Metastasis of breast cancer
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Female metastatic breast cancer patients with ER-positive, HER2- negative primary tumors; 2. Previous treatment with at least an aromatase inhibitor either in adjuvant and/or metastatic setting; 3. Failure to previous treatment with at least one type of aromatase inhibitor (non-steroidal/steroidal) for MBC; 4. Considered fit enough to receive taxane-based chemotherapy by the treating physician; either as a first line chemotherapy for metastatic breast cancer or as second line treatment if the time between completion of first line chemotherapy for metastatic breast cancer and inclusion is more than three years. 5. Intention to start with either paclitaxel and docetaxel; 6. Patient with measurable or clinically evaluable (bone only) disease on recent standard work-up for MBC; 7. CT chest and abdomen must not be older than 42 days on the day of the anticipated treatment start; 8. Age >=18 years old; 9. WHO performance status 0-2; 10. Signed written informed consent;
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy for metastatic disease, completed within three years before inclusion; 2. Patients with locally advanced disease, primary not amendable for resection or radiation therapy with curative intent; 3. (neo)adjuvant chemotherapy within 6 months prior to treatment start; 4. Anti-hormonal treatment for breast cancer within two weeks prior to treatment start; 5. Symptomatic CNS metastasis (the presence of at least one key symptom in combination with radiologic evidence (positive contrast-enhanced CT or MRI of the brain)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this study will be the progression free survival rate at 6 months (PFS6mnths) in ESR1 mutated MBC patients treated with taxane-based chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome to taxane-based chemotherapy in ESR1 mutated and wild-type patients measured as progression free-rate at 6 months, progression free survival and overall survival. The relation between serial measurement of ESR1 mutations and clinical follow-up data (i.e. survival and efficacy). The relation between different activating ESR1 mutations (e.g. D538G and Y537S) and treatment outcome measured as progression free- and overall survival. The assessment of baseline and progression ESR1 mutational status, in order to learn whether ESR1 mutations can be lost during treatment. | — |
Countries
Netherlands
Outcome results
None listed