A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Public ClinicalTrials.gov record NCT03424005. 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 Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study: Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \[1L\] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-naïve cohort). Cohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations. Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.
Study identification
- NCT ID
- NCT03424005
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 1,132 participants
Conditions and interventions
Conditions
Interventions
- Capecitabine Drug
- Atezolizumab Drug
- Ipatasertib Drug
- SGN-LIV1A Drug
- Bevacizumab Drug
- Chemotherapy (Gemcitabine + Carboplatin or Eribulin) Drug
- Selicrelumab Drug
- Tocilizumab Drug
- Nab-Paclitaxel Drug
- Sacituzumab Govitecan Drug
- Abemaciclib Drug
- Fulvestrant Drug
- Ribociclib (Dose #1) Drug
- Inavolisib (Dose #1) Drug
- Trastuzumab Deruxtecan Drug
- Ribociclib (Dose #2) Drug
- Letrozole Drug
- Inavolisib (Dose #2) Drug
- Empagliflozin Drug
- Palbociclib Drug
- Metformin Drug
- Atirmociclib Drug
- Giredestrant Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Mar 29, 2018
- Primary completion
- Sep 29, 2030
- Completion
- Sep 29, 2030
- Last update posted
- Aug 11, 2026
2018 – 2030
United States locations
- U.S. sites
- 20
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | Completed |
| University of California San Diego (UCSD) - Koman Family Outpatient Pavilion ? La Jolla | La Jolla | California | 92093-1350 | Recruiting |
| University of California San Diego Medical Center | La Jolla | California | 92093 | Completed |
| Stanford Cancer Institute | Stanford | California | 94305 | Withdrawn |
| Rocky Mountain Cancer Center - Longmont | Longmont | Colorado | 80501 | Completed |
| H. Lee Moffitt Cancer Center and Research Inst. | Tampa | Florida | 33612 | Completed |
| Metro-Minnesota Community Oncology Research Consortium | Saint Paul | Minnesota | 55101-2502 | Recruiting |
| Renown Regional Medical Center | Reno | Nevada | 89502-1576 | Recruiting |
| Hackensack Univ Medical Center | Hackensack | New Jersey | 07601 | Withdrawn |
| Regional Cancer Care Associates, LLC | Howell Township | New Jersey | 07731 | Withdrawn |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | Withdrawn |
| NYU Langone Medical Center | New York | New York | 10016 | Withdrawn |
| Duke Cancer Institute | Durham | North Carolina | 27710-2000 | Recruiting |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Withdrawn |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | Withdrawn |
| Tennessee Oncology - Chattanooga Oncology & Hematology Associates | Chattanooga | Tennessee | 37404 | Recruiting |
| The West Clinic | Germantown | Tennessee | 38138 | Recruiting |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | Recruiting |
| Texas Oncology-Plano East | Plano | Texas | 75075-7787 | Withdrawn |
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 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03424005, 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 Aug 11, 2026 · Synced Sep 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03424005 live on ClinicalTrials.gov.