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NCT03498716 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2,199
- Enrollment target
NCT03498716: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03498716 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 2,199 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (185% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03498716, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2,199 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)
Primary Outcome
iDFS was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralatera
Interventions
- DRUG Cyclophosphamide
- DRUG Atezolizumab
- DRUG Paclitaxel
- DRUG Dose-dense Doxorubicin or dose-dense Epirubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,199 participants |
| Start Date | 2018-08-02 |
| Est. Completion | 2023-08-14 |
| Phase | Phase 3 |
Why NCT03498716 stopped before completion
NCT03498716 is an interventional study that assigns participants to a tested intervention. Its 2,199 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (185% higher).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03498716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03498716 about?
NCT03498716 is a clinical study titled "A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer". This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or ep...
What is the current status of trial NCT03498716?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2,199 participants. The study started on 2018-08-02. Estimated completion is 2023-08-14.
What interventions are being tested in trial NCT03498716?
The interventions under investigation include: Cyclophosphamide (DRUG), Atezolizumab (DRUG), Paclitaxel (DRUG), Dose-dense Doxorubicin or dose-dense Epirubicin (DRUG).
Who is sponsoring clinical trial NCT03498716?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03498716's enrollment target sits among peer trials
2,199 95th of 2000 higher than 1,906 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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