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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43367

Enrollment

Registered

2016-11-09

Start date

2017-02-03

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

breast carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

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

Measure	Time 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. To this end, the degree of agreement between the ex vivo anthracycline sensitivity test on BrC biopsies and the in vivo radiological response (by MRI) to anthracycline-based NAC is assessed. The radiological response by MRI is based on the percentage change in tumor size comparing baseline with size measurements after 3-4 courses of anthracycline-based chemotherapy. Good response is defined as >50% decrease intermediate response as 20% progression according to RECIST , after 3-4 courses of anthracycline containing NAC. In our ex vivo sensitivity assay (based on morphology, proliferation and apoptosis), tumors can be classified as either resistant, intermediate or highly sensitive to anthracyclines. Concordance between ex vivo and in vivo response is met when a) resistant tumors by ex vivo assay show poor response by MRI, b) highly sensitive tumors show good response, or c) intermediate sensitive tumors show intermediate response after 3-4 courses after anthracyclines-containing NAC.	—

Measure

Time 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. To this end, the degree of agreement between the ex vivo anthracycline sensitivity test on BrC biopsies and the in vivo radiological response (by MRI) to anthracycline-based NAC is assessed. The radiological response by MRI is based on the percentage change in tumor size comparing baseline with size measurements after 3-4 courses of anthracycline-based chemotherapy. Good response is defined as >50% decrease intermediate response as 20% progression according to RECIST , after 3-4 courses of anthracycline containing NAC. In our ex vivo sensitivity assay (based on morphology, proliferation and apoptosis), tumors can be classified as either resistant, intermediate or highly sensitive to anthracyclines. Concordance between ex vivo and in vivo response is met when a) resistant tumors by ex vivo assay show poor response by MRI, b) highly sensitive tumors show good response, or c) intermediate sensitive tumors show intermediate response after 3-4 courses after anthracyclines-containing NAC.

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Secondary

Measure	Time frame
1) 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. 2) Decipher the underlying molecular mechanisms of highly anthracycline sensitive/ resistant tumors. 3) Develop tumor organoids from a small part of the tumor biopsy.	—

Countries

Netherlands

Outcome results