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Guideline: FDA approves an immunotherapy treatment for some patients with triple-negative breast cancer

THIS INFORMATION HAS BEEN UPDATED: In August 2021 Roche voluntarily withdrew their FDA accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1. 

The FDA approved the use of the immunotherapy drug atezolizumab (Tecentriq) in combination with the chemotherapy agent nab-paclitaxel (Abraxane) for certain patients with advanced triple-negative breast cancer. (5/26/19)

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Contents

At a glance             Guidelines
Findings                                Questions for your doctor               
Clinical trials In-depth
Media Resources and references


STUDY AT A GLANCE

This study is about:

approval of the drug Tecentriq for treatment of some advanced triple-negative breast cancers.

THIS INFORMATION HAS BEEN UPDATED: In August 2021 Roche voluntarily withdrew their  accelerated approval for Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or triple-negative breast cancer (mTNBC) whose tumours express

Why is this study important?

On March 8, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval of atezolizumab (Tecentriq) in combination with the chemotherapy agent nab-paclitaxel (Abraxane) for advanced . Tecentriq is the first drug known as an "immune checkpoint inhibitor" approved for breast cancer.

Study findings:

Atezolizumab (Tecentriq) is a type of immunotherapy and nab-paclitaxiel (Abraxane) is a type of chemotherapy. The FDA approved the combination of these two drugs as a first line treatment for locally advanced or metastatic triple-negative breast cancer.

Tecentriq is approved for people whose breast cancers express “programmed death-ligand 1” (PD-L1), a protein that may help cancers avoid detection by the immune system. At the same time, the FDA also approved a tumor test, a called VENTANA PD-L1 (SP142). This test looks for expression of PD-L1 in cancers and is used to predict which tumors will respond to Tecentriq.

In the clinical trial, patients who received Tecentriq and Abraxane had progression free survival of 7.5 months compared to 5.5 months among patients who received Abraxane without Tecentriq.

Among patients with PD-LI-positive tumors, the median progression free survival was 7.5 months and 5.0 months respectively. Patients who had PD-L1 positive tumors and who received Tecentriq and Abraxane survived about 10 months longer than patients who did not receive Tecentriq.

As with most cancer medicines, the combination of Tecentriq and Abraxane may cause side effects.

The most common side effects were:

  • hair loss: 56.4%
  • nausea: 46%
  • cough: 24.8%
  • peripheral neuropathy (numbness or pain in the feet or hands): 47%
  • neutropenia (low white blood cell counts): 20.8%
  • fever: 18.8%
  • hypothyroidism (underactive thyroid): 13.7%

35% of the breast cancer patients treated with Tecentriq and Abraxane had severe side effects compared to 30% who had only Abraxane. Severe side effects include inflammation of the lung and liver (13%).

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What does this mean for me?

If you’ve been diagnosed with locally advanced or metastatic triple-negative breast cancer, you may want to talk to your doctor about PD-L1 testing of your breast cancer and whether the Tecentriq plus Abraxane treatment combination is right for you.

It’s important to know that Tecentriq did not work for all patients with advanced breast cancer. On average, patients who received Tecentriq had 2 ½ months longer “progression-free survival” than patients who did not receive Tecentriq. On average, patients who received Tecentriq survived 10 months longer than patients who did not receive Tecentriq. Patients who received Tecentriq were more likely to have serious side effects.

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Expert Guidelines

National Comprehensive Cancer Network (NCCN) guidelines for treatment of advanced or metastatic TNBC includes the following:

  • Genetic testing:
    • All people diagnosed with TNBC at any age meet guidelines for genetic counseling and testing. 

The NCCN lists the following as preferred treatments for metastatic TNBC:

  • therapy:
    • For people with an inherited or mutation: (Lynparza) or (). 
    • For people without an inherited BRCA1 or BRCA2 mutation: chemotherapy. 
  • Second-line therapy:
    • For people with TNBC but who test HER2-low: fam-trastuzumab deruxtecan-nxki (Enhertu).
    • For people with TNBC who are not HER2-low: sacituzumab govitecan (Trodelvy) or chemotherapy.
  • Third -ine or higher therapy: 
    • The NCCN recommends based on testing.

Updated: 02/23/2024

Questions To Ask Your Doctor

  • How do I get PD-L1 testing of my breast cancer?
  • Are there other tumor biomarker tests that may help guide my treatment?
  • Is the Tecentriq plus Abraxane combination treatment an option for my type of breast cancer?
  • What are the side effects that I might experience with the Tecentriq plus Abraxane combination treatment?
  • Are there other immunotherapy agents that may be used to treat my cancer?

Open Clinical Trials

The following are studies looking at new treatments for people with metastatic TNBC.  

Several other clinical trials for treating patients with metastatic TNBC can be found here.

Updated: 02/23/2024

Open Clinical Trials

The following studies look at treatment for people with advanced

 

Updated: 03/28/2025

Peer Support

The following organizations offer peer support services for people with or at high risk for breast cancer:

Updated: 05/07/2024