Advanced Breast Cancer study: ZOLADEX
Official title A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
ClinicalTrials.gov ID: NCT07310420
What this study is testing
What is ZOLADEX?
an investigational subcutaneous injectable medicine being studied for advanced breast cancer is designed to suppress ovarian hormone production by activating GnRH receptors and lowering luteinizing hormone levels
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
- This study is testing whether a Zoladex shot (a hormone implant) can stop the ovaries from working. It will measure hormone changes called LH.
- Who it's for
- You may be able to join if you are a premenopausal woman with early‑stage or advanced hormone‑positive breast cancer.
- What's involved
- You would get a subcutaneous Zoladex 10.8 mg implant. Doctors will check your hormone levels at the start and later visits.
- Time commitment
- The study lasts a few months with several visits to measure hormone levels.
- 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: 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%...
- Participants must be of premenopausal status.
- 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...
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.
- Selective estrogen receptor modulator (SERM) use during trial: Participants may not receive tamoxifen or other SERMs during the trial and must...
- Hypersensitivity: Known hypersensitivity, idiosyncratic, or allergic reactions to goserelin, GnRH, GnRH agonists/analogs, or any trial drug...
- Expected survival: Estimated life expectancy \<6 months from the start of trial therapy, based on the principal investigator's (PI) clinical judgment.
See the full eligibility criteria
Who can 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.
- 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.
- 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.
- 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...
- 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...
- 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...
- 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).
- 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...
- 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.
- 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).
- 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...
- Participants may have received HER2-targeted therapy (including but not limited to trastuzumab, pertuzumab, trastuzumab deruxtecan, or T-DM1).
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.
- 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...
- 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.
- 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...
- 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.
- 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.
- 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 is enrolling
- Hot Springs, Arkansas, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Ocoee, Florida, United States
- Athens, Georgia, United States
- Savannah, Georgia, United States
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Lisle, Illinois, United States
- Skokie, Illinois, United States
- Springfield, Illinois, United States
- Des Moines, Iowa, United States
- New Orleans, Louisiana, United States
- Royal Oak, Michigan, United States
- Billings, Montana, United States
- Farmington, New Mexico, United States
- Amsterdam, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Westbury, New York, United States
+ 8 more site(s).
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, but 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?
This study is enrolling now at Hot Springs, Arkansas, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Ocoee, Florida, United States; Athens, Georgia, United States; Savannah, Georgia, United States and 22 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.