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New treatment option for Advanced Breast Cancer
Official title A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer
ClinicalTrials.gov ID: NCT07310420
What this study is testing
What is ZOLADEX?
ZOLADEX is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for advanced breast cancer.
Also referred to as Goserelin implant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, women only
You may be able to join 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...
- Advanced or metastatic breast cancer: Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is...
- HR+: Either estrogen receptor positive (ER+) or progesterone receptor positive (PR+) breast cancer, defined as 1% to 100% of tumor nuclei are...
You likely can't join if
- Postmenopausal: Naturally or surgically postmenopausal (regardless of age).
- Body mass index (BMI): \ 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- Concurrent Medications:
- 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.
- PIK3CA/AKT inhibitors are permitted if started at least 2 weeks before the trial and tolerated without ongoing toxicity CTCAE v6.0 \>Grade 1.
- 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.
- Concomitant use of endocrine therapy (eg, aromatase inhibitor, fulvestrant, or other FDA-approved selective estrogen receptor degraders [SERDs]) is permitted.
- Informed consent: Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.
- Contraceptive use: Female participants may be enrolled if they are:
- 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...
- 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...
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
What rules you out
- Postmenopausal: Naturally or surgically postmenopausal (regardless of age).
- Body mass index (BMI): \ 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...
- 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...
- 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.
- 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...
- 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...
- Cardiac conditions:
- Corrected QT interval (QTc) using Fridericia's correction (QTcF) \>450 ms at Screening.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hot Springs, Arkansas, United States
- Washington D.C., District of Columbia, United States
- Ocoee, Florida, United States
- Savannah, Georgia, United States
- Evanston, Illinois, United States
- Lisle, Illinois, United States
- Skokie, Illinois, United States
- Royal Oak, Michigan, United States
- Billings, Montana, United States
- Farmington, New Mexico, United States
- East Syracuse, New York, United States
- Mount Sinai, New York, United States
- Columbus, Ohio, United States
- Sayre, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hot Springs, Arkansas, United States; Washington D.C., District of Columbia, United States; Ocoee, Florida, United States; Savannah, Georgia, United States; Evanston, Illinois, United States; Lisle, Illinois, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.