Phase 3
Completed N=436
A Phase III Study of NK105 in Patients With Breast Cancer
Breast Cancer Nos Metastatic Recurrent
Source: ClinicalTrials.gov NCT01644890 ↗
Enrolled (actual)
436
Serious AEs
14.3%
Results posted
Jul 2019
Primary outcomePrimary: Progression Free Survival — 8.4; 8.5 months
◆ Published Evidence
Highly cited
130citations · ~19 / year
A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients.
Summary
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.
Linked Publications
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A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
8.4; 8.5 | — |
| SECONDARY Overall Survival |
31.2; 36.2 | — |
| SECONDARY Overall Response Rate |
31.6; 39.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01644890) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.