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Monoclonal Antibodies

Atezolizumab + Chemotherapy for HER2-Positive Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women diagnosed with pathologically confirmed HER2-overexpressing breast cancer, that is locally recurrent, unresectable or metastatic (negative or positive for ER/PR, and positive for HER2)
HER2 status confirmed positive by means of immunohistochemistry (IHC) or in situ hybridization (ISH) according to ASCO/CAP 2013 guidelines
Must not have
Patients with tumors that cannot be measured or clinically followed
Patients with active central nervous system (CNS) metastases and/or carcinomatous meningitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after the last patient stops treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat HER2-overexpressing breast cancer. The new combination includes atezolizumab, which may help the immune system better recognize and kill cancer cells. The trial will test the safety and efficacy of this new combination in 50 patients.

Who is the study for?
This trial is for women over 18 with HER2-positive breast cancer that's advanced and can't be removed by surgery. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and not have had certain treatments or conditions that could interfere with the study.
What is being tested?
The trial tests atezolizumab combined with paclitaxel, trastuzumab, and pertuzumab in patients with metastatic HER-2 positive breast cancer. It aims to see how safe this combination is and how well it works without long-term corticosteroid use.
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drugs being administered into a vein, fatigue, blood disorders like low counts of different types of cells, liver issues indicated by changes in certain test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman with HER2-positive breast cancer that cannot be surgically removed or has spread.
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My cancer is HER2 positive based on specific tests.
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I have at least one tumor that can be measured on a CT scan.
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I am older than 18 years.
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I can take care of myself and am up and about more than half of my waking hours.
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My blood counts and organ functions are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My tumor cannot be measured or monitored with current methods.
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I have active brain metastases or cancer in the lining of my brain.
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I am not currently taking herbal medications, immunomodulators, immunosuppressants, corticosteroids, or anti-TNF-α drugs.
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I have a lung condition not caused by an infection.
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I have previously been treated with specific immune therapies.
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I have not received any live vaccines in the last 28 days and agree to avoid them during and for 90 days after treatment.
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I have moderate nerve damage.
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I am currently on medication for an infection.
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I will stop taking RANKL inhibitors (like denosumab) but can continue bisphosphonates.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years after the last patient stops treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after the last patient stops treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Antitumor activity of atezolizumab plus the standard regimen of paclitaxel, trastuzumab, and pertuzumab
Number of participants with treatment-related adverse events
Secondary study objectives
Cardiac safety
Clinical benefit rate (CBR)
Correlation of biomarkers related to PD-L1 blockade with objective response rate (ORR), CBR, PFS, OS, and DOR.
+8 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Investigational ArmExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pertuzumab
2014
Completed Phase 3
~7500
Atezolizumab
2016
Completed Phase 3
~5860
Paclitaxel
2011
Completed Phase 4
~5450
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,560 Previous Clinical Trials
569,438 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,357 Total Patients Enrolled
15 Trials studying Breast Cancer
4,082 Patients Enrolled for Breast Cancer

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03125928 — Phase 2
Breast Cancer Research Study Groups: Investigational Arm
Breast Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03125928 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03125928 — Phase 2
~2 spots leftby Nov 2025
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