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NCT02605915 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer
A Phase 1 study of HER2-positive Metastatic Breast Cancer and HER2-Negative Metastatic Breast Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
- 20
- Study locations
NCT02605915: Completed Phase 1 study of HER2-positive Metastatic Breast Cancer and HER2-Negative Metastatic Breast Cancer, sponsored by Hoffmann-La Roche.
NCT02605915 is a Phase 1 study of HER2-positive Metastatic Breast Cancer and HER2-Negative Metastatic Breast Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 98 participants, below the 115-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02605915, a Phase 1 study of HER2-positive Metastatic Breast Cancer and HER2-Negative Metastatic Breast Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without docetaxel) or atezolizumab and trastuzumab emtansine in participants with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) and locally advanced early breast cancer (EBC), and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Atezolizumab
- DRUG Pertuzumab
Study Locations (20)
Pennsylvania
- St. Luke's University Health Network - Bethlehem
- Kimmel Cancer Center Thomas Jefferson University - Philadelphia
- Magee Womens Hospital - Pittsburgh
Tennessee
- Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street - Chattanooga
- West Clinic - Germantown
- Tennessee Oncology - Nashville
North Carolina
- Levine Cancer Institute - Charlotte
- Duke Cancer Center - Durham
Texas
- MD Anderson Cancer Center - Houston
- Cancer Therapy and Research Center CTRC at UTHSCSA - San Antonio
Alabama
- University of Alabama at Birmingham - Birmingham
Arkansas
- University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute - Little Rock
Illinois
- Joliet oncology hematology associates - Joliet
Indiana
- Horizon Oncology Research, Inc. - Lafayette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2015-12-31 |
| Est. Completion | 2019-11-13 |
| Phase | Phase 1 |
What the finished NCT02605915 record still lists
NCT02605915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 115-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (15% lower).
The record links to 3 conditions, with HER2-positive Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT02605915 names 20 study sites across 14 states, led by Pennsylvania, Tennessee, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02605915 about?
NCT02605915 is a clinical study titled "Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer". This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without docetaxel) or atezolizumab and trastuzumab emtansine in participants with ...
What is the current status of trial NCT02605915?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2015-12-31. Estimated completion is 2019-11-13.
What conditions does trial NCT02605915 study?
This clinical trial studies the following conditions: HER2-positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer, Locally Advanced or Early Breast Cancer.
What interventions are being tested in trial NCT02605915?
The interventions under investigation include: Trastuzumab (DRUG), Carboplatin (DRUG), Docetaxel (DRUG), Atezolizumab (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT02605915?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02605915 being conducted?
This trial has 20 study locations across Alabama, Arkansas, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02605915's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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