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Monoclonal Antibodies

Combination Therapy for Inflammatory Breast Cancer

Phase 2

Waitlist Available

Led By Vicente Valero

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with recurrent or metastatic IBC after standard systemic therapy are eligible

Confirmed diagnosis of inflammatory breast cancer according to international consensus criteria

Must not have

History of certain pulmonary conditions

COBIMETINIB-SPECIFIC EXCLUSION CRITERIA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is studying a combination of immunotherapy, targeted therapy, and chemotherapy to see if it is more effective than standard chemotherapy in treating patients with metastatic inflammatory breast cancer.

Who is the study for?

This trial is for patients with inflammatory breast cancer that has spread (metastatic) and didn't respond to standard treatments. Participants must have measurable disease, be able to provide a biopsy, agree to use contraception, and meet certain health criteria like heart function and blood counts. They shouldn't have had major surgery recently or used some other cancer therapies.

What is being tested?

The study tests combining atezolizumab (an immune system booster), cobimetinib (a cell growth blocker), and eribulin (chemotherapy) in treating metastatic inflammatory breast cancer. It's a phase II trial aiming to see if this combo is more effective than current treatments.

What are the potential side effects?

Possible side effects include reactions from the immune system such as inflammation in organs, infusion-related reactions, fatigue; liver issues due to cobimetinib; plus typical chemotherapy side effects like hair loss, nausea, low blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer has returned or spread after standard treatment.

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My breast cancer is officially diagnosed as inflammatory.

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I am fully active or can carry out light work.

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I have a cancer spread that can be biopsied.

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My cancer's hormone receptor status is known.

Exclusion Criteria

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

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I have a history of lung problems.

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I am not excluded from taking Cobimetinib.

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I am currently using or have used specific cancer treatments.

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I still have side effects from previous cancer treatments.

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I have not had any other cancers in the last 5 years.

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I do not have significant liver disease and am not pregnant or breastfeeding.

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I have an autoimmune disease or immune deficiency.

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I have not received a live flu vaccine recently.

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I have not had major surgery in the last 28 days.

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I have not had severe allergic reactions to medications.

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I have had an organ transplant and am on anti-rejection medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

Clinical benefit rate (CBR)

Duration of response (DOR)

Incidence of adverse events

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort II (atezolizumab, eribulin)Experimental Treatment4 Interventions

Patients receive atezolizumab IV over about 30-60 minutes every 3 weeks for cycles 1-6 and every 4 weeks for subsequent cycles, and eribulin IV over 2-5 minutes on days 1 and 8 of cycles 1-6. Cycles 1-6 repeat every 21 days and subsequent cycles with atezolizumab repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Cohort I (atezolizumab, cobimetinib, eribulin)Experimental Treatment5 Interventions

Patients receive atezolizumab IV over about 30-60 minutes every 2 weeks, cobimetinib PO daily for 3 weeks on, 1 week off for 4 weeks of the safety lead-in course. Patients then receive atezolizumab IV over about 30-60 minutes every 2 weeks, cobimetinib PO daily for 3 weeks on, 1 week off, and eribulin IV over 2-5 minutes on days 1 and 8 of cycles 1-4. Cycles 1-4 repeat every 21 days and subsequent cycles with atezolizumab and cobimetinib repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eribulin

FDA approved

Atezolizumab

FDA approved

Cobimetinib

FDA approved

0 / 16Eligibility criteria met