Study on the Safety and Tolerability of Camizestrant and Atirmociclib in Women with Advanced Breast Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07427394
This clinical trial is exploring the safety and tolerability of combining two drugs, camizestrant and atirmociclib, in women with advanced breast cancer that is estrogen receptor-positive and HER2-negative, and who have previously been treated with a CDK4/6 inhibitor.
Patient Parameters
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Program Overview
The study aims to evaluate how safe and tolerable the combination of camizestrant and atirmociclib is for women with advanced breast cancer that is estrogen receptor-positive and HER2-negative. Participants in this study have already received treatment with a CDK4/6 inhibitor. The study will include several phases: a screening period, a single dose period of atirmociclib, a period where both drugs are given together, and a follow-up period after treatment.
Description
This Phase IIa study is designed to assess the safety, tolerability, and initial effectiveness of the drug combination camizestrant and atirmociclib in women with advanced breast cancer. The study is open-label, meaning both the researchers and participants know which treatment is being administered. It involves several stages:
- Screening Period: Initial assessments to determine eligibility.
- Atirmociclib Single Dose Period: Participants receive a single dose of atirmociclib.
- Doublet Intervention Period: Participants receive both camizestrant and atirmociclib.
- Post-Treatment Follow-Up Period: Monitoring participants' health after treatment ends.
Eligibility Criteria
Inclusion Criteria
- Women with advanced breast cancer that has spread or returned after previous treatment.
- Must have shown progression of the disease after the last treatment.
- Good overall health with a performance status score of 0 or 1, and expected to live at least 12 more weeks.
- At least one tumor that can be measured and tracked using scans or exams.
- Must be menopausal or meet specific criteria if pre-menopausal, such as starting hormone therapy before the study.
- Must have a confirmed diagnosis of breast adenocarcinoma.
- Women who can become pregnant must use effective birth control.
- Tumor must be estrogen receptor-positive.
Exclusion Criteria
- Have received two or more treatments with CDK4/6 inhibitors for advanced cancer.
- Have previously been treated with camizestrant or atirmociclib for advanced cancer.
- Have been treated with other experimental estrogen receptor degraders or CDK inhibitors for advanced cancer.
- Cannot swallow pills.
- Have unresolved side effects from previous cancer treatments, except hair loss.
- Have life-threatening cancer spread to organs.
- Have severe or uncontrolled diseases.
- Have allergies or intolerances to camizestrant or atirmociclib.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 63108 | St Louis | Missouri |
| Research Site | 02915 | East Providence | Rhode Island |
| Research Site | 37203 | Nashville | Tennessee |
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