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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer

Phase 1 Single-arm, Open-label, Multicenter Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer

A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer (NCT07310420) is a Phase 1 interventional studying Advanced Breast Cancer, sponsored by TerSera Therapeutics LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Breast Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 88 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Breast Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age and gender: 1. Gonadotropin-releasing Hormone (GnRH) treatment-naïve: Female participants aged 18 to 55 years, inclusive. 2. GnRH treatment-exposed \<6 months: Female participants aged 18 to 55 years, inclusive, if GnRH treatment started within \<6 months of signing the willing to sign a consent form. 2. Advanced or metastatic breast cancer: Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent per investigator's assessment. 3. HR+: Either estrogen receptor positive (ER+) or progesterone receptor positive (PR+) breast cancer, defined as 1% to 100% of tumor nuclei are positive for ER or PR via immunohistochemistry. 4. HER2-: Via American Society of Clinical Oncology, College of American Pathology (ASCO-CAP) guidelines. 5. Prior treatment: 1. Participants may have received prior radiotherapy. 2. Participants may have received or be receiving a cyclin-dependent kinase (CDK) 4/6 inhibitor, a phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha-protein kinase B (PIK3CA-AKT) inhibitor, or bisphosphonates if initiated and at a stable dose for at least 2 weeks before trial enrollment. 3. GnRH treatment-naïve participants will have no history of GnRH agonist or other endocrine therapy in the advanced/metastatic setting. 4. GnRH treatment-exposed participants may have received a GnRH agonist or other endocrine therapy provided they had established premenopausal status prior to initiating GnRH agonist therapy, within 6 months prior to trial enrollment. 6. Chemotherapy History: a. A participant may have received adjuvant or neoadjuvant chemotherapy in early-stage breast cancer. i. Any participant who received prior adjuvant or neoadjuvant chemotherapy are eligible provided the criteria for premenopausal status. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age and gender: 1. Gonadotropin-releasing Hormone (GnRH) treatment-naïve: Female participants aged 18 to 55 years, inclusive. 2. GnRH treatment-exposed \<6 months: Female participants aged 18 to 55 years, inclusive, if GnRH treatment started within \<6 months of signing the informed consent. 2. Advanced or metastatic breast cancer: Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent per investigator's assessment. 3. HR+: Either estrogen receptor positive (ER+) or progesterone receptor positive (PR+) breast cancer, defined as 1% to 100% of tumor nuclei are positive for ER or PR via immunohistochemistry. 4. HER2-: Via American Society of Clinical Oncology, College of American Pathology (ASCO-CAP) guidelines. 5. Prior treatment: 1. Participants may have received prior radiotherapy. 2. Participants may have received or be receiving a cyclin-dependent kinase (CDK) 4/6 inhibitor, a phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha-protein kinase B (PIK3CA-AKT) inhibitor, or bisphosphonates if initiated and at a stable dose for at least 2 weeks before trial enrollment. 3. GnRH treatment-naïve participants will have no history of GnRH agonist or other endocrine therapy in the advanced/metastatic setting. 4. GnRH treatment-exposed participants may have received a GnRH agonist or other endocrine therapy provided they had established premenopausal status prior to initiating GnRH agonist therapy, within 6 months prior to trial enrollment. 6. Chemotherapy History: a. A participant may have received adjuvant or neoadjuvant chemotherapy in early-stage breast cancer. i. Any participant who received prior adjuvant or neoadjuvant chemotherapy are eligible provided the criteria for premenopausal status. b. All chemotherapy-related toxicities must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 ≤Grade 1 before trial participation, except for alopecia, peripheral neuropathy, or paresthesia (≤Grade 2). 7. Concurrent Medications: 1. Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are permitted if initiated and tolerated without ongoing toxicity CTCAE v6.0 \>Grade 1 for at least 2 weeks before trial enrollment. 2. PIK3CA/AKT inhibitors are permitted if started at least 2 weeks before the trial and tolerated without ongoing toxicity CTCAE v6.0 \>Grade 1. 3. Concomitant use of bisphosphonates is permitted if initiated and tolerated without ongoing toxicity CTCAE v6.0 \>Grade 1 for at least 2 weeks before trial enrollment. 4. Concomitant use of endocrine therapy (eg, aromatase inhibitor, fulvestrant, or other FDA-approved selective estrogen receptor degraders \[SERDs\]) is permitted. 8. Informed consent: Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions. 9. Contraceptive use: Female participants may be enrolled if they are: 1. Practicing true abstinence for at least 28 days prior to investigational product (IP) administration until 30 days after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, OR 2. Using 2 forms of highly effective nonhormonal contraception, including 1 physical barrier (condom or diaphragm) plus another nonhormonal method (eg, intrauterine device, spermicidals) from Screening or at least 2 weeks prior to IP administration (whichever is earlier) until 30 days after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1. 10. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: 1. Postmenopausal: Naturally or surgically postmenopausal (regardless of age). 