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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01094184
First received: March 16, 2010
Last updated: July 7, 2014
Last verified: July 2014

March 16, 2010
July 7, 2014
March 2010
October 2014   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 e ffect 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) brea st cancer. Patients are eligible to participate in this study if they have not r eceived 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 bevacizum ab (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 i s < 100 patients.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
49
October 2014
October 2014   (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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01094184
ML22780, 2009-014279-37
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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