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

Chugai Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: bevacizumab; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00467012

JO19901

Details and patient eligibility

About

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

Enrollment: 122 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

122 participants in 2 patient groups

step 1

Experimental group

Description:

6 enrollment for 1 cycle(4 weeks)

Treatment:

Drug: Paclitaxel

Drug: bevacizumab

step 2

Experimental group

Description:

114 enrollment through to meet the stopping criteria

Treatment:

Drug: Paclitaxel

Drug: bevacizumab