A clinical trial to evaluate the activity of a new targeted drug, onartuzumab, in patients with metastatic triple negative breast cancer

• Conditions: Metastatic, triple-negative breast cancer; MedDRA version: 17.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-03
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 186

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. Locally recurrent disease must not be amenable to resection with curative intent.

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 154
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

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 exposure to experimental treatment targeting either the HGF or MET pathway

• 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