A Study of Avastin (Bevacizumab) in Combination With Gemcitabine and Carboplatin as First Line Treatment in Patients With Triple Negative Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01201265
First received: September 6, 2010
Last updated: July 7, 2014
Last verified: July 2014

September 6, 2010
July 7, 2014
February 2011
May 2015   (final data collection date for primary outcome measure)
Progression-free survival (PFS), according to RECIST criteria, assessments by CT/MRI/bone scans and X-ray [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01201265 on ClinicalTrials.gov Archive Site
  • Overall Response Rate (ORR), according to RECIST criteria, assessed by CT/MRI/bone scan and Xray [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Clinical benefit response (CBR) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Time to Progression (TTP) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety and tolerability: Adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Quality of Life: European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Hemodynamic measurements: brachial blood pressure, heart rate [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Gemcitabine and Carboplatin as First Line Treatment in Patients With Triple Negative Metastatic Breast Cancer
Multi Centre, Pilot Phase II Trial Assessing the Efficacy and Safety of Bevacizumab + Gemcitabine + Carboplatin as First Line Treatment for Patients Diagnosed With Triple Negative Metastatic Breast Cancer.

This multicenter study will assess the efficacy and safety of Avastin (bevacizum ab) in combination with gemcitabine and cisplatin as first line treatment in pat ients with triple negative metastatic breast cancer. Patients will receive Avast in at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (100 0 mg/m2 iv) and carboplatin (iv to an AUC=2) on Days 1 and 8 of each 3-week cyc le. Anticipated time on study treatment is until disease progression.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: bevacizumab [Avastin]
    15 mg/kg iv every 3 weeks
  • Drug: gemcitabine
    1000 mg/m2 iv on days 1 and 8 of each 3-week cycle
  • Drug: carboplatin
    to an AUC = 2, on days 1 and 8 of each 3-week cycle
Experimental: Single Arm
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: gemcitabine
  • Drug: carboplatin
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
40
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female patients, >/= 18 years of age
  • Metastatic breast cancer
  • Estrogen receptor- , progesterone- and HER2-negative disease
  • Treatment-naïve for metastatic breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Prior first line treatment for metastatic breast cancer
  • CNS metastasis
  • Uncontrolled hypertension (> 170/95 mmHg)
  • Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
  • History of other malignant disease within past 3 years, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
  • Prior therapy with gemcitabine or carboplatin in the metastatic setting. Patients having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented >6 months after the last exposure to the drug(s)
  • Requirement of chronic use of immunosuppressive agents
  • HIV, hepatitis B or hepatitis C infection
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01201265
ML25420
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