EUCTR2012-005395-34-NL
Active, not recruiting
Phase 1
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 1
- Intervention
- Not specified
- Conditions
- Metastatic breast cancer
- Sponsor
- Erasmus MC
- Enrollment
- 72
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
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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