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NCT03726879 · ClinicalTrials.gov registry record · Phase 3
A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 454
- Enrollment target
- 20
- Study locations
NCT03726879 is a Phase 3 study of Breast Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 454 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT03726879, a Phase 3 study of Breast Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 454 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Placebo
- DRUG Atezolizumab
- DRUG Doxorubicin
- DRUG Paclitaxel
Study Locations (20)
Other
- Masarykuv onkologicky ustav - Brno
- Fakultni nemocnice Olomouc; Onkologicka klinika - Olomouc
- Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum - Essen
- Praxis für Interdisziplinäre Onkologie und Hämatologie GbR - Freiburg im Breisgau
- Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem - Hamburg
- Sankt Elisabeth Krankenhaus; Gynaekology - Leipzig
- Rotkreuzklinikum München; Frauenklinik - München
- Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe - Münster
Rio Grande do Sul
- Hospital Nossa Senhora da Conceicao - Porto Alegre
- Hospital Sao Lucas - PUCRS - Porto Alegre
Quebec
- Jewish General Hospital - Montreal
- Hopital du Saint Sacrement - Québec
Missouri
- HCA Midwest Division - Kansas City
New York
- New York University Medical Center PRIME; NYU Langone Medical Center - New York
Tennessee
- Tennessee Oncology - Nashville - Nashville
Estado de Bahia
- Hospital Sao Rafael - HSR - Salvador
Goiás
- Hospital Araujo Jorge; Departamento de Ginecologia E Mama - Goiânia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 454 participants |
| Start Date | 2019-01-11 |
| Est. Completion | 2023-08-24 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03726879
The ClinicalTrials.gov registry entry for NCT03726879 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 454 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (84% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03726879 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Rio Grande do Sul, Quebec.
Frequently Asked Questions
What is clinical trial NCT03726879 about?
NCT03726879 is a clinical study titled "A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer". This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with ear...
What is the current status of trial NCT03726879?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 454 participants. The study started on 2019-01-11. Estimated completion is 2023-08-24.
What conditions does trial NCT03726879 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03726879?
The interventions under investigation include: Cyclophosphamide (DRUG), Placebo (DRUG), Atezolizumab (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT03726879?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03726879 being conducted?
This trial has 20 study locations across Missouri, New York, Tennessee, Estado de Bahia, Goiás. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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