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

Phase 2

Completed

• Conditions: Metastatic breast cancer; metastatic mammary cancer; 10006291

• Registration Number: NL-OMON44123
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-02-28
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 67

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

* 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Response rate (RR) (complete response (CR) and partial response (PR)) according<br /><br>to RECIST version 1.1 following 4 cycles of cDDP in the three groups of<br /><br>patients (5 or more CTCs/7.5 mL of blood and a favorable cDDP-sensitivity<br /><br>profile, *5 CTCs/7.5 ml and an unfavorable CTC cDDP-sensitivity profile and <5<br /><br>CTCs/7.5 mL of blood).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Exploratory analyses assessing the time to treatment switch (TTS), overall<br /><br>survival (OS) and cDDP toxicity in the three groups.<br /><br>- Retrospective comparison of the 96 gene CTC panel expression profiles between<br /><br>cDDP responders and non-responders following the fourth cDDP cycle (regardless<br /><br>of the patients* cDDP sensitivity profile)<br /><br>- The exploration of a possible association between a functional assay for<br /><br>predicting homologous recombination deficiency in metastatic tissue and<br /><br>clinical outcome<br /><br>- The accordance between the CTC cDDP-sensitivity profile and a metastatic<br /><br>tissue cDDP-profile.</p><br>