Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Carrick Therapeutics Limited
With
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer.
Documented objective disease progression while on or within 6 months after the end of the most recent therapy.
Received prior AI in combination with a CDK4/6i as the last therapy
Known TP53 mutation status.
Participants must have measurable disease or bone only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks.
Expected life expectancy of \>12 weeks in the judgement of the treating investigator.
You may not be if
Inflammatory breast cancer.
Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment.
Inadequate hepatic, renal, and bone marrow function.
Clinically significant cardiovascular disease.
Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
Pregnant or breastfeeding women.
Clareo Health | A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
