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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after the last patient stops treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 agree to use birth control or abstain from sex during and for 7 months after the study.
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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.
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I have had one hormonal treatment for my advanced cancer.
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I finished my early-stage cancer treatment over a year ago.
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I can provide a new biopsy sample from my metastatic cancer and am open to a repeat biopsy after treatment.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antitumor activity of atezolizumab plus the standard regimen of paclitaxel, trastuzumab, and pertuzumab
Number of participants with treatment-related adverse events
Secondary outcome measures
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
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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
Atezolizumab
2016
Completed Phase 3
~6040
Paclitaxel
2011
Completed Phase 4
~5380
Pertuzumab
2014
Completed Phase 3
~7500
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,493 Total Patients Enrolled
15 Trials studying Breast Cancer
4,082 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,664 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~0 spots leftby Jun 2024