Metastatic breast cancer metastatic mammary cancer
Conditions
Interventions
Three interventions are considered as study-specific:
1) the blood collection for CTC enumeration and characterization
2) the administration of cDDP (though cDDP is also frequently given to this
pat
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RR) (complete response (CR) and partial response (PR)) according to RECIST version 1.1 following 4 cycles of cDDP in the three groups of patients (5 or more CTCs/7.5 mL of blood and a favorable cDDP-sensitivity profile, *5 CTCs/7.5 ml and an unfavorable CTC cDDP-sensitivity profile and | — |
Secondary
| Measure | Time frame |
|---|---|
| - Exploratory analyses assessing the time to treatment switch (TTS), overall survival (OS) and cDDP toxicity in the three groups. - Retrospective comparison of the 96 gene CTC panel expression profiles between cDDP responders and non-responders following the fourth cDDP cycle (regardless of the patients* cDDP sensitivity profile) - The exploration of a possible association between a functional assay for predicting homologous recombination deficiency in metastatic tissue and clinical outcome - The accordance between the CTC cDDP-sensitivity profile and a metastatic tissue cDDP-profile. | — |
Countries
Netherlands
Outcome results
None listed