Endocrine therapy for older women with operable breast cancer

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

This study is testing if hormone therapy alone can effectively treat older women with early-stage breast cancer, so they might not need extra treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 70 Years and up
• Sex: Female
• Sponsor: Washington University School of Medicine (other)
• Locations: 1 site (St Louis, Missouri)
• Trial ID: NCT02476786 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 70 or older with newly diagnosed operable ER+ breast cancer and low Ki67 scores.

Not a fit: Patients with a history of other malignancies or those who have undergone prior surgery for breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could allow elderly patients to manage their breast cancer effectively without undergoing more invasive treatments.

How similar studies have performed: Previous studies have shown promise in using neoadjuvant endocrine therapy for similar patient populations, suggesting potential success for this approach.

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.

Where this trial is running

St Louis, Missouri

• 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.

Conditions: Breast Cancer, Cancer of Breast, Breast Neoplasms, Cancer of the Breast