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NCT03800836 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 139
- Enrollment target
- 18
- Study locations
NCT03800836: Completed Phase 1 study of Breast Cancer, sponsored by Hoffmann-La Roche.
NCT03800836 is a Phase 1 study of Breast Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 139 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 18 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03800836, a Phase 1 study of Breast Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 139 participants
- Enrollment target
- 18
- Study locations
Study Summary
This is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy. In Cohort 2, ipatasertib and atezolizumab (with no chemotherapy), will be administered to participants with locally advanced or metastatic TNBC. In Cohort 3, the safety and efficacy of neoadjuvant ipatasertib, atezolizumab, doxorubicin and cyclophosphamide (AC) (Ipat + Atezo + AC) followed by Ipat + Atezo + Pac will be evaluated in participants with locally advanced Type 2-4 (T2-4) TNBC. In Cohort 4, the safety and efficacy of Ipat + Atezo + Pac will be evaluated in participants with PD-L1 (Programmed Death-Ligand-1) positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting.
Primary Outcome
Objective Response Rate: percentage participants with confirmed complete response (CR) or partial response (PR) on 2 consecutive occasions \>or= 4 weeks apart, as determined by investigator according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Percentages have been rou
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Ipatasertib
- DRUG Paclitaxel
- DRUG Nab-Paclitaxel
- DRUG AC
Study Locations (18)
Other
- Institut de Cancerologie de l Ouest - Angers
- Institut Bergonie - Bordeaux
- Centre Georges Francois Leclerc - Dijon
- Institut Curie - Paris
- Gustave Roussy - Villejuif
- Hospital de la Santa Creu i Sant Pau - Barcelona
- Hospital Universitario La Paz - Madrid
- Hospital Clinico San Carlos; Servicio de Oncologia - Madrid
- Hospital Universitario Fundacion Jimenez Diaz. - Madrid
- Hospital Universitario 12 de Octubre - Madrid
- Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica - Madrid
- Hospital Universitario Virgen del Rocío - Seville
- Barts Cancer Institute - London
- Nottingham University Hospitals NHS Trust - Nottingham
Victoria
- Austin Hospital - Heidelberg
- Peter MacCallum Cancer Center - North Melbourne
California
- Pacific Shores Medical Group - Long Beach
New South Wales
- St Vincents Hospital; Cardiopulmonary transplant Ambulatory Care Dept - Darlinghurst
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2018-02-13 |
| Est. Completion | 2022-03-16 |
| Phase | Phase 1 |
What the finished NCT03800836 record still lists
NCT03800836 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT03800836 lists 18 locations in 4 states (Other, Victoria, California).
Frequently Asked Questions
What is clinical trial NCT03800836 about?
NCT03800836 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer". This is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer ...
What is the current status of trial NCT03800836?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 139 participants. The study started on 2018-02-13. Estimated completion is 2022-03-16.
What conditions does trial NCT03800836 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03800836?
The interventions under investigation include: Atezolizumab (DRUG), Ipatasertib (DRUG), Paclitaxel (DRUG), Nab-Paclitaxel (DRUG), AC (DRUG).
Who is sponsoring clinical trial NCT03800836?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03800836 being conducted?
This trial has 18 study locations across California, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03800836's enrollment target sits among peer trials
139 469th of 1224 higher than 755 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
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