Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments bevacizumab [avastin], chemotherapy
Phase phase 3
Sponsor Hoffmann-La Roche
Start date February 2011
End date April 2015
Trial size 494 participants
Trial identifier NCT01250379, 2010-020998-16, MO22998

Summary

This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
chemotherapy
Standard chemotherapy (doublets not allowed)
(Experimental)
bevacizumab [avastin]
10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
chemotherapy
Standard chemotherapy (doublets not allowed)

Primary Outcomes

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
time frame: approximately 42 months

Secondary Outcomes

Measure
Third-line PFS, tumour assessments according to RECIST criteria by CT/MRI/bone scan and X-ray
time frame: approximately 42 months
Second-line Overall Response Rate (ORR), tumour assessments according to RECIST criteria by CT/MRI/bone scan and x-ray
time frame: approximately 42 months
One-year survival
time frame: approximately 42 months
Overall survival (OS)
time frame: approximately 42 months
Quality of life: Functional assessment of cancer therapy - breast (FACT-B) scale, EuroQuol (EQ-5D) questionnaire
time frame: approximately 42 months
Safety: Incidence of adverse events
time frame: approximately 42 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.