Phase IIIb Study of Camizestrant and Ribociclib for Advanced ER-positive, HER2-negative Breast Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07647328
This study is testing the combination of camizestrant and ribociclib to see if it is effective and safe for patients with advanced ER-positive, HER2-negative breast cancer who have not received prior treatment for advanced disease.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to evaluate how well the combination of camizestrant and ribociclib works in treating advanced ER-positive, HER2-negative breast cancer. It will also assess the safety and tolerability of this treatment in patients who have not previously received systemic therapy for their advanced cancer. Participants will continue with the study treatment until they choose to stop or need to discontinue for any reason.
Description
This is a global study involving multiple centers, focusing on patients with advanced ER-positive, HER2-negative breast cancer. The study will include about 150 participants who will receive daily oral doses of camizestrant (75 mg) and ribociclib (600 mg). The goal is to determine the effectiveness and safety of this combination treatment. Participants will remain in the study until they decide to stop or need to discontinue the treatment for any reason.
Eligibility Criteria
Inclusion Criteria
- Able to provide informed consent.
- Age 18 or older.
- Diagnosed with ER-positive, HER2-negative breast cancer that cannot be treated with surgery or radiation.
- Have not received any prior systemic treatment for advanced breast cancer.
- Have Stage 4 breast cancer or a recurrence after early-stage treatment, with at least 12 months since the last dose of adjuvant therapy without disease progression.
- ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Adequate organ and bone marrow function.
- Women and men who are sexually active must use effective contraception during the study and for a period after treatment ends.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and use effective contraception.
- Men must use condoms and spermicide if their partner is of childbearing potential, and must not donate sperm during the study.
Exclusion Criteria
- Not suitable for endocrine therapy with ribociclib.
- No evidence of advanced inoperable disease or bone-only disease with specific bone lesions.
- Have advanced cancer with symptoms that could lead to life-threatening complications soon.
- Have ongoing severe side effects from previous treatments.
- Have active infections like tuberculosis, hepatitis B or C.
- Have tested positive for HIV, unless meeting specific guidelines.
- Have significant heart rhythm problems, unless controlled with a pacemaker or medication.
- Have ongoing low blood pressure symptoms.
- Are pregnant or breastfeeding, or not willing to use effective contraception.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 91010 | Duarte | California |
| Research Site | 94304 | Palo Alto | California |
| Research Site | 30060 | Marietta | Georgia |
| Research Site | 60201 | Evanston | Illinois |
| Research Site | 41017 | Edgewood | Kentucky |
| Research Site | 40202 | Louisville | Kentucky |
| Research Site | 89502 | Reno | Nevada |
| Research Site | 57105 | Sioux Falls | South Dakota |
| Research Site | 37204 | Nashville | Tennessee |
| Research Site | 76104 | Fort Worth | Texas |
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