A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple Negative Breast Cancer (IMpassion130)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02425891
First received: April 21, 2015
Last updated: July 1, 2016
Last verified: July 2016
  Purpose
This study is being conducted to determine the efficacy and safety in using Atezolizumab in combination with nab-paclitaxel in treating participants with metastatic breast cancer. The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with metastatic breast cancer, and preliminary data shows the use of Atezolizumab is safe to use in combination with chemotherapy.

Condition Intervention Phase
Metastatic Breast Cancer, Triple Negative Breast Cancer
Drug: Atezolizumab
Drug: Nab-Paclitaxel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab Paclitaxel Compared With Placebo With Nab Paclitaxel for Patients With Previously Untreated Metastatic Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Up to 53 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Up to 53 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Up to 53 months ] [ Designated as safety issue: No ]
  • Duration of Objective Response (DOR) [ Time Frame: Up to 53 months ] [ Designated as safety issue: No ]
  • Time to Deterioration (TTD) in Global Health Status/Health-Related Quality of Life (HRQoL) [ Time Frame: Up to 53 months ] [ Designated as safety issue: No ]
  • Percentage of Participants with Adverse Events (AEs), including Serious AEs and Non-Serious AEs [ Time Frame: Up to 53 months ] [ Designated as safety issue: No ]
  • Percentage of Participants with Clinically Significant Changes in Safety Measurements, Including Vital Signs, Physical Findings and Clinical Laboratory Results [ Time Frame: Up to 53 months ] [ Designated as safety issue: No ]
  • Percentage of Anti-Therapeutic Antibody (ATA) Response to Atezolizumab [ Time Frame: Up to 53 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: June 2015
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Atezolizumab plus nab-paclitaxel
Drug: Atezolizumab
An engineered anti-PDL1 antibody; Day 1 and Day 15 of every cycle, participants will receive atezolizumab 840 mg administered by IV infusion every two weeks (every 14 (+/-3) days)
Other Name: MPDL3280A
Drug: Nab-Paclitaxel
Administered alone intravenously on days 1, 8, and 15 of each 28-day cycle, with a starting dose of 100 mg/m2
Placebo Comparator: 2
Placebo and nab-paclitaxel
Drug: Nab-Paclitaxel
Administered alone intravenously on days 1, 8, and 15 of each 28-day cycle, with a starting dose of 100 mg/m2
Drug: Placebo
On Day 1 and Day 15 of every cycle, participants will receive 840 mg placebo administered by IV infusion every 14 (+/- 3) days

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female > or = 18 years of age
  • Metastatic or locally advanced, histologically documented Triple-Negative Breast Cancer (TNBC)
  • No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease
  • Adequate hematologic and end-organ function

Exclusion Criteria:

  • Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
  • Leptomeningeal disease
  • Pregnancy or lactation
  • History of autoimmune disease
  • Prior allogeneic stem cell or solid organ transplantation
  • Positive test for HIV
  • Active hepatitis B or hepatitis C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02425891

Contacts
Contact: Reference Study ID Number: WO29522 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 287 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02425891     History of Changes
Other Study ID Numbers: WO29522  2014-005490-37 
Study First Received: April 21, 2015
Last Updated: July 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016