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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Given IV
• Biopsy — PROCEDURE
  Undergo biopsy
• Bone Scan — PROCEDURE
  Undergo bone scan
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Docetaxel — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Paclitaxel — DRUG
  Given IV
• Pertuzumab — BIOLOGICAL
  Given IV
• Placebo Administration — OTHER
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Trastuzumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Apr 5, 2019

Status verified

May 2026

Primary completion

Apr 30, 2024

Completion

Apr 4, 2025

Study Design

Enrollment

190 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (pertuzumab, trastuzumab, taxane therapy, placebo)
  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 placebo IV 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 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.
• Experimental: Arm II (pertuzumab, trastuzumab, taxane therapy, atezolizumab)
  Patients receive pertuzumab, trastuzumab, and paclitaxel or docetaxel as in Arm I. 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 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.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: At the definitive analysis 2.5 years ]

Locations (662)

Related coverage on Hipa.ai

• Atezolizumab Shows Improved PFS in HER2+ Metastatic Breast Cancer
  Atezolizumab · Dec 30, 2025 · ClinicalTrials.gov
• Atezolizumab in HER2+ Metastatic Breast Cancer Shows Improved PFS
  Atezolizumab · Apr 30, 2024 · ClinicalTrials.gov

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