Metastatic breast cancer
Conditions
Interventions
Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
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 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
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 |
|---|---|
| Main Objective: To establish whether single-agent cDDP yields a response rate considered worthwhile to be further explored in metastatic breast cancer patients with more than 5 CTCs/7.5 mL of blood harboring a favorable CTC cDDP-sensitivity profile.;Secondary Objective: • To assess significant cDDP toxicity in metastatic breast cancer patients in this setting • To explore differences in time to treatment switch (TTS) and/or overall survival (OS) between metastatic breast cancer patients with more than 5 CTCs/7.5 mL of blood harboring a favorable CTC cDDP-sensitivity profile and metastatic breast cancer patients with less than 5 CTCs/7.5mL or more than 5 CTCs/7.5mL and an unfavorable CTC cDPP-sensitivity profile • To determine differences in the 96 gene CTC panel expression profiles between cDDP responders and non-responders (regardless of the patients’ cDDP-sensitivity profile) • To explore the predictive value of a functional assay for homologous recombination deficiency assessed in tissue from metastatic lesions, for the response to cDDP therapy • To investigate the concordance between the CTC cDPP-sensitivity profile and the cDDP-sensitivity profile assessed in metastatic tissue ;Primary end point(s): The primary endpoint for this study will be the 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 <5 CTCs/7.5 mL of blood).;Timepoint(s) of evaluation of this end point: Enumeration and characterization of CTC's at baseline. Response rate following 4 cycles of cDDP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: TTS, OS and cDDP toxicity: evalation at end of study (date of last visit last subject) Metastatic tissue evaluation: at baseline;Secondary end point(s): Secondary objectives include exploratory analyses assessing the time to treatment switch (TTS), overall survival (OS) and cDDP toxicity in the three groups. Other secondary endpoints include a 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) and the exploration of a possible association between a functional assay for predicting homologous recombination deficiency in metastatic tissue and clinical outcome as well as the accordance between the CTC cDDP-sensitivity profile and a metastatic tissue cDDP-profile. | — |
Countries
Netherlands
Contacts
Public ContactTrial Office Daniel den Hoed
Erasmus MC
Outcome results
None listed