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Selective Estrogen Receptor Modulator
Endoxifen for Estrogen Receptor-Positive Breast Cancer
Phase 1
Waitlist Available
Led By Matthew P Goetz
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capable of understanding investigational nature, potential risks and benefits of the study and able to provide written informed consent
At least one prior hormone containing regimen in the metastatic setting (tamoxifen if pre-menopausal; aromatase inhibitor if post-menopausal)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study entry to death due to any cause, assessed up to 3 months
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of Z-endoxifen to treat patients with ER+ breast cancer. Z-endoxifen may fight breast cancer by blocking the use of estrogen by tumor cells.
Who is the study for?
This trial is for postmenopausal women with ER+ metastatic or locally recurrent breast cancer. Participants must have had prior hormone therapy, be able to swallow capsules, and have a life expectancy over 16 weeks. They should not have uncontrolled brain metastases, recent seizures, active blood clots, or other severe diseases that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing Z-endoxifen hydrochloride's safety and optimal dosage in patients whose breast cancer grows in response to estrogen. It includes lab biomarker analysis and pharmacological studies along with questionnaires about patient experiences.See study design
What are the potential side effects?
Potential side effects of Z-endoxifen hydrochloride may include reactions similar to those seen with other hormone therapies such as hot flashes, fatigue, joint pain, and an increased risk of blood clots. The exact side effects will be studied as part of the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study's risks and benefits and can give written consent.
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I have had hormone therapy for cancer that has spread, using tamoxifen or an aromatase inhibitor.
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My cancer can be measured or seen on tests.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is estrogen receptor positive.
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I can swallow 20-mg capsules.
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My breast cancer has spread or come back in the same area.
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I have had at least one chemotherapy treatment before.
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I am a woman who has gone through or is going through menopause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study entry to death due to any cause, assessed up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study entry to death due to any cause, assessed up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Change in hot flash scores graded using a hot flash diary and the hot flash interference scale
Overall survival
Progression-free survival
Other outcome measures
Change in tumor expression levels of AKT
Change in tumor expression levels of HER2
Change in tumor expression levels of IGF1R
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Z-endoxifen hydrochloride)Experimental Treatment4 Interventions
Patients receive Z-endoxifen hydrochloride PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,091 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Matthew P GoetzPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
319 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study's risks and benefits and can give written consent.I started hormonal therapy less than 3 weeks ago.I have had hormone therapy for cancer that has spread, using tamoxifen or an aromatase inhibitor.Your platelet count is at least 75,000 per microliter of blood.I have not had any HER2-targeted therapy in the last 3 weeks.Your creatinine level is not more than 1.5 times the normal level for the testing facility.I haven't received monoclonal antibodies in the last 3 weeks.I have not had a deep vein thrombosis or pulmonary embolism in the last year.I have had unusual bleeding from my uterus in the last year.I have not had a seizure in the last 3 months.I still have side effects from my last chemotherapy, except for stable grade 2 neuropathies.I am not currently on any other cancer treatments or experimental drugs.My cancer can be measured or seen on tests.You are expected to live for more than 16 weeks.I am fully active or restricted in physically strenuous activity but can do light work.Your bilirubin levels are not higher than 1.5 times the normal limit set by the hospital.My tumor can be easily reached for a biopsy.I have a history of blood clotting disorders.I have had 2 or more blood clots in the last 5 years.You have a condition called crystalline retinopathy.Your AST and ALT levels in your blood are not more than 2.5 times the normal levels, unless the high levels are caused by cancer spread to the liver.I am of childbearing age and do not plan to use birth control.I have not had radiation therapy in the last 3 weeks.You are currently breastfeeding.My cancer affects my spinal cord or heart.I have brain metastases that are not under control.My cancer is estrogen receptor positive.I have had any number of previous systemic treatments.You are required to participate in additional research activities.I can swallow 20-mg capsules.I need surgery soon for my cataracts.I haven't had any cancer except for non-melanoma skin cancer or cervical carcinoma-in-situ in the last 2 years.I haven't had chemotherapy in the last 3 weeks.I have not had biologic therapy in the last 3 weeks.I have not had immunotherapy in the last 3 weeks.I have previously been treated with endoxifen.I have not had a stroke in the last 6 months.I am currently on blood thinners for a clot in my veins or lungs.I plan to start or have recently started treatment with bisphosphonates or denosumab.I do not have any severe illnesses that could interfere with the study.My breast cancer has spread or come back in the same area.You have enough infection-fighting white blood cells in your body.I have HER2 positive cancer and it has worsened despite treatment with drugs like trastuzumab or lapatinib.I have had at least one chemotherapy treatment before.Women who could possibly become pregnant must have a recent negative pregnancy test.I am a woman who has gone through or is going through menopause.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Z-endoxifen hydrochloride)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Endoxifen Hydrochloride been authorized by the Food and Drug Administration?
"Since it is only in Phase 1, the safety of Endoxifen Hydrochloride received a score of 1 due to limited evidence backing its effectiveness and safety."
Answered by AI
Is enrollment available to volunteers for this experiment?
"According to information on clinicaltrials.gov, this medical trial is not in the process of recruiting at present. Originally posted on March 25th 2011 and last updated July 27th 2022, it does not appear that any new participants are being sought for the experiment. However, there are other 2,292 trials actively seeking patients right now."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Arizona
What portion of applicants met pre-screening criteria?
Met criteria
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