TER-ZLDX-0101 Trial for Advanced-Stage Breast Cancer
Updated on March 26, 2026
Overview: This trial is studying how well Zoladex (chemical name: goserelin) suppresses ovarian function during treatment for advanced-stage hormone receptor-positive, HER2-negative breast cancer. Ovarian suppression will be tested by measuring women’s estrogen levels every six weeks during the study.
Phase: Phase I trials are the first clinical trials to test a new treatment in people. Phase I trials are relatively small, usually about 15 to 50 people. In phase I trials, researchers are figuring out the best way to give a new treatment (such as by injection or as a pill) as well as the highest dose that can be given safely, without serious side effects.
Number of people to enroll: 88
ClinicalTrials.gov ID number: NCT07310420
Sponsor of the trial: TerSera Therapeutics LLC
Who is the trial for?
The trial is enrolling pre-menopausal women ages 18 to 55 who have been diagnosed with advanced-stage hormone receptor-positive, HER2-negative advanced-stage breast cancer that can’t be removed with surgery.
Why is the trial being done?
The trial is designed to see how effectively Zoladex stops the ovaries from producing hormones. Zoladex is an LHRH (luteinizing hormone-releasing hormone) agent. LHRHs shut down the ovaries and stop them from producing estrogen. Stopping the ovaries from producing estrogen can slow the growth of hormone receptor-positive breast cancer.
In the study, women will be given Zoladex in two doses, 12 weeks apart. Zoladex is a small pill, about the size of a grain of rice, that is injected under the skin and then dissolves slowly over time.
The researchers will check the women’s estrogen levels and ask about their menstrual periods at weeks 6, 12, 18, and 24 of the study.
Specific eligibility requirements
Women are eligible for the study if they:
are 18 to 55 years old and have not gone through menopause
have advanced-stage or metastatic breast cancer that is hormone receptor-positive and HER2-negative
have not previously taken Zoladex or medicines like it, such as Lupron (chemical name: leuprolide), or have taken one for less than six months
agree to take steps to avoid becoming pregnant and have negative results on two pregnancy tests, one done when they join the study and one done on the day before the first treatment
People are not eligible for this trial if they:
are post-menopausal
are pregnant or breastfeeding
have had their ovaries removed or have had radiation treatment to their ovaries
are significantly over- or underweight, defined as having a BMI of over 35 or under 18
have had radiation therapy for breast cancer within the past four weeks
are taking tamoxifen or another selective estrogen receptor modulator (SERM) medicine during the trial (women who stop taking the SERM can participate in the trial); women taking an aromatase inhibitor, or receiving Faslodex (chemical name: fulvestrant), a CDK4/6 inhibitor, or a PIK3CA inhibitor like Piqray (chemical name: alpelisib) or Itovebi (chemical name: inavolisib) are able participate in the study.
have any other life-threatening disease, or have another cancer or serious liver, kidney, blood, or heart problems
have serious allergies to drugs or food, or any allergies that have caused serious anaphylactic reactions
have been addicted to alcohol or drugs within the past year
Read the detailed eligibility criteria.
Side effects
The most common side effects of Zoladex are:
irregular periods or loss of periods
Study locations
This study is being conducted at one U.S. location, Michigan Hematology Oncology Associates, in Royal Oak, Michigan.
For more information or to enroll
Fill out the form on the Profound Research Ter-ZLDX-0101 page.
This content is made possible, in part, by TerSera Therapeutics.