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

NCT07310420 | Recruiting Phase 1 FDA Drug

• 1 other identifier: TER-ZLDX-0101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Advanced Breast Cancer

Keywords

Ovarian Suppression; ZOLADEX; HR+; HER2-; Breast Cancer; Goserelin Implant

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with LH Values Below a Specified Threshold at Week 6

  Week 6

Secondary Outcomes (3)

• Percentage of Participants with LH Values below a Specified Threshold at Weeks 12, 18, and 24

  Weeks 12, 18, and 24

• Percentage of Participants with Estradiol (E2) Suppression at Weeks 6, 12, 18, and 24

  Weeks 6, 12, 18, and 24

• Percentage of Participants with Absence of Menses at Weeks 6, 12, 18, and 24

  Weeks 6, 12, 18, and 24

Study Arms (1)

ZOLADEX 10.8 mg

EXPERIMENTAL

Participants will receive 10.8 mg ZOLADEX on Day 1 and Day 85.

Drug: ZOLADEX

Interventions

ZOLADEX DRUG

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.

Also known as: Goserelin implant

ZOLADEX 10.8 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age and gender:
• Gonadotropin-releasing Hormone (GnRH) treatment-naïve: Female participants aged 18 to 55 years, inclusive.
• 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.
• 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.
• 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.
• HER2-: Via American Society of Clinical Oncology, College of American Pathology (ASCO-CAP) guidelines.
• Prior treatment:
• Participants may have received prior radiotherapy.
• 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.
• GnRH treatment-naïve participants will have no history of GnRH agonist or other endocrine therapy in the advanced/metastatic setting.
• 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.
• 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).

You may not qualify if:

• Postmenopausal: Naturally or surgically postmenopausal (regardless of age).
• Body mass index (BMI): \<18 kg/m\^2 or \>35.0 kg/m\^2.
• Prior surgical or radiation procedures: History of bilateral oophorectomy or prior radiotherapy to the ovaries.
• Recent radiotherapy:
• Radiotherapy for breast cancer within 4 weeks prior to trial enrollment.
• All radiotherapy-related toxicities (except alopecia) must have recovered to CTCAE v6.0 ≤Grade 1 before trial enrollment.
• Radiotherapy during trial: Planned radiotherapy during trial period.
• 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.
• Hypersensitivity: Known hypersensitivity, idiosyncratic, or allergic reactions to goserelin, GnRH, GnRH agonists/analogs, or any trial drug components.
• Expected survival: Estimated life expectancy \<6 months from the start of trial therapy, based on the principal investigator's (PI) clinical judgment.
• Performance status: ECOG performance status ≥3.
• 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.
• Hepatic function:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2×upper limit of normal (ULN) if no liver metastases, or \>5×ULN with liver metastases.
• Total bilirubin ≥1.5×ULN (≥2.5×ULN for Gilbert's syndrome).

Sponsors & Collaborators

• TerSera Therapeutics LLC: lead

Study Sites (15)

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, 71913, United States

RECRUITING

MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Cancer Centers of Florida

Ocoee, Florida, 34761, United States

RECRUITING

Summit Cancer Care

Savannah, Georgia, 31405, United States

RECRUITING

NorthShore University HealthSystem - Evanston Hospital

Evanston, Illinois, 60201, United States

RECRUITING

Duly Health and Care

Lisle, Illinois, 60532, United States

RECRUITING

Orchard Healthcare Research

Skokie, Illinois, 60077, United States

RECRUITING

Profound Research LLC at Michigan Hematology and Oncology Consultants

Royal Oak, Michigan, 48073, United States

RECRUITING

St. Vincent Frontier Cancer Center (SVFCC) - Billings (Frontier Cancer Center and Blood Institute)

Billings, Montana, 59102-6746, United States

RECRUITING

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

RECRUITING

Montefiore Medical Center

East Syracuse, New York, 13057, United States

RECRUITING

The Blavatnik Family, Chelsea Medical Center at Mount Sinai

Mount Sinai, New York, 10011, United States

RECRUITING

The Mark H. Zangmeister Center-Mid Ohio Oncology/Hematology, Inc.

Columbus, Ohio, 43219, United States

RECRUITING

Guthrie Medical Group

Sayre, Pennsylvania, 18840, United States

RECRUITING

Oncology Consultants PA

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Christine Fredericks

  TerSera Therapeutics LLC

  STUDY DIRECTOR

Central Study Contacts

Christine Fredericks

CONTACT

1-888-600-8116; christine.fredericks@tersera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: June 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)