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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Neoplasms; Cancer of Breast; Cancer of the Breast
• Intervention / Treatment: Drug: Tamoxifen; Drug: Fulvestrant; Drug: Anastrozole; Drug: Exemestane; Drug: Goserelin; Behavioral: FACT-B; Other: Archived tissue collection

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rebecca L Aft, M.D., Ph.D.; Phone Number: 314-747-0063; Email: aftr@wustl.edu
• Study Contact Backup: Name: Tracie Guthrie; Phone Number: 314-747-4404; Email: guthriet@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Tracey Guthrie; Phone Number: 314-747-4404; Email: guthriet@wustl.edu
      • Contact: Rebecca L Aft, M.D., Ph.D.; Phone Number: 314-747-0063; Email: aftr@wustl.edu
      • Principal Investigator: Rebecca L Aft, M.D., Ph.D.
      • Sub-Investigator: Ron Bose, M.D., Ph.D.
      • Sub-Investigator: Cynthia X Ma, M.D., Ph.D.
      • Sub-Investigator: Katherine N Weilbaecher, M.D.
      • Sub-Investigator: Antonella Rastelli, M.D.
      • Sub-Investigator: Fei Wan, Ph.D.
      • Sub-Investigator: Peter Oppelt, M.D.
      • Sub-Investigator: Rama Suresh, M.D.
      • Sub-Investigator: William Gillanders, M.D.
      • Sub-Investigator: Caron Rigden, M.D.
      • Sub-Investigator: Julie Margenthaler, M.D.
      • Sub-Investigator: Lindsay Peterson, M.D.
      • Sub-Investigator: Foluso Ademuyiwa, M.D.
      • Sub-Investigator: Andrew Davis, M.D.
      • Sub-Investigator: Ashley Frith, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 68 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0.
• Disease must be ER+ and HER2-.
• Ki67 score/proliferative index ≤ 30% or low to intermediate mitotic index
• Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.
• 70 years of age or older.
• ECOG performance status ≤ 3
• Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

• Prior surgery for this cancer
• A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.
• Currently receiving any other investigational agents.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
• Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endocrine therapy alone; Neoadjuvant endocrine therapy will be given at the discretion of the treating physician as directed by the package insert and could include the following: goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen; Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment; After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy; Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire; Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment)

Drug: Tamoxifen; Other Names: Nolvadex®; Drug: Fulvestrant; Other Names: Faslodex®; Drug: Anastrozole; Other Names: Arimidex®; Drug: Exemestane; Other Names: Aromasin®; Drug: Goserelin; Other Names: Zoladex; Goserelin acetate; Behavioral: FACT-B; The FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms/concerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness).; Other: Archived tissue collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009].; In each RECIST response category Oncotype DX scores will be summarized with mean, standard deviation, minimum, 1st, 2nd (median) and 3rd quartiles, and maximum values. OncotypeDx scores range from 0 to 100, with scores <18 indicating low risk.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Breast cancer-specific survival	6 months
Breast cancer-specific survival	1 year
Breast cancer-specific survival	2 years
Rate of overall survival	5 years

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Genomic Health®, Inc.
• Investigators: Principal Investigator: Rebecca L Aft, M.D, Ph.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: June 17, 2015
• First Posted (Estimated): June 19, 2015

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence; 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; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Estrogen Receptor Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Fulvestrant; Goserelin; Tamoxifen; Anastrozole; Exemestane
• Other Study ID Numbers: 201611010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No