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

NOT_YET_RECRUITINGPHASE1

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

NCT07310420•TerSera Therapeutics LLC

View on ClinicalTrials.gov

Summary

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

Detailed Description

The purpose of this study is to assess the degree and consistency of ovarian suppression achieved following administration of ZOLADEX 10.8 mg. Ovarian suppression will be evaluated by measuring LH levels over the treatment period.

Eligibility

Age

18 - 55 years

Sex

FEMALE

Healthy Volunteers

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.
+41 more criteria

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.
+1 more criteria

Locations (3)

Duly Health and Care

Lisle, Illinois, United States

Presence Infusion Care

Skokie, Illinois, United States

Profound Research LLC at Michigan Hematology and Oncology Consultants

Royal Oak, Michigan, United States

Key Dates

Start Date

April 29, 2026

Primary Completion Date

November 30, 2026

Completion Date

March 30, 2027

Last Updated

March 11, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Breast Cancer

Interventions

ZOLADEX

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers