(Z)-Endoxifen for Premenopausal ER+/HER2- Breast Cancer
This study is looking at (Z)-endoxifen as a potential treatment for premenopausal women with a specific type of breast cancer (ER+/HER2-). (Z)-endoxifen is a type of drug called a SERM, which helps block estrogen from attaching to cancer cells. You may be eligible if you are a woman aged 18 or older with this type of breast cancer, are not pregnant, and meet other criteria. The study aims to see how your body processes (Z)-endoxifen and if it can effectively reduce cancer cell growth or shrink tumors. Some participants will receive (Z)-endoxifen alone, while others will also receive goserelin, a drug that temporarily stops the ovaries from making estrogen. The current recruitment status is unclear.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll about 87 participants and has two parts: one to study how the body processes the drug and another to evaluate its treatment effects.
- What's involved
- You will take (Z)-endoxifen capsules daily. Some participants will also receive a monthly injection of goserelin. The study will measure drug levels after 4 weeks and tumor response after 24 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure tumor response after 24 weeks of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
At a glance
Conditions
Where it's being run
14 sites across 13 statesStudy leadership
- Matthew P Goetz, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- PK Cohort - (Z)-endoxifen steady-state plasma concentrationsAfter 4 weeks of treatment
(Z)-endoxifen steady-state plasma concentrations (Css) of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- For Analysis of Cohort A (Treatment Cohort): determine whether the week 4 Ki-67≤10% rate is at least 65%After 4 weeks of treatment
For analysis Cohort A (subjects that have a baseline Ki-67\>10%): the primary objective is to determine whether the Week 4 Ki-67 ≤ 10% rate is at least 65% among premenopausal women with primary estrogen receptor positive (ER+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
- For analysis Cohort B (Treatment Cohort): determine the objective tumor response rate at 24 weeksAfter 24 weeks of treatment
For analysis Cohort B (subjects have baseline Ki-67≤ 10%): the primary objective is to determine the objective tumor response rate at 24 weeks among premenopausal women with ER+, HER2-, Ki-67 ≤ 10% breast cancer receiving (Z) endoxifen plus goserelin.