A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF METMAB IN COMBINATION WITHPACLITAXEL AND BEVACIZUMAB IN PATIENTS WITH METASTATIC, TRIPLE-NEGATIVE BREAST CANCER

Phase 1

• Conditions: Metastatic, triple-negative breast cancer; MedDRA version: 12.1Level: PTClassification code 10055113Term: Breast cancer metastatic

• Registration Number: EUCTR2010-020101-32-FR
• Lead Sponsor: GENENTECH, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-15
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Women age = 18 years

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Histologically confirmed ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast, with measurable or non-measurable metastatic or locally recurrent disease

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Prior therapy with two or more regimens for metastatic breast cancer

• Any systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1

• Major surgical procedure (except CNS surgery), open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1, or anticipation of need for major surgical procedure during the course of the study

• Prior therapy with a taxane for metastatic breast cancer

• Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative

VEGF pathway-targeted therapy following diagnosis of breast cancer

• Prior therapy with hormones and/or trastuzumab

• Unstable angina

• Prior history of hypertensive crisis or hypertensive encephalopathy

• New York Heart Association Grade = II congestive heart failure

• History of myocardial infarction within 6 months prior to Day 1 of Cycle 1

• Pregnancy (positive serum pregnancy test) or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified