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Endocrine Treatment Alone for Elderly Patients With ER+ Breast Cancer

This study is looking at whether endocrine therapy alone can effectively treat breast cancer in women aged 70 or older. You might be eligible if you have newly diagnosed, operable breast cancer that is Estrogen Receptor positive (ER+) and HER2 negative, with a low Ki67 score (a measure of how fast cancer cells are growing). The study is testing drugs like Goserelin, Anastrozole, Exemestane, and Fulvestrant. Researchers want to see how well these treatments work after 6 months. The goal is to find out if these women can avoid more intensive treatments while still controlling their cancer. The current status of this study is unclear.

Study design
This interventional study plans to enroll 50 women. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, response rate, is measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02476786

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

Recruiting
PHASE2Ages 70+InterventionalTreatment
Washington University School of Medicine
~50 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:FACT-BGoserelinAnastrozoleExemestaneFulvestrantTamoxifen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response rate
Measured over 6 months

Conditions

Breast Cancer
Cancer of Breast
Breast Neoplasms
Cancer of the Breast

Explore related trials

Breast CarcinomaMKI67 Gene

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

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

Who to contact

Rebecca L Aft, M.D., Ph.D.
[email protected]
314-747-0063
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Response rate6 months

    * 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.