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COMPLETED Phase 3

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)

NCT02425891 · View on ClinicalTrials.gov ↗

Study Summary

This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

Interventions

  • DRUG Placebo
  • DRUG Nab-Paclitaxel
  • DRUG Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

Study Locations (20)

California

  • Kaiser Permanente of Northern California — Oakland
  • Emad Ibrahim, Md, Inc — Redlands
  • Univ of Calif, San Francisco; Breast Cancer Center — San Francisco
  • Kaiser Permanente - San Marcos — San Marcos
  • Cancer Research Collaboration, Inc. — Santa Ana
  • Stanford Univ School of Med; Oncology — Stanford

Florida

  • Florida Cancer Specialists - SCRI; Pharmacy — Fort Myers
  • Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) — Jacksonville
  • The Mount Siani Comprehensive Cancer Center — Miami Beach
  • Florida Cancer Research Institute — Plantation
  • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) — St. Petersburg

Connecticut

  • Yale Cancer Center; Medical Oncology — New Haven
  • Norwalk Hospital — Norwalk
  • Stamford Hospital; BCC, MOHR — Stamford

Alabama

  • University of Alabama at Birmingham — Birmingham

Arkansas

  • Highlands Oncology Group — Springdale

Colorado

  • Kaiser Permanente Of Colorado — Aurora

District of Columbia

  • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) — Washington D.C.

Georgia

  • Northwest Georgia Oncology Centers PC - Marietta — Marietta

Trial Details

FieldValue
Enrollment Target 902 participants
Start Date 2015-06-23
Est. Completion 2021-08-31
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02425891

The ClinicalTrials.gov registry entry for NCT02425891 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 902 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02425891 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02425891 about?

NCT02425891 is a clinical study titled "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 multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cance...

What is the current status of trial NCT02425891?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 902 participants. The study started on 2015-06-23. Estimated completion is 2021-08-31.

What conditions does trial NCT02425891 study?

This clinical trial studies the following conditions: Triple Negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02425891?

The interventions under investigation include: Placebo (DRUG), Nab-Paclitaxel (DRUG), Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02425891?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02425891 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial