A Study of Avastin With Taxane Therapy in Patients With Triple Negative Breast Cancer

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01094184

First received: March 16, 2010

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 16, 2010

Last Updated Date

May 7, 2013

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety, Tolerability: AEs, quality of life questionnaires [ Time Frame: AEs: Throughout study until 6 months after final dose of bevacizumab; quality of life questionnaires: every 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01094184 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy: time to disease progression, duration of survival, change in Karnofsky performance status [ Time Frame: At the completion of cycles 1, 2, 3, 4 and subsequent cycles ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Avastin With Taxane Therapy in Patients With Triple Negative Breast Cancer

Official Title ^ICMJE

Open-label Study of Bevacizumab (Avastin) and Taxane Monotherapy for the First-line Treatment of Patients With Advanced Triple Negative Breast Cancer.

Brief Summary

This open-label, multi-centre study will evaluate the safety, tolerability and effect on disease progression, survival time and Karnofsky performance status of bevacizumab (Avastin) in combination with taxane monotherapy in female patients with oestrogen-, progesterone- and HER2-receptor negative (triple-negative) breast cancer. Patients are eligible to participate in this study if they have not received prior chemotherapy for metastatic breast cancer and in the investigator's opinion, require combination therapy for treatment of their disease. Patients will receive taxane (weekly paclitaxel or three-weekly docetaxel) and bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks as intravenously infusion). The treatment will continue until disease progression. The target sample size is < 100 patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: bevacizumab [Avastin]

10 mg/kg every 2 weeks, or 15 mg/kg every 3 weeks intravenously infusion according to chosen chemotherapy schedule

Study Arm (s)

Experimental: 1

Intervention: Drug: bevacizumab [Avastin]

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients >/=18 years of age
Histologically confirmed triple-negative (oestrogen and progesterone receptor (ER/PgR) and HER2 receptor negative) adenocarcinoma of the breast with metastatic disease
Patient who in the Investigator's opinion requires combination therapy for their disease
Life expectancy >/=12 weeks

Exclusion Criteria:

Previous chemotherapy for metastatic breast cancer (adjuvant chemotherapy is allowed)
Patients currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)
Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: ML22780 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01094184

Other Study ID Numbers ^ICMJE

ML22780, 2009-014279-37

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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