A Phase III Study of NK105 in Patients With Breast Cancer

Nippon Kayaku

Status and phase: Completed; Phase 3

Conditions: Breast Cancer Nos Metastatic Recurrent

Treatments: Drug: Paclitaxel; Drug: NK105

Study type: Interventional

Funder types: Industry

Identifiers

NCT01644890

A3105301

Details and patient eligibility

About

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.

Full description

This study is a randomized, open-label, multi-national phase III study.

Enrollment: 436 patients

Sex: Female

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 2 patient groups

NK105

Experimental group

Treatment:

Drug: NK105

Paclitaxel

Active Comparator group

Treatment:

Drug: Paclitaxel