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A translational RANDOMIZED phase III study exploring the effect of the addition of capecitabine to Carboplatinum based chemotherapy in early “triple negative” breast cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501102-35-00
Acronym
NordicTrip
Enrollment
325
Registered
2024-06-05
Start date
2019-12-02
Completion date
Unknown
Last updated
2025-07-08

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

Conditions

Early triple negative breast cancer

Brief summary

pCR with the addition of capecitabine compared with carboplatin-based chemotherapy alone.

Detailed description

Invasive Disease Survival (IDFS) with the addition of capecitabine compared with carboplatin-based chemotherapy alone., Breast Cancer Specific Survival (BCSS) with the addition of capecitabine compared with carboplatin-based chemotherapy alone., Overall Survival (OS) with the addition of capecitabine compared with carboplatin-based chemotherapy alone.

Interventions

DRUGCAPECITABINE
DRUGPACLITAXEL
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGEPIRUBICIN
DRUGCYCLOPHOSPHAMIDE
DRUGCARBOPLATIN

Sponsors

Region Skåne
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
pCR with the addition of capecitabine compared with carboplatin-based chemotherapy alone.

Secondary

MeasureTime frame
Invasive Disease Survival (IDFS) with the addition of capecitabine compared with carboplatin-based chemotherapy alone., Breast Cancer Specific Survival (BCSS) with the addition of capecitabine compared with carboplatin-based chemotherapy alone., Overall Survival (OS) with the addition of capecitabine compared with carboplatin-based chemotherapy alone.

Countries

Denmark, Sweden

Outcome results

None listed

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