOG performance status ≤ 3
  7. * Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
  1. * Prior surgery for this cancer
  2. * A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.
  3. * Currently receiving any other investigational agents.
  4. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
  5. * Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.
  6. * Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Contacts and Locations

Study Contact

Rebecca L Aft, M.D., Ph.D.
CONTACT
314-747-0063
aftr@wustl.edu
Tracie Guthrie
CONTACT
314-747-4404
guthriet@wustl.edu

Principal Investigator

Rebecca L Aft, M.D, Ph.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Rebecca L Aft, M.D, Ph.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

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 Date2017-01-17
Study Completion Date2031-07-31

Study Record Updates

Study Start Date2017-01-17
Study Completion Date2031-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer
  • Cancer of Breast
  • Breast Neoplasms
  • Cancer of the Breast