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NCT03280563 · ClinicalTrials.gov registry record · Phase 1
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
A Phase 1 study of Breast Neoplasms, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
- 20
- Study locations
NCT03280563: Completed Phase 1 study of Breast Neoplasms, sponsored by Hoffmann-La Roche.
NCT03280563 is a Phase 1 study of Breast Neoplasms that has completed, run by Hoffmann-La Roche. The registered enrollment target is 144 participants, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03280563, a Phase 1 study of Breast Neoplasms, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.
Primary Outcome
Objective response rate (ORR) was defined as the percentage of participants with an objective response of complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) that have a reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Exemestane
- DRUG Fulvestrant
- DRUG Entinostat
- DRUG Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Study Locations (20)
Other
- Rambam Medical Center - Haifa
- Shaare Zedek Medical Center - Jerusalem
- Rabin Medical Center-Beilinson Campus - Petah Tikva
- Sheba Medical Center - Ramat Gan
- Tel Aviv Sourasky Medical Center - Tel Aviv
- National Cancer Center - Gyeonggi-do
California
- UCSF Helen Diller Family CCC - San Francisco
- Stanford Cancer Institute - Stanford
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center - Torrance
- Wellness Oncology and Hematology - Main Office - West Hills
Pennsylvania
- UPMC Pinnacle Health System - Harrisburg
- Thomas Jefferson University Hospital - Philadelphia
- Univ of Pittsburgh Sch of Med - Pittsburgh
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Northwest Georgia Oncology Centers PC - Marietta - Marietta
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore
New York
- Memorial Sloan Kettering Cancer Center - New York
North Carolina
- Levine Cancer Institute - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2017-12-22 |
| Est. Completion | 2024-09-26 |
| Phase | Phase 1 |
What the finished NCT03280563 record still lists
NCT03280563 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.
NCT03280563 names 20 study sites across 10 states, led by Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03280563 about?
NCT03280563 is a clinical study titled "A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer". This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-...
What is the current status of trial NCT03280563?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2017-12-22. Estimated completion is 2024-09-26.
What conditions does trial NCT03280563 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT03280563?
The interventions under investigation include: Bevacizumab (DRUG), Exemestane (DRUG), Fulvestrant (DRUG), Entinostat (DRUG), Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody (DRUG).
Who is sponsoring clinical trial NCT03280563?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03280563 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03280563's enrollment target sits among peer trials
144 47th of 97 higher than 51 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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.
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