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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02476786
• Other study ID #: 201611010
• Status: Recruiting
• Phase: Phase 2
• Start date: January 17, 2017
• Est. completion date: January 31, 2030

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: Rebecca L Aft, M.D., Ph.D.
• Phone: 314-747-0063
• Email: aftr[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2030
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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).

Drug:
• Goserelin

• Anastrozole

• Exemestane

• Fulvestrant

• Tamoxifen

Other:
• Archived tissue collection

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Genomic Health®, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Breast cancer-specific survival		6 months
Secondary	Breast cancer-specific survival		1 year
Secondary	Breast cancer-specific survival		2 years
Secondary	Rate of overall survival		5 years

External Links

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