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NCT03371017 · ClinicalTrials.gov registry record · Phase 3

A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer

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

Completed
Registry status
Phase 3
Development phase
595
Enrollment target

NCT03371017: Completed Phase 3 study, sponsored by Hoffmann-La Roche.

NCT03371017 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 595 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03371017, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
595 participants
Enrollment target

Study Summary

This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

Primary Outcome

OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day.

Interventions

  • DRUG Carboplatin
  • DRUG Placebo
  • DRUG Capecitabine
  • DRUG Atezolizumab
  • DRUG Gemcitabine

Trial Details

FieldValue
Enrollment Target 595 participants
Start Date 2018-01-11
Est. Completion 2024-10-23
Phase Phase 3
Hoffmann-La Roche

909 total trials

What the finished NCT03371017 record still lists

NCT03371017 is an interventional study that assigns participants to a tested intervention. The registered 595 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 (23% lower).

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

NCT03371017 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03371017 about?

NCT03371017 is a clinical study titled "A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer". This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

What is the current status of trial NCT03371017?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 595 participants. The study started on 2018-01-11. Estimated completion is 2024-10-23.

What interventions are being tested in trial NCT03371017?

The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Capecitabine (DRUG), Atezolizumab (DRUG), Gemcitabine (DRUG).

Who is sponsoring clinical trial NCT03371017?

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 NCT03371017's enrollment target sits among peer trials

595 640th of 2000 higher than 1,359 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 NCT03371017, the US trial registry maintained by the National Library of Medicine. NCT03371017 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.