A single arm multicenter biomarker study determining the response to taxane-based chemotherapy in metastatic breast cancer (MBC) patients with ESR1 mutations in cell-free DNA: TAX-ESR1 study. - TAX-ESR1 study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 175 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•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;

•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)

发起方