Atezolizumab + Standard Therapy for HER2-Positive Breast Cancer

Recruiting at 739 trial locations

Overseen By Leon C. Hwang

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies 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). Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells. \*NOTE: This study has a central confirmation step. The purpose of this step is to confirm by central testing that the patient's tumor has specific receptors. If the patient meets all the study requirements, the patient will join the study and begin therapy for breast cancer while the tumor is being tested.

Research Team

Charles E Geyer

Principal Investigator

NRG Oncology

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or can carry out light work.

My blood clotting tests are within the required range.

Patients must agree to use adequate contraception

Exclusion Criteria

I do not have brain metastases that meet exclusion criteria.

I have a history of specific health conditions related to cancer, heart, nervous system, allergies, skin, immune system, infections, or have had a transplant.

I have health issues that could make treatment risky or affect test results.

Treatment Details

Interventions

• Atezolizumab (Monoclonal Antibodies)
• Paclitaxel (Chemotherapy)
• Pertuzumab (Monoclonal Antibodies)
• Trastuzumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Arm I (pertuzumab, trastuzumab, taxane therapy, atezolizumab) Experimental Treatment 10 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 Control 10 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+