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

NCT ID: NCT02476786

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-17
• Study Completion Date: 2032-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

FACT-B

Intervention Type: 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).

Goserelin

Intervention Type: DRUG

Anastrozole

Intervention Type: DRUG

Exemestane

Intervention Type: DRUG

Fulvestrant

Intervention Type: DRUG

Tamoxifen

Intervention Type: DRUG

Archived tissue collection

Intervention Type: OTHER

Interventions

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).

Intervention Type: BEHAVIORAL

Goserelin

Intervention Type: DRUG

Anastrozole

Intervention Type: DRUG

Exemestane

Intervention Type: DRUG

Fulvestrant

Intervention Type: DRUG

Tamoxifen

Intervention Type: DRUG

Archived tissue collection

Intervention Type: OTHER

Other Intervention Names

Goserelin acetate; Zoladex; Arimidex®; Aromasin®; Faslodex®; Nolvadex®

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genomic Health®, Inc.

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

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

Role: CONTACT

aftr@wustl.edu

314-747-0063

Tracie Guthrie

Role: CONTACT

guthriet@wustl.edu

314-747-4404

Facility Contacts

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

Role: primary

aftr@wustl.edu

314-747-0063

Tracey Guthrie

Role: backup

guthriet@wustl.edu

314-747-4404

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

201611010

Identifier Type: -

Identifier Source: org_study_id