Study Comparing Oral AZD9833 and Intramuscular Fulvestrant for Advanced ER-positive HER2-negative Breast Cancer in Post-menopausal Women
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04214288
This clinical trial is testing the effectiveness and safety of a new oral medication, AZD9833, compared to an existing treatment, fulvestrant, for post-menopausal women with advanced ER-positive HER2-negative breast cancer.
Patient Parameters
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Program Overview
The study aims to compare how well the oral drug AZD9833 works against the standard treatment, fulvestrant, in women with advanced breast cancer that is ER-positive and HER2-negative. Participants will be randomly assigned to receive one of three different doses of AZD9833 or the standard dose of fulvestrant. The treatment will continue in 4-week cycles until the cancer progresses. After treatment ends, participants will have follow-up visits to monitor their health and survival.
Description
This study involves post-menopausal women with advanced ER-positive HER2-negative breast cancer that has either spread or returned after previous treatment. Eligible participants will be randomly assigned to one of four treatment groups: three groups will receive different doses of the oral drug AZD9833, and one group will receive the standard treatment of fulvestrant given by injection. The study will monitor the effectiveness of these treatments in controlling cancer growth and their safety for patients. Participants will have regular visits during the treatment period and follow-up visits after treatment ends to ensure their safety and track their health outcomes. As of December 2020, the study stopped enrolling participants for one of the AZD9833 doses.
Eligibility Criteria
Inclusion Criteria
- Post-menopausal women aged 18 or older.
- Have advanced ER-positive HER2-negative breast cancer that has spread or returned.
- Show evidence of cancer progression after previous treatment.
- Have at least one measurable tumor or bone lesion.
- Be in good overall health with a performance status of 0 or 1.
- Have had previous endocrine therapy and possibly chemotherapy for advanced cancer.
- Have not been treated with fulvestrant or similar therapies before.
- For a specific research subgroup, a 4-month gap from the last tamoxifen dose is required before a study biopsy.
Exclusion Criteria
- Recent treatment with certain cancer drugs or participation in another clinical study within 14 days before starting this study.
- Use of hormone replacement therapy containing estrogen within 6 months before starting the study.
- Use of certain medications or supplements that affect liver enzymes or heart rhythm.
- Heart conditions or medications that affect heart rhythm.
- Recent radiation therapy or major surgery.
- Severe or uncontrolled cancer spread to organs or the brain.
- Poor bone marrow or organ function.
- Severe digestive issues that affect medication absorption.
- Allergies to study medications.
- Previous participation in this study.
- Women who can become pregnant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 35205 | Birmingham | Alabama |
| Research Site | 90806 | Long Beach | California |
| Research Site | 33901 | Fort Myers | Florida |
| Research Site | 33705 | St. Petersburg | Florida |
| Research Site | 68506 | Lincoln | Nebraska |
| Research Site | 44710 | Canton | Ohio |
| Research Site | 37404 | Chattanooga | Tennessee |
| Research Site | 37203 | Nashville | Tennessee |
| Research Site | 54521 | Eagle River | Wisconsin |
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