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Selective Estrogen Receptor Modulator
Tamoxifen vs Endoxifen for Advanced Breast Cancer
Phase 2
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
Patient must have been previously treated with an aromatase inhibitor (letrozole, anastrozole, or exemestane) either in the adjuvant or metastatic setting, and have primary or secondary endocrine resistant disease
Patients with a history of measurable disease as defined by RECIST criteria or bone only disease are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial compares tamoxifen citrate to z-endoxifen hydrochloride in treating patients with breast cancer that has spread and has estrogen receptors but not human epidermal growth factor receptor 2 (HER2) receptors.
Who is the study for?
This trial is for postmenopausal women with advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer. Participants must have been treated previously with an aromatase inhibitor and can't be on strong CYP2D6 inhibitors or have had more than two chemotherapy treatments in the metastatic setting. They should not have brain metastases, uncontrolled illnesses, certain blood disorders, or a recent history of significant blood clots.Check my eligibility
What is being tested?
The study compares tamoxifen citrate and z-endoxifen hydrochloride to see which one is better at treating patients whose breast cancer has spread and relies on estrogen to grow. The trial includes lab biomarker analysis and pharmacological studies to assess how well these hormone therapies work.See study design
What are the potential side effects?
Potential side effects may include hot flashes, mood swings, changes in menstrual flow for premenopausal women (not applicable here as participants are postmenopausal), fatigue, vision problems like cataracts or retinopathy, risk of blood clots such as deep vein thrombosis/pulmonary embolism (especially important given the exclusion criteria), and possible liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was treated with an aromatase inhibitor for my cancer and it did not respond well.
Select...
My cancer can be measured by scans or is only in my bones.
Select...
I am not taking strong inhibitors of CYP2D6.
Select...
My breast cancer is confirmed to be estrogen receptor positive and HER2 negative.
Select...
My cancer is not HER2 positive according to specific guidelines.
Select...
I have fully recovered from the side effects of my previous treatments.
Select...
I agree to a biopsy to confirm my breast cancer is ER+ and HER2-.
Select...
I have gone through menopause.
Select...
I can take pills by mouth.
Select...
My cancer is estrogen receptor positive.
Select...
I have had 2 or fewer chemotherapy treatments for my cancer after it spread.
Select...
I haven't had any cancer other than non-melanoma skin cancer in the last 3 years.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer can be measured by scans or is only in my bones.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Incidence of Adverse Events, Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Upper arm
Tumor Response Rate by Study Arm, Defined as the Number of Patients With a Complete or Partial Response
Other outcome measures
Change in Biochemical Markers of Bone Turnover
DNA
Nuclear Receptor Coactivator 3 (SRC3) Immunohistochemistry Expression Levels
+4 moreSide effects data
From 2013 Phase 1 trial • 89 Patients • NCT0139399033%
Leukopenia
33%
Anaemia
33%
Lymphopenia
33%
Hypoxia
33%
Vomiting
33%
Chest discomfort
33%
Insomnia
33%
Neutropenia
33%
Nausea
33%
Chest pain
33%
Chills
33%
Decreased appetite
33%
Dizziness
33%
Cough
33%
Oropharyngeal pain
33%
Dry skin
33%
Pyrexia
33%
Stomatitis
33%
Palpitations
33%
Diarrhoea
33%
Dysphagia
33%
Tremor
33%
Respiratory tract congestion
33%
Bronchitis
33%
Fatigue
33%
Seasonal allergy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: 160 mg LY2228820 Capsules
Part D: 200 mg LY2228820 Tablets
Part D: 300 mg LY2228820 Tablets
Part A: 160 mg LY2228820 Bridge
Part A: 200 mg LY2228820 Tablets
Part A: 120 mg LY2228820 Capsules
Part A: 300 mg LY2228820 Tablets
Part A: 90 mg LY2228820 Capsules
Part A: 420 mg LY2228820 Tablets
Part C: 300 mg LY2228820 Tablets
Part A: 200 mg LY2228820 Capsules
Part A: 65 mg LY2228820 Capsules
Part A: 10 mg LY2228820 Capsules
Part A: 20 mg LY2228820 Capsules
Part A: 160 mg LY2228820 Tablets
Part A: 40 mg LY2228820 Capsules
Part B: 420 mg LY2228820 Tablets
Part A: 560 mg LY2228820 Tablets
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (tamoxifen citrate)Experimental Treatment3 Interventions
Patients receive tamoxifen citrate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression and bone metastases may cross over to Arm I and receive z-endoxifen hydrochloride starting no later than 28 days after documentation of disease progression.
Group II: Arm I (z-endoxifen hydrochloride)Experimental Treatment3 Interventions
Patients receive z-endoxifen hydrochloride PO on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,072 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Matthew P GoetzPrincipal InvestigatorAlliance for Clinical Trials in Oncology
3 Previous Clinical Trials
300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not postmenopausal.Your creatinine levels are higher than 1.5 times the normal range.Your AST levels are higher than the normal range, especially if you have cancer that has spread to your liver.I am not taking strong inhibitors of CYP2D6.I have not had any cancer other than non-melanoma skin cancer in the last 3 years.I cannot swallow pills.You do not have any of the listed other health problems.Your total bilirubin level is not more than 1.5 times the upper limit of normal.I have had more than two chemotherapy treatments for cancer that has spread.My cancer affects my spinal cord or heart.I was treated with an aromatase inhibitor for my cancer and it did not respond well.My breast cancer is confirmed to be estrogen receptor positive and HER2 negative.My cancer is not HER2 positive according to specific guidelines.I have had multiple hormone treatments for my cancer, possibly including everolimus or CDK 4/6 inhibitors.I am not taking strong inhibitors of CYP2D6.I need considerable assistance and am unable to carry out any work activities.My cancer has spread to my internal organs or lymph system.My cancer can be measured by scans or is only in my bones.I have not had a blood clot in my legs or lungs in the last 6 months.I have fully recovered from the side effects of my previous treatments.Your bilirubin levels are higher than the normal range.I do not have any unmanaged ongoing illnesses.I have cancer that has spread to my brain.I am currently not on treatments like chemotherapy, immunotherapy, or radiation.I agree to a biopsy to confirm my breast cancer is ER+ and HER2-.I have gone through menopause.Your platelet count is less than 75,000 per cubic millimeter.I do not have any untreated or uncontrolled illnesses.I can take pills by mouth.I have serious eye problems like advanced cataracts or retinopathy.I have not had a blood clot in my legs or lungs in the last 6 months.Your hemoglobin level is lower than 9 grams per deciliter.My cancer is estrogen receptor positive.I have had 2 or fewer chemotherapy treatments for my cancer after it spread.I haven't had any cancer other than non-melanoma skin cancer in the last 3 years.I can take care of myself and am up and about more than half of my waking hours.Your hemoglobin level is at least 9 grams per deciliter.Your platelet count is at least 75,000 per cubic millimeter.Your creatinine levels are not higher than 1.5 times the normal limit.Your AST levels must be within a certain range, and if you have liver metastasis, the range is slightly higher.My cancer can be measured by scans or is only in my bones.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (z-endoxifen hydrochloride)
- Group 2: Arm II (tamoxifen citrate)
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
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