NL-OMON44123
Completed
Phase 2
Prospective evaluation of the predictive value of a circulating tumor cell (CTC) sensitivity profile to Cisplatin chemotherapy in metastatic breast cancer patients - CTC-cDDP
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Metastatic breast cancer
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 67
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Female patient with metastatic breast cancer who has been pretreated with at least anthracycline and taxane\-based chemotherapy in the adjuvant and/or metastatic setting ;\* Measurable disease according to RECIST 1\.1, ie at least one measurable lesion on CT\-scan where the longest diameter in the plane of measurement is a minimum size of 10mm;\* Age \* 18 years;\* WHO performance status \*2;\* Adequate hematological functions defined as ANC \* 1\.0 x 109/L, platelets \* 100 x 109/L;\* Adequate renal function defined as creatinin clearance \* 60 mL/min (Cockcroft Gault);\* Patients with reproductive potential must use a reliable method of contraception;\* Written informed consent
Exclusion Criteria
- •\* Other anticancer chemotherapy, use of biological response modifiers, or immunotherapy within two weeks prior to treatment start. Hormonal antitumor treatment within one week prior to treatment start. ;\* Hearing loss of at least Common Terminology Criteria for Adverse Events (CTCAE) grade 2;\* Neuropathy of at least CTCAE grade 2;\* Pregnant or lactating patients;\* Serious illness or medical unstable condition prohibiting adequate treatment and follow\-up ;\* Symptomatic CNS metastases (the presence of at least one key symptom in combination with radiologic evidence (positive contrast\-enhanced CT or MRI of the brain));\* History of psychiatric disorder that would prohibit the understanding and giving of informed consent or that would prohibit adequate follow\-up
Outcomes
Primary Outcomes
Not specified
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