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

NCT02476786 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 201611010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Cancer of Breast; Breast Neoplasms; Cancer of the Breast

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Breast cancer-specific survival

  6 months

• Breast cancer-specific survival

  1 year

• Breast cancer-specific survival

  2 years

• Rate of overall survival

  5 years

Study Arms (1)

Endocrine therapy alone

EXPERIMENTAL

* 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)

Behavioral: FACT-B; Drug: Goserelin; Drug: Anastrozole; Drug: Exemestane; Drug: Fulvestrant; Drug: Tamoxifen; Other: Archived tissue collection

Interventions

FACT-B BEHAVIORAL

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).

Endocrine therapy alone

Goserelin DRUG

Also known as: Goserelin acetate, Zoladex

Endocrine therapy alone

Anastrozole DRUG

Also known as: Arimidex®

Endocrine therapy alone

Exemestane DRUG

Also known as: Aromasin®

Endocrine therapy alone

Fulvestrant DRUG

Also known as: Faslodex®

Endocrine therapy alone

Tamoxifen DRUG

Also known as: Nolvadex®

Endocrine therapy alone

Archived tissue collection OTHER

Endocrine therapy alone

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Genomic Health®, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin; Anastrozole; exemestane; Fulvestrant; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Rebecca L Aft, M.D, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca L Aft, M.D., Ph.D.

CONTACT

314-747-0063; aftr@wustl.edu

Tracie Guthrie

CONTACT

314-747-4404; guthriet@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 19, 2015
• Study Start: January 17, 2017
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): July 31, 2032
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)