16 Participants Needed

Atezolizumab + Chemotherapy for HER2-Positive Breast Cancer

LJ
Overseen ByLori J Goldstein, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

This drug combination is unique because it adds Atezolizumab, an immunotherapy drug, to the standard treatment of Pertuzumab, Trastuzumab, and chemotherapy, potentially enhancing the body's immune response against cancer cells in HER2-positive breast cancer.26789

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?

Research shows that combining pertuzumab and trastuzumab with chemotherapy improves survival in HER2-positive breast cancer. Additionally, adding atezolizumab to this combination may enhance the immune response against tumors, potentially improving patient outcomes.27101112

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

I am a woman with HER2-positive breast cancer that cannot be surgically removed or has spread.
My cancer is HER2 positive based on specific tests.
I have at least one tumor that can be measured on a CT scan.
See 8 more

Exclusion Criteria

My tumor cannot be measured or monitored with current methods.
I have active brain metastases or cancer in the lining of my brain.
Patients with known prior hypersensitivity reaction to any of the study drugs
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab

18 weeks
Weekly visits for paclitaxel administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years
Tumor measurements and bone scans every 9 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • Paclitaxel
  • Pertuzumab
  • Trastuzumab
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Investigational ArmExperimental Treatment4 Interventions

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tecentriq for:
  • Melanoma
  • Hepatocellular carcinoma
  • Small cell lung cancer
  • Non-small cell lung cancer
  • Urothelial carcinoma
🇪🇺
Approved in European Union as Tecentriq for:
  • 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

Trials
236
Recruited
39,300+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

In a phase III trial involving patients with high-risk HER2-positive early breast cancer, the addition of atezolizumab to standard treatment (pertuzumab-trastuzumab and chemotherapy) did not significantly improve the rates of pathologic complete response (pCR) compared to placebo, with pCR rates being 62.7% for placebo and 62.4% for atezolizumab in the overall population.
While the safety profile of atezolizumab was consistent with previous studies, it was associated with a higher frequency of serious adverse events, including five grade 5 adverse events, indicating a need for careful consideration of its use in combination therapies.
Atezolizumab With Neoadjuvant Anti-Human Epidermal Growth Factor Receptor 2 Therapy and Chemotherapy in Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: Primary Results of the Randomized Phase III IMpassion050 Trial.Huober, J., Barrios, CH., Niikura, N., et al.[2022]
The combination of tucatinib, trastuzumab, and capecitabine has shown significant improvements in progression-free survival (PFS) and overall survival (OS) for patients with HER2-positive breast cancer who have previously received standard treatments, including those with brain metastases.
New therapies like neratinib and margetuximab also demonstrate longer PFS compared to traditional treatments, although improvements in overall survival have not yet been established, highlighting the ongoing need for effective options in later lines of therapy.
Metastatic Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Current Treatment Standards and Future Perspectives.Dormann, C.[2022]
In a phase 3 trial involving 780 patients with HER2-positive metastatic gastric or gastro-oesophageal junction cancer, adding pertuzumab to trastuzumab and chemotherapy did not significantly improve overall survival compared to placebo, with median survival times of 17.5 months for the pertuzumab group and 14.2 months for the control group.
While serious adverse events were more common in the pertuzumab group (45%) compared to the control group (39%), no treatment-related deaths occurred in the pertuzumab group, suggesting a safety profile that warrants further investigation despite the lack of survival benefit.
Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study.Tabernero, J., Hoff, PM., Shen, L., et al.[2023]

Citations

Atezolizumab With Neoadjuvant Anti-Human Epidermal Growth Factor Receptor 2 Therapy and Chemotherapy in Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: Primary Results of the Randomized Phase III IMpassion050 Trial. [2022]
Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. [2022]
Metastatic Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Current Treatment Standards and Future Perspectives. [2022]
Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study. [2023]
HER2-positive metastatic breast cancer: a changing scenario. [2019]
Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer. [2022]
Cardiac Safety of Dual Anti-HER2 Therapy in the Neoadjuvant Setting for Treatment of HER2-Positive Breast Cancer. [2018]
Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): a phase II, open-label, multicenter, multinational cardiac safety study. [2022]
Interaction between Radiation Therapy and Targeted Therapies in HER2-Positive Breast Cancer: Literature Review, Levels of Evidence for Safety and Recommendations for Optimal Treatment Sequence. [2023]
The expanding role of pertuzumab in the treatment of HER2-positive breast cancer. [2021]
Taxane versus vinorelbine in combination with trastuzumab and pertuzumab for first-line treatment of metastatic HER2-positive breast cancer: a retrospective two-center study. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Combination of trastuzumab and taxane-containing intensified chemotherapy in first-line treatment of HER2-positive advanced gastric cancer. [2022]
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