Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pantarhei Oncology B.V.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Postmenopausal women with ER-positive and HER2-negative locally advanced and/or metastatic breast cancer, who progressed on standard therapies or for whom standard therapies are intolerant;
Patients should have experienced a natural or surgical menopause at least 5 years ago;
Failure of anti-estrogen treatment with tamoxifen and aromatase inhibitor(s) due to the development of resistance or unacceptable side effects with this treatment;
No undiagnosed vaginal bleeding;
No treatment with fulvestrant within 6 months of start of treatment;
Life expectancy at least 6 months;
Tumour assessment (CT scan) before the start of the E4 treatment;
Body mass index (BMI) between (≥) 18 and (≤) 35 kg/m2;
Able to swallow an oral medication;
Acceptable values of hematological parameters, liver and kidney function and calcium levels;
Acceptable values of hemostasis parameters (as of second cohort);
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2 (as of second cohort);
Reasonable physical and mental health as judged by the investigator and determined by physical examination, clinical laboratory assessments and vital signs;
Willing to give informed consent in writing.
You may not be if
Uncontrolled nausea, vomiting, or diarrhea;
History of venous or arterial thromboembolic disease or a known defect in the blood coagulation system;
History of severe cardiac events or life threatening cardiac dysrhythmia (as of second cohort);
Patients who have unstable angina or clinical congestive heart failure (as of second cohort);
Uncontrolled hypertension, i.e. systolic blood pressure 160 mmHg and/or diastolic blood pressure 100 mmHg in the last 6 months with or without medication;
Diabetes mellitus with poor glycaemic control in the last 6 months (HbA1c above 7.5%);
Any other serious disease including systemic lupus erythematosus and untreated cholelithiasis;
Smoking \>10 cigarettes/day;
Use of any other cancer therapy including radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, chemotherapy, or use of other investigational agents at the start of treatment.
Clareo Health | Assessment of Safety and Efficacy of Estetrol in Postmenopausal Women With Advanced Estrogen Receptor Positive (ER+) Breast Cancer
