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BReast cancer Ex vivo Anthracycline Sensitivity Test (BREAST)- Using ex vivo drug sensitivity tests to optimize breast cancer therapy in the future

BReast cancer Ex vivo Anthracycline Sensitivity Test (BREAST)- Using ex vivo drug sensitivity tests to optimize breast cancer therapy in the future

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28678
Enrollment
20
Registered
2016-12-21
Start date
2016-12-12
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

None listed

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Age ≥18 years • WHO performance status 0 or 1 • Planned treatment with anthracycline-based NAC (either 3 courses of FEC or 4 courses of AC) • Written informed consent

Exclusion criteria

Exclusion criteria: • Planned treatment with TAC (taxanes concomitant with anthracyclines) courses • Current therapeutical use of anti-coagulant (coumarin derivates, warfarin, heparin or low molecular weight heparin [LMWH]) whereby a short interruption of drug use is not allowed. LMWH use in a prophylactic dose is allowed. • Any psychological condition potentially hampering compliance with the study protocol

Design outcomes

Primary

MeasureTime frame
The primary end point is the concordance between the ex vivo anthracycline sensitivity test and the in vivo response to anthracycline-based NAC on MRI.

Secondary

MeasureTime frame
Explore whether the use of different cut-off values for the ex vivo anthracycline sensitivity assay could even better predict the in vivo anthracycline response.

Contacts

Public ContactA. Jager

Erasmus MC, Room 471

a.jager@erasmusmc.nlTel 010 704 17 33

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)