CTC sensitivity profile to Cisplatin chemotherapy
- Conditions
- Gemetastaseerd mammacarcinoom, metastatic breast cancer, cisplatin, cDDP, circulerende tumorcellen, circulating tumor cells, moleculaire karakterisatie, molecular characterization
- Registration Number
- NL-OMON24910
- Lead Sponsor
- Erasmus MC Cancer Center, Department of Medical Oncology
- Brief Summary
de Kruijff et al. Prospective Evaluation of a Circulating Tumor Cell Sensitivity Profile to Predict Response to Cisplatin Chemotherapy in Metastatic Breast Cancer Patients. Frontiers in Oncology (2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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, i.e. at least one measurable lesion on CT-scan where the longest diameter in the plane of measurement is a minimum size of 10mm
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate (RR) (complete response (CR) and partial response (PR)) according to RECIST version 1.1 following 4 cycles of cDDP in 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).
- Secondary Outcome Measures
Name Time Method - Time to treatment switch<br /><br>- Overall survival<br /><br>- cDDP toxicity <br /><br>- Retrospective comparison of CTC expression profiles between cDDP responders and non-responders (regardless of the patients¡¯ cDDP sensitivity profile) <br /><br>- Association between a functional assay for predicting homologous recombination deficiency in metastatic tissue and clinical outcome <br /><br>- Accordance between the CTC cDDP-sensitivity profile and a metastatic tissue cDDP-profile.