2. Body mass index (BMI): \<18 kg/m\^2 or \>35.0 kg/m\^2. 3. Prior surgical or radiation procedures: History of bilateral oophorectomy or prior radiotherapy to the ovaries. 4. Recent radiotherapy: 1. Radiotherapy for breast cancer within 4 weeks prior to trial enrollment. 2. All radiotherapy-related toxicities (except alopecia) must have recovered to CTCAE v6.0 ≤Grade 1 before trial enrollment. 5. Radiotherapy during trial: Planned radiotherapy during trial period. 6. Selective estrogen receptor modulator (SERM) use during trial: Participants may not receive tamoxifen or other SERMs during the trial and must discontinue any SERMs prior to enrollment, other endocrine therapies (eg, aromatase inhibitor, fulvestrant, or other FDA-approved SERDs) are allowed. 7. Hypersensitivity: Known hypersensitivity, idiosyncratic, or allergic reactions to goserelin, GnRH, GnRH agonists/analogs, or any trial drug components. 8. Expected survival: Estimated life expectancy \<6 months from the start of trial therapy, based on the principal investigator's (PI) clinical judgment. 9. Performance status: ECOG performance status ≥3. 10. Life-threatening disease or metastasis: Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, symptomatic pulmonary lymphangitic spread, symptomatic pleural disease, or any symptomatic brain/leptomeningeal metastases (proven or suspected). Participants with asymptomatic or stable/treated brain metastases are eligible to enroll if neurologically stable and are receiving a stable or decreasing corticosteroid dose at the time of enrollment. Participants with discrete pulmonary parenchymal metastases are eligible if respiratory function is not compromised. 11. Hepatic function: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2×upper limit of normal (ULN) if no liver metastases, or \>5×ULN with liver metastases. 2. Total bilirubin ≥1.5×ULN (≥2.5×ULN for Gilbert's syndrome). 12. Renal function: Creatinine clearance (CrCl) ≤30 mL/min as calculated by the Cockcroft-Gault formula. 13. Hematologic parameters: 1. Hemoglobin (Hgb) \<8.0 g/dL. 2. White blood cell (WBC) count \<3000/mm\^3. 3. Platelets \<100,000/mm\^3. 14. Other malignancies: Active malignancy within the past 3 years, except for adequately treated basal or squamous cell skin cancer or in situ cervical carcinoma. 15. Concurrent medical conditions: Presence of any severe, uncontrolled, or serious illness, medical condition (including psychiatric/addictive disorders), or clinical finding that could compromise trial adherence, as assessed by the investigator. 16. Investigational drug exposure: Exposure to any investigational drug or device within 30 days prior to trial enrollment. 17. Pregnancy: Participant has childbearing potential with a positive serum pregnancy test or positive urine pregnancy test at Screening or Day 1. 18. Breastfeeding: Participant is currently breastfeeding. 19. Contraceptive use: Sexually active with a male partner and not willing to use nonhormonal contraceptive methods throughout the trial. Exceptions: male partner is vasectomized (provided he is her sole sexual partner, and he has received medical assessment of the surgical success), participant has had bilateral salpingectomy or tubal occlusion hysterectomy. 20. Cardiac conditions: 1. Corrected QT interval (QTc) using Fridericia's correction (QTcF) \>450 ms at Screening. 2. Uncontrolled or symptomatic heart disease, including: i. New York Heart Association (NYHA) Class III or IV heart failure. ii. Myocardial infarction within the past 6 months. iii. Unstable angina or significant arrhythmias requiring intervention. c. Documented congenital QT syndrome. 21. Clinically relevant abnormal medical history or abnormal findings on physical examination, vital signs, echocardiogram (ECG), or laboratory tests at Screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant. 22. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 23. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within the last 1 year prior to IP administration. 24. Major surgery within 30 days prior to IP dosing or a major surgical procedure planned during the trial. 25. Any other condition that precludes adequate understanding, cooperation, and compliance with trial procedures or any condition that could pose a risk to the participant's safety, as per the investigator's judgment.

Treatments Being Tested

DRUG

ZOLADEX

Participants will receive ZOLADEX as a subcutaneous (SC) injection on Day 1 (Week 1), and Day 85 (Week 12) for a total of 2 treatments.

Locations (11)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States
MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Cancer Centers of Florida
Ocoee, Florida, United States
Summit Cancer Care
Savannah, Georgia, United States
Duly Health and Care
Lisle, Illinois, United States
Orchard Healthcare Research
Skokie, Illinois, United States
Profound Research LLC at Michigan Hematology and Oncology Consultants
Royal Oak, Michigan, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
The Mark H. Zangmeister Center-Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States
Guthrie Medical Group
Sayre, Pennsylvania, United States
Oncology Consultants PA
Houston, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07310420), the sponsor (TerSera Therapeutics LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07310420 clinical trial studying?

The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07310420?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07310420?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07310420. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07310420. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.