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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jun 17, 2015

Keywords

ClinConnect Summary

This clinical trial is exploring whether treating elderly women with estrogen receptor-positive (ER+) breast cancer using only endocrine therapy—medications that block hormones—can effectively control their cancer without needing additional treatments like surgery or chemotherapy. The researchers believe that for women aged 70 and older with early-stage breast cancer that has a low risk of recurrence, this approach may be just as effective and less invasive.

To participate in this trial, women must be at least 70 years old, have a confirmed diagnosis of operable ER+ breast cancer, and meet certain health criteria. Participants will receive endocrine therapy alone and will be monitored closely to see how well it works in controlling their cancer. This study is currently recruiting participants, and anyone interested should talk to their doctor to see if they qualify.

Gender

FEMALE

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.