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NCT04177108 · ClinicalTrials.gov registry record · Phase 3

A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

A Phase 3 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
242
Enrollment target

NCT04177108: Completed Phase 3 study, sponsored by Hoffmann-La Roche.

NCT04177108 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 242 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04177108, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
242 participants
Enrollment target

Study Summary

This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

Primary Outcome

PFS was defined as the time from randomization to the first occurrence of disease progression as determined locally by RECIST or death from any cause during treatment, whichever occurs first.

Interventions

  • DRUG Atezolizumab
  • DRUG Ipatasertib
  • DRUG Paclitaxel
  • DRUG Placebo for Atezolizumab
  • DRUG Placebo for Ipatasertib

Trial Details

FieldValue
Enrollment Target 242 participants
Start Date 2019-11-25
Est. Completion 2023-02-28
Phase Phase 3
Hoffmann-La Roche

909 total trials

What the finished NCT04177108 record still lists

NCT04177108 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 5 interventions - of which Atezolizumab is the first listed.

NCT04177108 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04177108 about?

NCT04177108 is a clinical study titled "A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer". This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

What is the current status of trial NCT04177108?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 242 participants. The study started on 2019-11-25. Estimated completion is 2023-02-28.

What interventions are being tested in trial NCT04177108?

The interventions under investigation include: Atezolizumab (DRUG), Ipatasertib (DRUG), Paclitaxel (DRUG), Placebo for Atezolizumab (DRUG), Placebo for Ipatasertib (DRUG).

Who is sponsoring clinical trial NCT04177108?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04177108's enrollment target sits among peer trials

242 1270th of 2000 higher than 729 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04177108, the US trial registry maintained by the National Library of Medicine. NCT04177108 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.