Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Meta… (NCT02311933) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
United States81 participantsStarted 2015-05-28
Plain-language summary
This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body and has estrogen receptors but not human epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in treating patients with breast cancer.
Who can participate
Age range
18 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:
* PRE-REGISTRATION ELIGIBILITY CRITERIA
* Women who agree to undergo a standard of care core biopsy of recurrent or metastatic breast cancer to confirm the ER+ (\>= 10% nuclear staining) and HER2 negative status
* Patient must have been previously treated with an aromatase inhibitor (either letrozole, anastrozole or exemestane) either in the adjuvant or metastatic setting, and have one of the following types of primary or secondary endocrine resistant disease
* Primary clinical resistance is defined as one of the following:
* Recurrence within the first 2 years of adjuvant endocrine therapy while on aromatase inhibitor therapy
* Progression within first 6 months of initiating first-line endocrine therapy (either aromatase inhibitor or fulvestrant containing regimen) for the treatment of metastatic breast cancer
* Secondary clinical resistance is defined as one of the following:
* Recurrence after year 2 while receiving adjuvant aromatase inhibitor therapy, or within 12 months of completing adjuvant aromatase inhibitor therapy
* Progression occurring 6 or more months after initiating the first endocrine therapy for metastatic disease (either fulvestrant or aromatase inhibitor containing regimen)
* Patients with a history of measurable disease as defined by RECIST criteria or bone only disease are eligible; Note: those patients with non-measurable disease and bone metastases are eligible
* No history of tumors involving spinal cord or…
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.
1Since this is a Phase 2 trial comparing tamoxifen — which is already an established treatment — to Z-Endoxifen, what does my doctor think is currently known about the safety profile of Z-Endoxifen compared to standard tamoxifen, given that Phase 2 studies are still building that evidence?
2The trial is measuring progression-free survival as its main outcome, meaning how long the cancer stays stable — can my doctor explain what that would realistically mean for my specific stage, whether Stage III or Stage IV, and how that compares to what I might expect from other available options?
3Since this trial is active but no longer recruiting new patients, does my doctor know if there are any updated results or data available from it that could inform my treatment decision right now?
4Z-Endoxifen is being tested partly because some patients don't convert tamoxifen effectively in their body — would my doctor recommend genetic testing to see how I metabolize tamoxifen before deciding whether a trial like this or standard tamoxifen would make more sense for me?
5Given that my cancer is estrogen receptor-positive and HER2-negative, how does this trial fit alongside other current standard-of-care options like CDK4/6 inhibitors combined with hormonal therapy, and would my doctor consider those alternatives first or instead?
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.