A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
Public ClinicalTrials.gov record NCT03280563. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Hormone Receptor-Positive HER2-Negative Breast Cancer (MORPHEUS-HR+ Breast Cancer)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03280563
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 144 participants
Conditions and interventions
Conditions
Interventions
- Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody Drug
- Bevacizumab Drug
- Entinostat Drug
- Exemestane Drug
- Fulvestrant Drug
- Ipatasertib Drug
- Tamoxifen Drug
- Abemaciclib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 22, 2017 (Actual)
- Primary completion
- Sep 26, 2024 (Actual)
- Completion
- Sep 26, 2024 (Actual)
- Last update posted
- Nov 10, 2025
2017 – 2024
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| UCSF Helen Diller Family CCC | San Francisco | California | 94158 | — |
| Stanford Cancer Institute | Stanford | California | 94305-5456 | — |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Wellness Oncology and Hematology - Main Office | West Hills | California | 91307 | — |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | — |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Providence Cancer Center | Portland | Oregon | 97231 | — |
| UPMC Pinnacle Health System | Harrisburg | Pennsylvania | 17102 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Univ of Pittsburgh Sch of Med | Pittsburgh | Pennsylvania | 15213 | — |
| Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03280563, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 10, 2025 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03280563 live on ClinicalTrials.gov.