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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01094184
First Posted: March 26, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
March 16, 2010
March 26, 2010
October 12, 2017
March 2010
November 2015   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01094184 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin With Taxane Therapy in Patients With Triple Negative Breast Cancer
Open-label Study of Bevacizumab (Avastin) and Taxane Monotherapy for the First-line Treatment of Patients With Advanced Triple Negative Breast Cancer.
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: bevacizumab [Avastin]
10 mg/kg every 2 weeks, or 15 mg/kg every 3 weeks intravenously infusion according to chosen chemotherapy schedule
Experimental: 1
Intervention: Drug: bevacizumab [Avastin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
November 2015
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01094184
ML22780
2009-014279-37
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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