First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC

Sponsor
MedSIR
Study ID
NCT04408118
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab (840 mg) will be administered intravenously on Days 1 and 15. The first infusion of atezolizumab will be administered over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.
  • Paclitaxel — DRUG
    Will be administered on days 1, 8 and 15 via IV infusion over 1 hour.
  • Bevacizumab — DRUG
    Will be administered intravenously over 30-90 minutes on Days 1 and 15.

Study Details

This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate to evaluate the efficacy and safety of first line atezolizumab in combination with paclitaxel and bevacizumab (Avastin®) in patients with advanced or metastatic triple-negative breast cancer (mTNBC)

Key Dates

Start date
Oct 5, 2020
Status verified
Dec 2023
Primary completion
Dec 7, 2023
Completion
Dec 7, 2023

Study Design

Enrollment
100 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Paclitaxel + Bevacizumab (Avastin®)
    All eligible patients will be treated with atezolizumab (840 mg) intravenously on days 1 and 15, Paclitaxel (90 mg/m2) on days 1, 8 and 15 via IV infusion and Bevacizumab (Avastin® 10mg/kg) intravenously on days 1 and 15. Treatment cycles and patient visits are organized in scheduled cycles of 28 days.

Primary Outcome Measure

PFS (Progression-free Survival) [ Time Frame: 24 months ]

Related Studies