Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Rece… (NCT01327781) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
United States62 participantsStarted 2011-03-25
Plain-language summary
This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has come back at or near the same place as the original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells. Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use of estrogen by tumor cells.
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:
* Histologically confirmed diagnosis of metastatic or locally recurrent breast cancer
* ER positive defined as \> 1% nuclear staining on the biopsy that was obtained at the confirmation of metastatic or locally recurrent disease
* Lesion type of either evaluable or measurable disease
* Pre- or post-menopausal female
* For the expansion cohorts: tumor that is accessible for biopsy
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Life expectancy \> 16 weeks
* Capable of understanding investigational nature, potential risks and benefits of the study and able to provide written informed consent
* Absolute neutrophil count (ANC) \>= 1,000/uL
* Platelet count \>= 75,000/uL
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (\< 5 x institutional ULN if liver function test \[LFT\] elevations due to liver metastases)
* Creatinine =\< 1.5 x institutional ULN
* Women with human epidermal growth factor (HER)-2 positive disease must have received and progressed on at least one prior anti-HER-2 directed regimen (trastuzumab, lapatinib) for their metastatic disease
* For dose escalation cohort:
* Any number of prior systematic therapy regimens is allowed
* NOTE: prior systematic therapy in the adjuvant setting is n…
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 1 trial primarily focused on finding the maximum tolerated dose of Z-Endoxifen, what does that mean for what's currently known about whether it actually helps shrink tumors or slow progression in my specific situation?
2Given that this trial is 'active but not recruiting,' is there any chance my doctor could still get me access to Z-Endoxifen through a compassionate use or expanded access program outside this trial?
3Because the trial is designed around identifying dose-limiting toxicities, what kinds of side effects have been observed so far in patients who received Z-Endoxifen, and how would those compare to the side effects I might expect from standard hormone therapies for estrogen receptor-positive breast cancer?
4My cancer is listed as HER2/Neu positive — does that affect how likely Z-Endoxifen might work for me, or how it interacts with any HER2-targeted treatments I might already be receiving?
5Before considering a Phase 1 dose-finding study like this one, are there standard approved treatments or other clinical trials I should try first that have more established safety and effectiveness data for metastatic estrogen receptor-positive breast cancer?
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.
What they're measuring
1
MTD defined as the highest dose level where at most 1 of 6 patients develops a dose limiting toxicity and 2 or more of the 3-6 patients treated at the next higher dose level develop a dose limiting toxicity