Actively Recruiting
Phase 1 Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer
Led by TerSera Therapeutics LLC · Updated on 2026-06-03
88
Participants Needed
11
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ovarian suppression in premenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. This phase 1 trial aims to measure how effectively ZOLADEX 10.8 mg suppresses ovarian function by tracking luteinizing hormone (LH) levels during treatment. The study focuses on women aged 18 to 55 who have either not received gonadotropin-releasing hormone (GnRH) treatment or have been exposed to it for less than six months. Participants will receive two subcutaneous injections of ZOLADEX 10.8 mg: one on Day 1 (Week 1) and another on Day 85 (Week 12). The study monitors ovarian suppression by measuring LH and estradiol levels and recording the absence of menstruation over 24 weeks. This open-label, multicenter trial does not involve a placebo or comparator group. During the study, participants will undergo regular blood tests to measure hormone levels at Weeks 6, 12, 18, and 24. Researchers will assess ovarian suppression consistency and safety by evaluating hormone thresholds and menstrual status. The total participation duration covers at least 24 weeks, with ongoing monitoring for treatment effects and adverse events throughout the trial period.
CONDITIONS
Brief Title
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 55 years, either GnRH treatment-na�EFve or exposed to GnRH treatment for less than 6 months
- Histological confirmation of advanced or metastatic breast cancer not suitable for surgery or radiation with curative intent
- Hormone receptor positive breast cancer (ER+ or PR+ with 1% to 100% tumor nuclei positive)
- HER2-negative breast cancer as defined by ASCO-CAP guidelines
- May have received prior radiotherapy and/or certain stable medications (CDK4/6 inhibitors, PIK3CA-AKT inhibitors, bisphosphonates)
- GnRH treatment-na�EFve participants must have no prior GnRH agonist or endocrine therapy in advanced/metastatic setting
- May have received adjuvant or neoadjuvant chemotherapy with recovery from toxicities to specified levels
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Able to understand, willing to provide informed consent, and comply with study procedures
- Use of effective nonhormonal contraception or true abstinence with negative pregnancy tests before and during the trial
You will not qualify if you...
- Postmenopausal status, naturally or surgically
- Body mass index (BMI) less than 18 kg/m2 or greater than 35 kg/m2
- History of bilateral oophorectomy or prior radiotherapy to the ovaries
- Recent radiotherapy for breast cancer within 4 weeks or planned during the trial
- Use of selective estrogen receptor modulators (SERMs) like tamoxifen during the trial
- Known allergies to goserelin, GnRH, or trial drug components
- Estimated life expectancy less than 6 months
- ECOG performance status of 3 or higher
- Life-threatening metastatic visceral disease with symptomatic involvement
- Abnormal liver or kidney function beyond specified limits
- Severe hematologic abnormalities
- Active malignancy within past 3 years except certain skin or cervical cancers
- Severe or uncontrolled medical or psychiatric conditions
- Recent use of investigational drugs or devices
- Positive pregnancy or breastfeeding
- Sexually active without use of nonhormonal contraception unless specific exceptions apply
- Significant cardiac conditions including prolonged QT interval or recent heart events
- Severe allergies or history of anaphylaxis
- Recent major surgery within 30 days
- Any condition that may interfere with study compliance or safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 weeks
Participants receive ZOLADEX as a subcutaneous injection on Day 1 (Week 1) and Day 85 (Week 12) to evaluate ovarian suppression.
Visits at Weeks 1, 6, 12, 18, and 24
Trial Site Locations
Total: 11 locations
1
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
2
MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Cancer Centers of Florida
Ocoee, Florida, United States, 34761
Actively Recruiting
4
Summit Cancer Care
Savannah, Georgia, United States, 31405
Actively Recruiting
5
Duly Health and Care
Lisle, Illinois, United States, 60532
Actively Recruiting
6
Orchard Healthcare Research
Skokie, Illinois, United States, 60077
Actively Recruiting
7
Profound Research LLC at Michigan Hematology and Oncology Consultants
Royal Oak, Michigan, United States, 48073
Actively Recruiting
8
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
Actively Recruiting
9
The Mark H. Zangmeister Center-Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States, 43219
Actively Recruiting
10
Guthrie Medical Group
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
11
Oncology Consultants PA
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Christine Fredericks
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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