Overview

Assessment of Safety and Efficacy of Estetrol in Postmenopausal Women With Advanced Estrogen Receptor Positive (ER+) Breast Cancer

Status:
Completed
Trial end date:
2019-12-31
Target enrollment:
0
Participant gender:
Female
Summary
This is a multi-center, open-label, phase I/IIa trial, dose-escalation study with a 3 + 3 cohort design to determine the recommended dose of estetrol for the treatment of patients with advanced breast cancer. After completing phase I part of the study (i.e. 4 weeks of treatment), patients will receive further treatment for 8 weeks at their individual phase I dose level (phase IIa part of the study).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pantarhei Oncology B.V.
Treatments:
Estrogens
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.