A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
Public ClinicalTrials.gov record NCT04802759. 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 Breast Cancer (MORPHEUS-BREAST CANCER)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor-positive (ER+), HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting. Cohort 2 will focus on inoperable, locally advanced or metastatic, ER+, HER2-positive breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if recurrence occurred within 6 months of finishing adjuvant therapy) and one was a HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib, lapatinib, pyrotinib, or neratinib). Cohort 3 will focus on inoperable, locally advanced or metastatic, ER+, HER2-negative, PIK3CA-mutated breast cancer with resistance to adjuvant endocrine therapy.
Study identification
- NCT ID
- NCT04802759
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 316 participants
Conditions and interventions
Interventions
- Giredestrant Drug
- Abemaciclib Drug
- Ipatasertib Drug
- Inavolisib Drug
- Ribociclib Drug
- Everolimus Drug
- Samuraciclib Drug
- PH FDC SC Drug
- Palbociclib Drug
- Atezolizumab 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
- Jun 21, 2021
- Primary completion
- May 29, 2029
- Completion
- May 29, 2029
- Last update posted
- Aug 4, 2026
2021 – 2029
United States locations
- U.S. sites
- 12
- U.S. states
- 6
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center | Irvine | California | 92618-2377 | Recruiting |
| University of California, San Francisco (UCSF) | San Francisco | California | 94143 | Recruiting |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Santa Monica | California | 90404 | Recruiting |
| Stanford Cancer Institute (SCI) | Stanford | California | 94305 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Regional Cancer Care Associates LLC (RCCA) - Freehold Location | Freehold | New Jersey | 07728 | Withdrawn |
| Regional Cancer Care Associates LLC ? Howell Division | Howell Township | New Jersey | 07731 | Withdrawn |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | Recruiting |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Recruiting |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15219 | Withdrawn |
| West Cancer Center | Germantown | Tennessee | 38138 | Recruiting |
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 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04802759, 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 4, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04802759 live on ClinicalTrials.gov.