Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer

Summary

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.

Conditions

• Metastatic Breast Adenocarcinoma
• Metastatic HER2-Positive Breast Carcinoma
• Recurrent Breast Adenocarcinoma
• Recurrent HER2-Positive Breast Carcinoma
• Stage III Breast Cancer AJCC v7
• Stage IV Breast Cancer AJCC v6 and v7
• Unresectable Breast Carcinoma
• Unresectable HER2-Positive Breast Carcinoma

Interventions

DRUG

Atezolizumab

Given IV

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Docetaxel

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Pertuzumab

Given IV

OTHER

Placebo Administration

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

BIOLOGICAL

Trastuzumab

Given IV

Sponsors & Collaborators

• NRG Oncology

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Charles E Geyer · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-05

Primary Completion

2024-04-30

Completion

2025-04-04

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations