Advanced Breast CancerPhase 1NCT07310420
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
A Phase 1 study testing ZOLADEX in people with Advanced Breast Cancer and Early Breast Cancer, run by TerSera Therapeutics LLC at 26 sites in United States.
Trial summary
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH) within each cohort. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Advanced Breast Cancer, Early Breast Cancer
- What is being tested?
- ZOLADEX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 26 sitesUnited States
- Study dates
- 30 Oct 2026to 31 Jul 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age and gender: Female participants aged 18 to 55 years, inclusive.
- Hormone receptor positive (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.
- Participants must be of premenopausal status.
- Recent radiotherapy:
- Prior radiotherapy is allowed.
- All radiotherapy-related toxicities (except alopecia) must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 Grade ≤1 before trial enrollment.
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- Concurrent medications:
- Cyclin-dependent kinase 4 (CDK4/6) inhibitors are permitted.
- PIK3CA/AKT inhibitors are permitted.
- Concomitant use of bisphosphonates is permitted.
- Concomitant use of endocrine therapy (eg, aromatase inhibitor, fulvestrant, or other FDA-approved selective estrogen receptor degrader [SERDs]) is permitted.
- Concurrent standard-of-care human epidermal growth factor receptor 2 (HER2)- targeted therapy (including but not limited to trastuzumab, pertuzumab, trastuzumab deruxtecan, or T-DM1) is permitted.
- Informed consent: Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.
- Abstinence and contraception: Female participants may be enrolled if they are:
- Practicing true abstinence for at least 28 days prior to investigational product (IP) administration until 12 weeks after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, OR
- 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 12 weeks after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1.
- Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Inclusion Criteria specific to the advanced breast cancer cohort:
- Advanced breast cancer diagnosis: 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.
- Chemotherapy History:
- A participant may have received chemotherapy provided the criteria for premenopausal status, as defined in Inclusion Criterion #3, are met at trial screening.
- All chemotherapy-related toxicities must have recovered to CTCAE v6.0 ≤Grade 1 before trial participation, except for alopecia, peripheral neuropathy, or paresthesia (≤Grade 2).
- Prior treatment:
- Participants may have received prior radiotherapy.
- Participants may have received or be receiving a cyclin-dependent kinase (CDK) 4/6 inhibitor, a PIK3CA-AKT inhibitor, or bisphosphonates.
- Gonadotropin-releasing hormone (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 in the advanced/metastatic setting, provided they had established premenopausal status (Inclusion Criterion #3) prior to initiating GnRH agonist therapy, within 6 months prior to trial enrollment.
- Participants may have received HER2-targeted therapy (including but not limited to trastuzumab, pertuzumab, trastuzumab deruxtecan, or T-DM1).
- Inclusion Criteria specific to the early-stage breast cancer cohort:
- Early-stage breast cancer diagnosis:
- Histologically confirmed unilateral or bilateral invasive adenocarcinoma of the breast.
- Pathologically staged as Stage I, II, or III (specifically T1-T4, N0-N3, M0) at the time of definitive surgery, according to the current American Joint Committee on Cancer (AJCC) Staging Manual.
- Chemotherapy history:
- A participant may have received adjuvant or neoadjuvant chemotherapy provided the criteria for premenopausal status, as defined in Inclusion Criterion #3, are met at trial Screening.
- All chemotherapy-related toxicities must have recovered to CTCAE v6.0 ≤Grade 1 before trial participation except for alopecia, peripheral neuropathy, or paresthesia (≤Grade 2).
- Prior treatment:
- Participants may have received prior radiotherapy.
- Participants may have received or be receiving a CDK 4/6 inhibitor, a PIK3CA-AKT inhibitor, or bisphosphonates.
- GnRH treatment-naïve participants will have no history of GnRH agonist or other endocrine therapy.
- GnRH treatment-exposed participants may have received a GnRH agonist or other endocrine therapy provided they had established premenopausal status (Inclusion Criterion #6) prior to initiating GnRH agonist therapy, within 6 months prior to trial enrollment.
- Participants may have received HER2-targeted therapy (including but not limited to trastuzumab, pertuzumab, trastuzumab deruxtecan, or T-DM1).
Who cannot join
- 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.
- 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.
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- 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).
- Renal function: Creatinine clearance (CrCl) ≤30 mL/min as calculated by the Cockcroft-Gault formula.
- Hematologic parameters:
- Hemoglobin (Hgb) <8.0 g/dL.
- White blood cell (WBC) count <3000/mm^3.
- Platelets <100,000/mm^3.
- Eligibility for participants taking CDK4/6 inhibitors should be based on D-1 labs.
- An absolute neutrophil count (ANC) <1500/mm3 on D-1 is exclusionary.
- Other malignancies: Active malignancy within the past 3 years, except for adequately treated basal or squamous cell skin cancer or in situ cervical carcinoma.
- 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.
- Investigational drug exposure: Exposure to any investigational drug or device within 30 days prior to trial enrollment.
