Atezolizumab + Chemotherapy for HER2-Positive Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a single arm, Phase IIA clinical trial assessing the safety and efficacy of atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab in 50 patients with locally advanced, unresectable, or metastatic HER2-overexpressing breast cancer. Due to concerns that corticosteroids may have a negative effect on tumor immunity expected with addition of atezolizumab to the standard of care regimen, patients will receive premedication with dexamethasone only for weeks 1 and 2 of the weekly paclitaxel, and then corticosteroid premedication will be discontinued subsequently.Patients must have pathologically confirmed HER2-overexpressing breast cancer that is locally recurrent, unresectable, or metastatic, with measurable disease as defined by RECIST v1.1. Tumor measurements and bone scans will be performed every 9 weeks while patients are on study.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including systemic corticosteroids, immunosuppressive medications, and herbal medications. If you are using a RANKL inhibitor like denosumab, it must be discontinued during the study. Bisphosphonate therapy is allowed.
Is the combination of Atezolizumab and chemotherapy safe for HER2-positive breast cancer?
The combination of Atezolizumab with chemotherapy and other HER2-targeted therapies like trastuzumab and pertuzumab has been studied for safety in breast cancer. While there is some concern about cardiac safety with these treatments, studies suggest they can generally be administered safely, though caution is advised, especially when combined with radiation.12345
What makes the drug combination of Atezolizumab, Paclitaxel, Pertuzumab, and Trastuzumab unique for HER2-positive breast cancer?
What data supports the effectiveness of the drug combination Atezolizumab, Tecentriq, Paclitaxel, Taxol, Onxol, Abraxane, Paclitaxel, Pertuzumab, Perjeta, Trastuzumab, Herceptin, Trazimera, Herzuma, Ontruzant for HER2-Positive Breast Cancer?
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Paclitaxel
- Pertuzumab
- Trastuzumab
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fox Chase Cancer Center
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD