Endocrine Treatment for Older Women with Breast Cancer
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
Recruiting
Phase 2Interventional Study
Breast CancerCancer of BreastBreast NeoplasmsCancer of the Breast
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
70 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Washington University School of Medicine · Other
Who this trial is looking for
This trial is looking for older women with certain types of breast cancer who want to treat their condition with hormone therapy instead of surgery. Participants will receive endocrine therapy to control their cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I have recently been diagnosed with operable breast cancer.
My breast cancer is estrogen receptor positive (ER+).
I am 70 years old or older.
I can understand and sign a consent form.
My cancer has a low Ki67 score or low to intermediate mitotic index.
I have measurable disease.
My overall health status is acceptable for this study.
You may not be able to join if
I have had surgery for this breast cancer before.
I have a history of another cancer within the last 5 years.
I am currently taking any investigational drugs.
I have allergies to any drugs similar to those used in this study.
I have an uncontrolled illness that might affect my study participation.
I am known to be HIV positive and on combination antiretroviral therapy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 recepto…
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.
Trial Locations
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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 th…
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.
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