- Pregnancy: Participant has childbearing potential with a positive serum pregnancy test or positive urine pregnancy test at Screening or Day 1.
- Breastfeeding: Participant is currently breastfeeding.
- 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.
- Cardiac conditions:
- Corrected QT interval (QTc) using Fridericia's correction (QTcF) >450 ms at Screening.
- Uncontrolled or symptomatic heart disease, including:
- New York Heart Association (NYHA) Class III or IV heart failure.
- Myocardial infarction within the past 6 months.
- Unstable angina or significant arrhythmias requiring intervention.
- Documented congenital QT syndrome.
- 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.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within the last 1 year prior to IP administration.
- Major surgery within 30 days prior to IP dosing or a major surgical procedure planned during the trial.
- 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.
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
United States26 sites, 26 recruiting
- Recruiting
New York Oncology Hematology - Amsterdam Cancer Center
Amsterdam, New York, 12010
Ami Negandhi, MD
- Recruiting
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Addie Hill, MD
- Recruiting
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Maria Hafez, MD
- Recruiting
St. Vincent Frontier Cancer Center (SVFCC) - Billings (Frontier Cancer Center and Blood Institute)
Billings, Montana, 59102-6746
Patrick Cobb, MD
- Recruiting
WakeMed Cancer Care - Waverly Hematology & Medical Oncology
Cary, North Carolina, 27518
Pallavi Kopparthy, MD
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Vijayakrishna Gadi, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Shimoli Barot, MD
- Recruiting
The Mark H. Zangmeister Center-Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43219
Jeanna Knoble, MD
- Recruiting
Mission Cancer and Blood
Des Moines, Iowa, 50309
Seema Harichand-Herdt, MD
- Recruiting
NorthShore University Health System - Evanston Hospital
Evanston, Illinois, 60201
Poornima Saha, MD
- Recruiting
San Juan Oncology Associates
Farmington, New Mexico, 87401
Jeffrey Neidhart, MD
- Recruiting
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, 71913
Stephen Divers, MD
- Recruiting
Oncology Consultants PA
Houston, Texas, 77030
Ricardo Alvarez, MD
- Recruiting
Duly Health and Care
Lisle, Illinois, 60532
Daniel Frank, MD
- Recruiting
Ochsner Medical Center (OMC)
New Orleans, Louisiana, 70121
Melanie Sheen, MD
- Recruiting
Chelsea Medical Center at Mount Sinai
New York, New York, 10011
Paula Klein, MD
- Recruiting
Cancer Centers of Florida
Ocoee, Florida, 34761
Gopal Kunta, MD
- Recruiting
Profound Research LLC at Michigan Hematology and Oncology Consultants
Royal Oak, Michigan, 48073
Savitha Balaraman, MD
- Recruiting
Summit Cancer Care
Savannah, Georgia, 31405
Mark Taylor, MD
- Recruiting
Guthrie Medical Group
Sayre, Pennsylvania, 18840
Joyson Poulose, MD
- Recruiting
Orchard Healthcare Research
Skokie, Illinois, 60077
Ira Oliff, MD
- Recruiting
Cancer Care Northwest
Spokane, Washington, 99202
Saritha Thumma, MD
- Recruiting
Springfield Clinic - The Cancer Center
Springfield, Illinois, 62702
Namita Vinayek, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Jinyu Lu, MD
- Recruiting
MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Ami Chitalia, MD
- Recruiting
Clinical Research Alliance Inc
Westbury, New York, 11590
Jonathan Goldberg, MD
About this study
Official title: Phase 1 Single-arm, Open-label, Multicenter Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in 2 Parallel Cohorts of Premenopausal Women With Early-stage and Advanced Hormone Receptor-positive (HR+) Breast Cancer
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH) within each cohort.
Read the 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.
- Conditions
- Advanced Breast Cancer, Early Breast Cancer
- Being tested
- ZOLADEX
- Keywords
- Ovarian Suppression, ZOLADEX, HR+, Breast Cancer, Goserelin Implant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOLADEXDrug
Also called Goserelin implant
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.
| Study group | Role | What they receive |
|---|---|---|
| ZOLADEX 10.8 mg | Experimental | Participants will receive 10.8 mg ZOLADEX on Day 1 and Day 85. Receives: Drug: ZOLADEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with LH Values Below a Specified Threshold at Week 6 Within Each Cohort
Measured: Week 6
Secondary outcomes (3)
Percentage of Participants with LH Values below a Specified Threshold at Weeks 12, 18, and 24 Within Each Cohort
Measured: Weeks 12, 18, and 24
Percentage of Participants with Estradiol (E2) Suppression at Weeks 6, 12, 18, and 24 Within Each Cohort
Measured: Weeks 6, 12, 18, and 24
Percentage of Participants with Absence of Menses at Weeks 6, 12, 18, and 24 Within Each Cohort
Measured: Weeks 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start30 Oct 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TerSera Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Fredericks, Study director, TerSera Therapeutics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310420
- Sponsor's protocol ID
- TER-ZLDX-0101
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No