← Back to Search

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)

Must not have

Anti-Her-2 directed therapy =< 3 weeks prior to registration

Monoclonal antibodies =< 3 weeks prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to day 56

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I understand the study's risks and benefits and can give written consent.

Select...

I have had hormone therapy for cancer that has spread, using tamoxifen or an aromatase inhibitor.

Select...

My cancer can be measured or seen on tests.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My cancer is estrogen receptor positive.

Select...

I can swallow 20-mg capsules.

Select...

My breast cancer has spread or come back in the same area.

Select...

I have had at least one chemotherapy treatment before.

Select...

I am a woman who has gone through or is going through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had any HER2-targeted therapy in the last 3 weeks.

Select...

I haven't received monoclonal antibodies in the last 3 weeks.

Select...

I have had unusual bleeding from my uterus in the last year.

Select...

I am not currently on any other cancer treatments or experimental drugs.

Select...

I have a history of blood clotting disorders.

Select...

I am of childbearing age and do not plan to use birth control.

Select...

My cancer affects my spinal cord or heart.

Select...

I have brain metastases that are not under control.

Select...

I need surgery soon for my cataracts.

Select...

I haven't had chemotherapy in the last 3 weeks.

Select...

I have not had immunotherapy in the last 3 weeks.

Select...

I have previously been treated with endoxifen.

Select...

I am currently on blood thinners for a clot in my veins or lungs.

Select...

I do not have any severe illnesses that could interfere with the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in hot flash scores graded using a hot flash diary and the hot flash interference scale

Other study objectives

Change in tumor expression levels of AKT

Change in tumor expression levels of HER2

Change in tumor expression levels of IGF1R

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 23Eligibility criteria met