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

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

Tecentriq is approved for people whose breast cancers express “programmed death-ligand 1” (), a protein that may help cancers avoid detection by the immune system. At the same time, the also approved a tumor test, a called VENTANA (SP142). This test looks for expression of 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 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 triple-negative breast cancer, you may want to talk to your doctor about 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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This article is relevant for:

People with metastatic, triple-negative breast cancer

This article is also relevant for:

Men with breast cancer

Triple negative breast cancer

People with a genetic mutation linked to cancer risk

Breast cancer survivors

Women under 45

Women over 45

Metastatic cancer

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IN-DEPTH REVIEW OF RESEARCH

Study background:

() accounts for approximately 15–20% of all breast cancers. is associated with earlier age of onset, aggressive clinical treatments, and a poorer prognosis compared to hormone receptor- and breast cancers. Given the lack of effective treatments for , researchers have focused on increasing the therapeutic options for patients.

The immune system has a key influences on the course of . Clinical trials have sought to better understand and define the role of immune checkpoint inhibitors as a treatment for . (Immune system checkpoint inhibitors are drugs that prevent malignant cells from evading the immune system). The culmination of these studies was the phase III IMpassion 130 trial. The iMpassion 130 trial showed an overall survival benefit in patients with advanced who were treated with the immune checkpoint inhibitor atezolizumab in combination with chemotherapy compared to chemotherapy alone.

This XRAYS review provides an update on research that we first covered in 2017.

Researchers of this study wanted to know:

Whether the combination of the inhibitor atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) compared to nab-paclitaxel alone increased progression-free survival in patients with locally advanced or TNBC. Progression-free survival is the period when a cancer doesn’t grow.

Population(s) looked at in the study:

Patients with untreated TNBC who participated in the IMpassion130 trial were randomly assigned to receive atezolizumab plus nab-paclitaxel (451 patients) or plus nab-paclitaxel (452 patients).  Patients continued their treatment regimens until their disease progressed or an unacceptable level of side effects occurred. Median follow-up  timewas 12.9 months.

Researchers looked at the data from patients by the following groupings:

  • whether they did or did not receive or nab-paclitaxel therapy
  • the presence or absence of liver metastases at the beginning of the clinical trial.
  • whether or not their tumor expressed programmed death ligand 1 () protein at the beginning of the clinical trial.

The two primary trial goals were to determine progression-free survival (the time before tumors grew) in the population treated with atezolizumab and PD-L1-positive subgroup, and overall survival (the time before death) in the population treated with atezolizumab. If the findings related to overall survival were significant, they would then look at the impact of this treatment on the overall survival in the PD-L1-positive subgroup.

Study findings: 

Patients who received the combination therapy showed a clinically meaningful median PFS of 7.2 months compared to 5.5 months with chemotherapy alone. One-year progression-free survival rates were 29% and 16% respectively. Among patients with PD-LI-positive tumors, median progression-free survival was 7.5 months and 5.0 months respectively.

Median overall survival was 21.3 months with combination therapy and 17.6 months with nab-paclitaxel alone. A positive overall survival outcome was achieved only in PD-L1-positve patients. In these patients, median overall survival was 25.0 months compared to 15.5 months for patients with PD-L1-negative tumors.

Almost 16% of patients who received the combination therapy had to stop treatment due to adverse effects, compared to 8.2% of those receiving nab-paclitaxel alone.

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Limitations:

The results of IMpassion130 offer hope for as effective treatment of TNBC. However, researchers raised a number of questions including which tumors should be tested for expression, whether nab-paclitaxel is the best chemotherapy to be used with atezolizumab, and whether atezolizumab alone may be best for some patients.

Conclusions:

Treatment with atezolizumab plus nab-paclitaxel increased progression-free survival in patients with TNBC whose tumors were PD-L1-positive. 

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Posted 5/26/19

Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network (NCCN) brings together national expert panels that create guidelines for cancer treatment. The guidelines for advanced or TNBC includes the following:

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

NCCN lists the following as preferred treatments for TNBC:

  • Chemotherapy:
    • NCCN lists several different chemotherapy combinations.
    • NCCN lists Sacituzumab govitecan-hziy (Troveldi) for treatment in people who have received at least two prior lines of treatment, with at least one treatment line for breast cancer. 
  • Targeted therapy:
    • NCCN lists Olaparib (Lynparza) or () for people with an inherited or mutation. 
  • Immunotherapy: 
    • NCCN lists Pembrolizumab as a preferred therapy for people with tumors that test positive for expression. 

Updated: 12/04/2021

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • How do I get testing of my breast cancer?
  • Are there other tumor 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 agents that may be used to treat my cancer?

Open Clinical Trials
Open Clinical Trials

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

A number of other clinical trials for treating patients with TNBC can be found here.

Updated: 12/04/2021

Open Clinical Trials
Open Clinical Trials

The following are studies looking at treatment for people with advanced

Updated: 08/23/2022

Peer Support
Peer Support

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

Updated: 11/29/2022

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