Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

Chugai Pharmaceutical122 enrolled

Overview

To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Metastatic Breast Cancer

Interventions

bevacizumabDRUG

10mg/kg，Day1, 15 of 1 cycle(4 weeks)

PaclitaxelDRUG

90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

* At least 20 years old and obtained a written informed consent * Advanced breast cancer (StageⅣ) or Inoperable metastatic breast cancer * HER2 negative * At least one measurable lesion based on RECIST criteria * No previous chemotherapy for metastatic breast cancer

Locations (5)

Kanto Region

Kanto, Japan

Kinki Region

Kinki, Japan

Kyushu region

Kyushu, Japan

Sikoku region

Sikoku, Japan

Tohoku region

Tōhoku, Japan

Outcomes

Primary Outcomes

Safety

Time frame: throughout study

Progression-free survival (PFS)

Time frame: event driven

Secondary Outcomes

Overall Survival(OS)

Time frame: event driven

Time to Treatment Failure(TTF)

Time frame: evnt driven

Response Rate(RR)

Time frame: event driven

Data from ClinicalTrials.gov

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