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Improved breast cancer therapy (I-BCT-1) in the neoadjuvant and metastatic setting: A phase 2 clinical trial protocol studying biological rationale for the optimal selection of treatment regimens.

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515087-31-00
Enrollment
260
Registered
2024-09-09
Start date
2024-09-10
Completion date
Unknown
Last updated
2025-12-17

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

Conditions

Breast cancer

Brief summary

The genomic tumor architecture as described by CAAI, and tumor cell heterogeneity before and after treatment as detected and verified by DNA analysis (SNP analysis/sequencing) and quantified by the six CARMA indices.

Detailed description

The overall change in the expression (the number and the magnitude of change) of mRNA, and protein in the different treatment groups across timepoints., Changes in the metabolite distribution (individual metabolites and magnitude) as measured by HR-MAS in the different treatment groups., Treatment induced changes and characteristics in circulating tumor DNA and circulating tumor cells in peripheral blood compared to tumor response, Difference in levels of fatigue between treatment arms., Host-related, tumor-related and treatment-related factors predicting chronic fatigue

Interventions

DRUGsolution à diluer pour perfusion

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The genomic tumor architecture as described by CAAI, and tumor cell heterogeneity before and after treatment as detected and verified by DNA analysis (SNP analysis/sequencing) and quantified by the six CARMA indices.

Secondary

MeasureTime frame
The overall change in the expression (the number and the magnitude of change) of mRNA, and protein in the different treatment groups across timepoints., Changes in the metabolite distribution (individual metabolites and magnitude) as measured by HR-MAS in the different treatment groups., Treatment induced changes and characteristics in circulating tumor DNA and circulating tumor cells in peripheral blood compared to tumor response, Difference in levels of fatigue between treatment arms., Host-related, tumor-related and treatment-related factors predicting chronic fatigue

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026