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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

Metastatic Breast Cancer

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

📊
1 of 1132 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

COMPLETED

Duarte

California

Location available
COMPLETED

La Jolla

California

Location available
WITHDRAWN

Stanford

California

Location available
COMPLETED

Longmont

Colorado

Location available
COMPLETED

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Saint Paul

Minnesota

Location available
RECRUITING

Reno

Nevada

Location available
View Reno location page
WITHDRAWN

Hackensack

New Jersey

Location available
WITHDRAWN

Howell Township

New Jersey

Location available

And 9 more locations available.

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Breast Cancer Trials by City

Browse all breast cancer clinical trials in these cities — not just this study.

Looking for Breast Cancer Treatment in Duarte?

Join others in California exploring innovative treatment options through clinical research

Breast Cancer Treatment Options in Duarte, California

If you're searching for Breast Cancer treatment in Duarte, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Duarte, La Jolla, Stanford and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Breast Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 1132 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Breast Cancer?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Breast Cancer

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Breast Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT03424005. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.