Endocrine therapy for older women with operable breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of endocrine therapy alone in elderly women aged 70 and older who have estrogen receptor positive (ER+) operable breast cancer with low recurrence scores. The study aims to determine if this treatment approach can provide adequate local and systemic control of breast cancer without the need for additional interventions. Participants will receive treatments such as Goserelin, Anastrozole, Exemestane, and Fulvestrant, with the goal of establishing a new standard of care for this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Rebecca L Aft, M.D, Ph.D. — Washington University School of Medicine
• Study coordinator: Rebecca L Aft, M.D., Ph.D.
• Email: aftr@wustl.edu
• Phone: 314-747-0063

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.