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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%

Must not have

History of leptomeningeal disease

Significant cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of cycles 1, 3 5, 7, 9, and 11 and every third cycle thereafter pre-treatment and 30 minutes after sacituzumab govitecan infusion (cycle = 21 days); 30 days after last dose

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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 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 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 am eligible for treatment with capecitabine alone.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer spread to the lining of my brain and spinal cord.

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I have a serious heart condition.

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I haven't taken any immune-weakening medication in the last 2 weeks.

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I have not taken sorivudine or similar drugs.

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I do not have congenital long QT syndrome.

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My body lacks the enzyme dihydropyrimidine dehydrogenase.

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I couldn't tolerate atezolizumab in the first stage of treatment.

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I have had a previous transplant of stem cells or an organ.

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I haven't had any biological treatment or other systemic treatments for TNBC in the last 2 weeks or longer.

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I have previously received treatments that boost the immune system to fight cancer.

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I am not eligible for the 2L CIT-naive cohort, Stage 1.

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I am not eligible for Stage 1 or Stage 2 of the trial.

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I frequently need procedures to remove excess fluid from my body.

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I have brain metastases that are untreated or getting worse.

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I have pain from my cancer that isn't managed well.

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I have active tuberculosis.

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I have been treated with capecitabine before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 cycles 1-2: pre-treatment and 30 minutes after sgn-liv1a infusion; days 8 and 15, cycle 1 at visit; day 1 of cycles 3, 4, 8, 12, and 16 pretreatment (cycle = 21 days); 30 days after last dose of sgn-liv1a; 120 days after last dose of atezolizumab

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 cycles 1-2: pre-treatment and 30 minutes after sgn-liv1a infusion; days 8 and 15, cycle 1 at visit; day 1 of cycles 3, 4, 8, 12, and 16 pretreatment (cycle = 21 days); 30 days after last dose of sgn-liv1a; 120 days after last dose of atezolizumab

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 cycles 1-2: pre-treatment and 30 minutes after sgn-liv1a infusion; days 8 and 15, cycle 1 at visit; day 1 of cycles 3, 4, 8, 12, and 16 pretreatment (cycle = 21 days); 30 days after last dose of sgn-liv1a; 120 days after last dose of atezolizumab for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Plasma Concentration of Ipatasertib

Plasma or Serum Concentration of SGN-LIV1A

Serum Concentration of Atezolizumab

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups

Experimental Treatment

Active Control

Group I: Inavolisib + Ribociclib (dose #2) + LetrozoleExperimental Treatment3 Interventions

Hormone receptor-positive (HR+) participants will receive treatment with inavolisib plus ribociclib plus letrozole until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Group II: Inavolisib + Ribociclib (dose #2) + 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 III: Inavolisib + Ribociclib (dose #1) + LetrozoleExperimental Treatment3 Interventions

Group IV: Inavolisib + Ribociclib (dose #1) + FulvestrantExperimental Treatment2 Interventions

Group V: Inavolisib + Abemaciclib + LetrozoleExperimental Treatment2 Interventions

Hormone receptor-positive (HR+) participants will receive treatment with inavolisib plus abemaciclib plus letrozole until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Group VI: 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 VII: Inavolisib (dose #2) + Trastuzumab DeruxtecanExperimental Treatment1 Intervention

HER2+/HER2-low participants will receive inavolisib + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

Group VIII: Inavolisib (dose #1) + Trastuzumab DeruxtecanExperimental Treatment2 Interventions

HER2+/HER2-low participants will receive inavolisib + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

Group IX: 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 X: 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 XI: 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 XII: 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 XIII: 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 XIV: 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 XV: 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 XVI: 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

Letrozole

2002

Completed Phase 4

~3590

Ipatasertib

2017

Completed Phase 3

~3630