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Monoclonal Antibodies

Atezolizumab + Standard Therapy for HER2-Positive Breast Cancer

Phase 3

Waitlist Available

Led By Charles E Geyer

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Patients not receiving anti-coagulant therapy must have specific prothrombin time (PT) and international normalized ratio (INR) values

Must not have

Patients with brain metastases are excluded if they meet ANY of the specified criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 months up to 8 years

Awards & highlights

Pivotal Trial

Summary

This trial is studying how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic).

Who is the study for?

This trial is for adults with HER2-positive metastatic breast cancer. Eligible participants have a tumor no larger than 3 cm, four or fewer brain metastases, measurable disease, and proper organ function. HIV-positive patients can join if they're on effective therapy. Pregnant women, those planning pregnancy, or lactating are excluded.

What is being tested?

The study tests how well the usual therapy (paclitaxel, trastuzumab, pertuzumab) works with or without atezolizumab in treating first-line HER2-positive metastatic breast cancer. It's a randomized phase III trial where some patients will also receive a placebo instead of atezolizumab.

What are the potential side effects?

Atezolizumab may cause immune-related side effects like inflammation in various organs; infusion reactions; fatigue; nausea; liver issues; skin rash and itching. The chemotherapy drugs can cause hair loss, nerve damage, 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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I am fully active or can carry out light work.

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My blood clotting tests are within the required range.

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My breast cancer has spread outside the brain and cannot be surgically removed.

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My cancer can be measured and has not been treated with radiation.

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I have brain metastases and meet all required criteria.

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My largest tumor is 3 cm or smaller.

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I have up to four cancer spread sites in my brain.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have brain metastases that meet exclusion criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 months up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 months up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months up to 8 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

Progression free survival

Secondary study objectives

Frequency of adverse events, including late immune-related toxicities

Overall objective response

Overall survival

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (pertuzumab, trastuzumab, taxane therapy, atezolizumab)Experimental Treatment10 Interventions

Patients receive pertuzumab IV over 30-60 minutes on days 1 and 22, trastuzumab IV over 30-90 minutes on days 1 and 22, and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, and 36 or docetaxel IV over 60 minutes on days 1 and 22. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 22 of cycle 1 and days 1 and 22 of subsequent cycles. Cycles repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo a biopsy at baseline. Patients undergo a CT or MRI at baseline, prior to weeks 10, 19, 28 and then at 9, 12, 15, 18, 21, and 24 months from study entry, every 3 months through year 3, every 6 months for years 4 and 5, and then every 6 months for years 6 through 10 from study entry. Patients undergo a bone scan at baseline, every 6 months from study entry, every 6 months through year 3, and every 12 months for years 4 and 5.

Group II: Arm II (pertuzumab, trastuzumab, taxane therapy, placebo)Active Control10 Interventions

Patients receive pertuzumab, trastuzumab, and paclitaxel or docetaxel as in Arm I. Patients also receive placebo IV 30-60 minutes on day 1 of cycle 22 and days 1 and 22 of subsequent cycles. Cycles repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo a biopsy at baseline. Patients undergo a CT or MRI at baseline, prior to weeks 10, 19, 28 and then at 9, 12, 15, 18, 21, and 24 months from study entry, every 3 months through year 3, every 6 months for years 4 and 5, and then every 6 months for years 6 through 10 from study entry. Patients undergo a bone scan at baseline every 6 months from study entry, every 6 months through year 3, and every 12 months for years 4 and 5.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Trastuzumab

2014

Completed Phase 4

~5190