NCT03424005 · Hoffmann-La Roche
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(Morpheus-panBC)
What this study is about
This is an umbrella study evaluating the effectiveness and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.
View original scientific description
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.
Interventions
DRUG
Capecitabine
Capecitabine will be administered 1250 milligrams per square meter (mg/m\^2) orally twice daily on Days 1-14 of each 21-day cycle.
DRUG
Atezolizumab
For Atezolizumab + SGN-LIV1A, Atezolizumab + Sacituzumab Govitecan, or Atezolizumab + Chemo arms: atezolizumab will be administered intravenously (IV), 1200 mg, on Day 1 of each 21-day cycle. For Atezolizumab + Nab-Paclitaxel, Atezolizumab + Selicrelumab + Bevacizumab, Atezolizumab + Ipatasertib, or Atezolizumab + Nab-Paclitaxel + Tocilizumab arms: atezolizumab will be administered IV, 840 mg on Days 1 and 15 of each 28-day cycle.
DRUG
Ipatasertib
Ipatasertib will be administered by mouth 400 mg once a day, on Days 1-21 of each 28-day cycle.
DRUG
SGN-LIV1A
SGN-LIV1A will be administered IV, 2.5 milligrams per kilogram (mg/kg) (maximum calculated dose 250 mg), on Day 1 of each 21-day cycle.
DRUG
Bevacizumab
Bevacizumab will be administered IV, 10 mg/kg, on Days 1 and 15 of each 28-day cycle.
DRUG
Chemotherapy (Gemcitabine + Carboplatin or Eribulin)
Gemcitabine will be administered by IV, 1000 mg/m\^2, along with carboplatin, by IV, on Days 1 and 8 of each 21-day cycle. Or Eribulin will be administered IV, 1.4 mg/m\^2 on Days 1 and 8 of each 21-day cycle.
DRUG
Selicrelumab
Selicrelumab will be administered by subcutaneous (SC) injection, at a fixed dose of 16 mg on Day 1 of Cycles 1 to 4 and every third cycle thereafter (Cycle = 28 days).
DRUG
Tocilizumab
Tocilizumab will be administered IV, 8 mg/kg on Day 1 of each 28-day cycle.
DRUG
Nab-Paclitaxel
Nab-Paclitaxel will be administered IV, 100 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
DRUG
Sacituzumab Govitecan
Sacituzumab govitecan will be administered by IV infusion, 10 mg/kg, on Days 1 and 8 of each 21-day cycle.
DRUG
Abemaciclib
Abemaciclib tablets will be administered at a dose of 150 mg twice daily by mouth on Days 1-28 of each 28-day cycle.
DRUG
Fulvestrant
For Inavolisib + Abemaciclib + Fulvestrant, Inavolisib + Ribociclib (Dose #1) + Fulvestrant, Inavolisib + Ribociclib (Dose #2) + Fulvestrant, or Inavolisib + Atirmociclib + Fulvestrant arms: Fulvestrant 500 mg, administered as an IM injection on Days 1 and 15 of Cycle 1, followed by Day 1 of each 28-day cycle thereafter. For Empa + Inavolisib + Fulvestrant ± Palbociclib, or Metformin + Inavolisib + Fulvestrant ± Palbociclib arms: Fulvestrant 500 mg, administered as an IM injection on Day 1 and as per local prescribing guidelines thereafter.
DRUG
Ribociclib (Dose #1)
Ribociclib tablets will be administered by mouth once daily.
DRUG
Inavolisib (Dose #1)
Inavolisib tablets will be administered by mouth once daily.
DRUG
Trastuzumab Deruxtecan
Trastuzumab Deruxtecan will be administered IV, 5.4 mg/kg on Day 1 of each 21-day cycle.
DRUG
Ribociclib (Dose #2)
Ribociclib tablets will be administered by mouth once daily.
DRUG
Letrozole
Letrozole tablets will be administered at a dose of 2.5 mg once a day by mouth on Days 1-28 of each 28-day cycle.
DRUG
Inavolisib (Dose #2)
Inavolisib tablets will be administered by mouth OD.
DRUG
Empagliflozin
Empagliflozin, administered orally, once daily (QD)
DRUG
Palbociclib
For Empagliflozin + Inavolisib + Fulvestrant ± Palbociclib arm: Palbociclib 125 mg administered orally, QD in Cycle 1 followed by 125 mg on Days 1-21 of each cycle. For Metformin + Inavolisib + Fulvestrant ± Palbociclib arm: Palbociclib 125 mg administered orally, QD in Cycle 1, followed by 125 mg on Days 1-21 of each cycle (Cycle=28 days).
DRUG
Metformin
Metf 1000 mg administered orally QD.
DRUG
Atirmociclib
Atirmociclib administered orally, BID on Days 1-28 for each 28-day cycle.
DRUG
Giredestrant
Giredestrant 30 mg will be administered by mouth once daily, on Days 1-28 of each 28-day cycle.
Primary outcome measures
Objective Response Rate (ORR)
Time frame: Baseline until disease progression or loss of clinical benefit (up to approximately 12 years)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):
- Age \>/= 18 years at the time of signing Informed Consent Form
- ECOG Performance Status of 0 or 1
- Able to comply with the study protocol, in the investigator's judgment
- Metastatic or inoperable locally advanced breast cancer
- Measurable disease (at least one target lesion) according to RECIST v1.1
- Life expectancy \>/= 3 months, as determined by the investigator
- Tumor accessible for biopsy, unless archival tissue is available
- Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive me
Where
- Duarte, California
- La Jolla, California
- Stanford, California
- Longmont, Colorado
- Tampa, Florida
- Saint Paul, Minnesota
- Reno, Nevada
- Hackensack, New Jersey
- Howell Township, New Jersey
- New Brunswick, New Jersey
- New York, New York
- Philadelphia, Pennsylvania
And 5 more locations — see the full list below.
Collaborators
Gilead Sciences, Pfizer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations