Clinical trial · Interventional
A Phase III Study of NK105 in Patients With Breast Cancer
A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
NCT01644890CI-TRIAL-00039771completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Nos Metastatic Recurrent | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NK105 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NK105
- interventionNames
- Drug: NK105
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Baseline, every 6 weeks of study treatment period, and end of study,
- description
- PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1. Assessment period was from the day of randomisation until the first observation of lesion progression or death
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent of the patient signed by herself. * Histologically confirmed metastatic or recurrent adenocarcinoma of the breast. * Aged 20 to 74 at the time of informed consent. Exclusion Criteria: * Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.
References
Publications (1)
- DERIVEDFujiwara Y, Mukai H, Saeki T, Ro J, Lin YC, Nagai SE, Lee KS, Watanabe J, Ohtani S, Kim SB, Kuroi K, Tsugawa K, Tokuda Y, Iwata H, Park YH, Yang Y, Nambu Y. A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients. Br J Cancer. 2019 Mar;120(5):475-480. doi: 10.1038/s41416-019-0391-z. Epub 2019 Feb 12. PMID 30745582