A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT04148911
Phase
PHASE3
Status
Completed

Conditions

  • Triple-Negative Breast Cancer

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 of every 28-day cycle. Day 15: Atezolizumab may be administered on Days 15-18 of each cycle.
  • Nab-Paclitaxel — DRUG
    Nab-Paclitaxel will be administered at the 100 mg/m2 dose via IV infusion on Days 1, 8, and 15 of every 28-day cycle. Day 8: Nab-paclitaxel may be administered on Days 8-11 of each cycle. Day 15: Nab-paclitaxel may be administered on Days 15-18 of each cycle, on the same day with the atezolizumab infusion.

Study Details

Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease.

Key Dates

Start date
Dec 10, 2019
Status verified
Dec 2025
Primary completion
Dec 15, 2024
Completion
Dec 15, 2024

Study Design

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

Arms

  • Experimental: Atezolizumab plus Nab-Paclitaxel
    Participants will receive Atezolizumab via intravenous (IV) infusion on Days 1 and 15 of every 28-day cycle in combination with Nab-Paclitaxel on Days 1, 8, and 15 (individually selected by the investigator) until disease progression, or unacceptable toxicity, additionally until loss of clinical benefit as determined by the investigator or participant decision to discontinue treatment.

Primary Outcome Measure

Percentage of Participants With Treatment-emergent Grade ≥3 Adverse Events (AEs) [ Time Frame: Up to 60 months ]

Related coverage on Hipa.ai

Related Studies