Know Cancer

or
forgot password

A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment


Inclusion Criteria:



- Female patients, >/= 18 years of age

- Histologically confirmed HER2-negative breast cancer

- Disease progression during or following first-line treatment with Avastin and
chemotherapy for locally recurrent or metastatic breast cancer

- Avastin treatment in first-line setting must have been a minimum of 4 cycles (15
mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy

- ECOG performance status 0-2

- At least 28 days since prior radiation therapy or surgery and recovery from treatment

Exclusion Criteria:

- Anti-angiogenic therapy or anti-vascular endothelial growth factors other than
Avastin for first-line treatment

- Active malignancy other than superficial basal cell and superficial squamous cell
carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5
years

- Inadequate renal function

- Clinically relevant cardio-vascular disease

- Known CNS disease except for treated brain metastases

- Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75
mg/day)

- Pregnant or lactating women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Second-line progression-free survival (PFS), tumour assessments according to RECIST criteria by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/bone scans and X-ray

Outcome Time Frame:

approximately 42 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Study ID:

MO22998

NCT ID:

NCT01250379

Start Date:

February 2011

Completion Date:

July 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location