Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
Phase I Study of Z-Endoxifen as a Hormonal Therapy for Breast Cancer
8 other identifiers
interventional
62
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2011
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2011
CompletedFirst Submitted
Initial submission to the registry
March 31, 2011
CompletedFirst Posted
Study publicly available on registry
April 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
ExpectedApril 13, 2026
February 1, 2026
6 years
March 31, 2011
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (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
Assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The maximum grade of each type of toxicity will be recorded for each patient. For each toxicity reported by dose level, the percentage of patients developing any degree of that toxicity as well as the percentage of patients developing a severe degree (grade 3 or higher) will be determined.
28 days
Secondary Outcomes (3)
Progression-free survival
From study entry to the documentation of disease progression, assessed up to 3 months
Overall survival
From study entry to death due to any cause, assessed up to 3 months
Change in hot flash scores graded using a hot flash diary and the hot flash interference scale
Baseline to day 28
Other Outcomes (11)
Change in tumor expression levels of SRC3
Baseline up to day 28
Change in tumor expression levels of SRC1
Baseline up to day 28
Change in tumor expression levels of IGF1R
Baseline up to day 28
- +8 more other outcomes
Study Arms (1)
Treatment (Z-endoxifen hydrochloride)
EXPERIMENTALPatients receive Z-endoxifen hydrochloride PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- 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:
- +22 more criteria
You may not qualify if:
- Any of the following therapies prior to registration:
- Chemotherapy =\< 3 weeks
- Immunotherapy =\< 3 weeks
- Biologic therapy =\< 3 weeks
- Hormonal therapy =\< 3 weeks
- Monoclonal antibodies =\< 3 weeks
- Radiation therapy =\< 3 weeks
- Anti-Her-2 directed therapy =\< 3 weeks
- Prior endoxifen therapy
- Prior history of:
- Stroke =\< 6 months prior to registration
- Seizures =\< 3 months prior to registration
- Deep vein thrombosis (DVT) or pulmonary embolism (PE) =\< 12 months prior to registration
- Two or more episodes of DVT and/or PE =\< 5 years prior to registration
- Crystalline retinopathy
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew P Goetz
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2011
First Posted
April 4, 2011
Study Start
March 25, 2011
Primary Completion
March 5, 2017
Study Completion (Estimated)
October 30, 2026
Last Updated
April 13, 2026
Record last verified: 2026-02