Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Ca… (NCT02476786) | Clinical Trial Compass
RecruitingPhase 2
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
United States50 participantsStarted 2017-01-17
Plain-language summary
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.
Who can participate
Age range
70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.