Prospective evaluation of the predictive value of a circulating tumor cell (CTC) sensitivity profile to Cisplatin chemotherapy in metastatic breast cancer patients

Phase 1

• Conditions: Metastatic breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005395-34-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-09
• Study Completion: 2019-09-20
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 72

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified