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Monoclonal Antibodies

Combination Therapies for Breast Cancer (Morpheus-panBC Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior systemic treatment for metastatic or inoperable locally advanced TNBC
Confirmation of HER2+ or HER2-low status Fasting glucose < 126 mg/dL or < 7.0 mmol/L and HbA1c </= 6.4%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (up to approximately 8 years) as determined by the investigator according to recist v1.1
Awards & highlights

Morpheus-panBC Trial Summary

This trial is testing multiple immunotherapy-based treatment combinations to see if they are effective and safe in patients with metastatic or inoperable TNBC. The study will be performed in two stages, with different cohorts of patients in each stage.

Who is the study for?
This trial is for adults with metastatic or locally advanced breast cancer, including those who haven't had systemic therapy for TNBC, have progressed after first-line chemo, or have HR+/HER2- disease with PIK3CA mutation. Participants must be able to take capecitabine and agree to contraception if of childbearing potential. They should not have received certain prior treatments and must meet specific health criteria.Check my eligibility
What is being tested?
The study tests various treatment combinations (chemotherapy, targeted drugs like Inavolisib and Ribociclib, immunotherapies such as Atezolizumab) in four different patient cohorts based on their type of breast cancer and previous treatments. It's a two-stage trial where patients may switch treatments if they don't benefit from the initial one.See study design
What are the potential side effects?
Potential side effects include reactions related to chemotherapy (nausea, hair loss), targeted therapies (skin rash, high blood sugar), immunotherapies (inflammation in organs), hormonal therapies (hot flashes), and antibody-drug conjugates (fatigue). Specific side effects depend on the treatment combination.

Morpheus-panBC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had any systemic treatment for my advanced triple-negative breast cancer.
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My cancer is HER2 positive or low, and my blood sugar levels are within normal limits.
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My breast cancer cannot be removed by surgery and has spread, and I've had treatments for it before.
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My doctor recommends hormone therapy instead of chemotherapy for my condition.
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I am postmenopausal or willing to undergo hormone therapy if not.
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My cancer has a PIK3CA mutation.
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My breast cancer cannot be removed by surgery and may have spread.
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My tumor can be easily reached for a biopsy.
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I agree to either not have sex or use birth control, and not donate sperm while on treatment.
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My breast cancer has spread and cannot be removed by surgery.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My recent blood and organ function tests are within normal ranges.
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My tumor shows PD-L1 expression of 1% or more.
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I meet all the requirements for Stage 1 and Stage 2 of the trial.
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I can provide a sample of my tumor for testing.
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I am eligible for treatment with capecitabine alone.
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My cancer has a PIK3CA mutation.
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My breast cancer has spread and cannot be removed by surgery.
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My breast cancer has worsened after one round of chemotherapy.

Morpheus-panBC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (up to approximately 8 years) as determined by the investigator according to recist v1.1
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (up to approximately 8 years) as determined by the investigator according to recist v1.1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events
Objective Response Rate (ORR)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Overall Survival (OS)
+2 more
Other outcome measures
Plasma Concentration of Ipatasertib
Plasma or Serum Concentration of SGN-LIV1A
Serum Concentration of Atezolizumab
+4 more

Morpheus-panBC Trial Design

12Treatment groups
Experimental Treatment
Active Control
Group I: Inavolisib + Ribociclib + FulvestrantExperimental Treatment3 Interventions
Hormone receptor-positive (HR+) participants will receive treatment with inavolisib plus ribociclib plus fulvestrant until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Group II: Inavolisib + Abemaciclib + FulvestrantExperimental Treatment3 Interventions
Hormone receptor-positive (HR+) participants will receive treatment with inavolisib plus abemaciclib plus fulvestrant until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Group III: Inavolisib (9 mg) + Trastuzumab DeruxtecanExperimental Treatment2 Interventions
HER2+/HER2-low participants will receive inavolisib (9 mg) + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Group IV: Inavolisib (6 mg) + Trastuzumab DeruxtecanExperimental Treatment2 Interventions
HER2+/HER2-low participants will receive inavolisib (6 mg) + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Group V: Atezolizumab + Selicrelumab + BevacizumabExperimental Treatment3 Interventions
2L-CIT-naive participants will receive doublet combination treatment with atezolizumab plus selicrelumab and bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria. Enrollment is closed.
Group VI: Atezolizumab + Sacituzumab GovitecanExperimental Treatment2 Interventions
1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab plus sacituzumab govitecan until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed.
Group VII: Atezolizumab + SGN-LIV1AExperimental Treatment2 Interventions
2L CIT-naive participants will receive doublet combination treatment with atezolizumab plus SGNLIV1A until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria. Enrollment is closed.
Group VIII: Atezolizumab + Nab-Paclitaxel + TocilizumabExperimental Treatment3 Interventions
1L PD-L1-positive participants will receive combination treatment with atezolizumab plus nab-paclitaxel and tocilizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed.
Group IX: Atezolizumab + IpatasertibExperimental Treatment2 Interventions
2L CIT-naive participants will receive doublet combination treatment with atezolizumab + ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria. Enrollment is closed.
Group X: Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin)Experimental Treatment2 Interventions
2L CIT-naive participants enrolled in the active comparator arm who experience disease progression per RECIST v1.1 and 2L CIT-naive participants enrolled in an experimental arm who experience loss of clinical benefit as determined by the investigator may receive doublet combination treatment with atezolizumab plus chemotherapy (gemcitabine + carboplatin or eribulin) until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed.
Group XI: CapecitabineActive Control1 Intervention
2L CIT-naive participants will receive capecitabine until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1). Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria. Enrollment is closed.
Group XII: Atezolizumab + Nab-PaclitaxelActive Control2 Interventions
1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab + nab-paclitaxel until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840
Ribociclib
2018
Completed Phase 3
~2330
Abemaciclib
2019
Completed Phase 2
~1710
Fulvestrant
2011
Completed Phase 3
~3700
Bevacizumab
2013
Completed Phase 4
~5280
Nab-Paclitaxel
2014
Completed Phase 3
~4340
Inavolisib
2021
Completed Phase 2
~260
Atezolizumab
2016
Completed Phase 3
~6040
Ipatasertib
2019
Completed Phase 3
~2340
Trastuzumab Deruxtecan
2021
Completed Phase 3
~510
Selicrelumab
2014
Completed Phase 1
~240

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,088,909 Total Patients Enrolled
159 Trials studying Breast Cancer
91,225 Patients Enrolled for Breast Cancer
Seagen Inc.Industry Sponsor
206 Previous Clinical Trials
69,097 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer
Gilead SciencesIndustry Sponsor
1,079 Previous Clinical Trials
836,817 Total Patients Enrolled
16 Trials studying Breast Cancer
6,212 Patients Enrolled for Breast Cancer

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03424005 — Phase 1 & 2
Breast Cancer Research Study Groups: Inavolisib (9 mg) + Trastuzumab Deruxtecan, Inavolisib + Ribociclib + Fulvestrant, Inavolisib (6 mg) + Trastuzumab Deruxtecan, Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin), Inavolisib + Abemaciclib + Fulvestrant, Atezolizumab + SGN-LIV1A, Atezolizumab + Selicrelumab + Bevacizumab, Atezolizumab + Nab-Paclitaxel + Tocilizumab, Capecitabine, Atezolizumab + Ipatasertib, Atezolizumab + Nab-Paclitaxel, Atezolizumab + Sacituzumab Govitecan
Breast Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03424005 — Phase 1 & 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03424005 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the standard purpose of Gemcitabine + Carboplatin or Eribulin chemotherapy?

"Chemotherapy, specifically Gemcitabine in conjunction with Carboplatin or Eribulin, is regularly used to treat neoplasm metastasis. It is also an effective treatment for a variety of other conditions like metastatic ureter urothelial carcinoma, lymphoma, non-hodgkin's recurrent cervical cancer."

Answered by AI

How many people are helping to test this new medication?

"Currently, this study is not recruiting patients. However, it was last edited on November 10th, 2022. Additionally, there are 2439 studies actively searching for patients with breast cancer and 2333 trials for Chemotherapy (Gemcitabine + Carboplatin or Eribulin) enrolling participants."

Answered by AI

Are new participants still being accepted into this clinical research project?

"This trial has completed recruitment for its study. However, there are 2439 other trials related to breast cancer and 2333 chemotherapy trials that patients may be eligible for. These studies were active as of the 11th of October, 2022."

Answered by AI

Do we have any precedence for using Gemcitabine + Carboplatin or Eribulin in cancer patients?

"Chemotherapy was first trialed in 1997 at City of Hope Comprehensive Cancer Center. Since then, there have been a total of 3695 completed clinical trials worldwide. Out of these 2333 are presently active, with many taking place in Howell, New jersey."

Answered by AI

In how many hospitals is this trial being conducted?

"Presently, there are 6 sites where recruitment is underway for this trial. They are in Howell, Stanford and Nashville as well as other locations. If you decide to participate in the trial, it would be advantageous to select the site closest to your home to reduce travel burdens."

Answered by AI
~62 spots leftby May 2026