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Guideline: FDA issues alert on a drug combination to treat triple-negative breast cancer

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Contents

At a glance Clinical trials
Why is this alert important?  Guidelines              
What is Tecentriq Questions for your doctor           
What does this mean for me? Resources


ALERT-AT-A-GLANCE

This alert is about:

A Food and Drug Administration () alert warning health care providers, researchers and patients that Tecentriq (atezolizumab) should not be combined with Taxol (paclitaxel) to treat patients with advanced ().

Abraxane is not Taxol

Abraxane and Taxol are similar chemotherapy agents.  Abraxane is a modified form of Taxol.  It has a protein bound to it to help it get into cancer cells. While similar, Abraxane and Taxol are different drugs and they may act differently when used to treat cancer.

Why is this alert important?

This alert is for patients and their doctors. It warns against combining two approved treatments for advanced . While Tecentriq and Taxol are approved to treat some types of advanced , the drugs are not approved to be used together.

What is Tecentriq?

Tecentriq is a type of known as an "immune checkpoint inhibitor." It is approved for treating people whose triple-negative breast cancer makes a known as “ (programmed death-ligand 1”. is a protein that helps cancer cells avoid detection by the immune system. The has approved the VENTANA (SP142) to see if treatment with Tecentriq would be beneficial for individual patients. This test looks for in cancer cells and is used to find tumors that are most likely to respond to Tecentriq.

Results of the IMpassion 130 and 131 clinical trials and approvals and alerts

On March 8, 2019, the U.S. Food and Drug Administration () granted accelerated approval of Tecentriq in combination with the chemotherapy agent Abraxane for advanced . This approval was the result of the IMpassion 130 trial which showed that this drug combination improved progression-free survival in patients with advanced . Learn more about the results of the IMpassion 130 trial here.

On September 8, 2020, the warned that Abraxane should not be replaced with Taxol to treat patients with advanced .  The results of the IMpassion 131 trial prompted this alert.  The trial found no benefit of Tecentriq combined with Taxol compared to Taxol alone in patients with advanced

Context:

The continually reviews data from drug trials and reports any potential changes in prescribing information. The IMpassion 131 trial results are preliminary. While trial enrollment is closed, researchers continue to gather new data on participants.  The will review these results along with data from other trials that are also looking at the use of Tecentriq combined with Taxol and recommend additional changes if appropriate.

Conclusions:

The approval of Tecentriq combined with Abraxane has not changed. This drug combination is approved for treatment of some women with advanced . The is warning patients and health care providers not to combine Tecentriq with Taxol for patients with advanced because it does not appear to benefit them. Tecentriq combined with Taxol is approved for other cancers. Patients taking Tecentriq combined with Taxol for other approved indications should continue as directed.

What does this mean for me?

Tecentriq is the first immune checkpoint inhibitor drug approved for breast cancer. If you have been diagnosed with locally advanced or triple-negative breast cancer, you may want to talk to your doctor about tumor testing and whether the Tecentriq plus Abraxane treatment combination is right for you.

Talk to your health care provider if you have any concerns or questions about your breast cancer treatment. If you have any adverse events or side effects related to treatment with Tecentriq in combination with Abraxane, consider completing the ’s MedWatch Online Voluntary Reporting form.

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Posted 09/17/20
 

Reference

issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer
 

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

This article is relevant for:

People with metastatic triple-negative breast cancer

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Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network (NCCN) has guidelines for treatment of TNBC, which includes the following. 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:

  • therapy:
    • For people with an inherited or mutation, the guidelines recommend  (Lynparza) or (). 
    • For people without an inherited or mutation, the guidelines recommend chemotherapy. 
  • Second-line therapy:
    • For people with but who test HER2-low, the guidelines recommend Fam-trastuzumab deruxtecan-nxki (Enhertu).
    • For people with who are not HER2-low, the guidelines recommend Sacituzumab govitecan (Trodelvy) or chemotherapy.
  • Third line or higher: 
    • NCCN recommends based on testing. 

Updated: 02/23/2024

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Does this alert affect my treatment?
  • How can I have my breast cancer tested for ?
  • Are other tumor tests available to help guide my treatment?
  • Is the Tecentriq plus Abraxane combination treatment an option for my breast cancer?
  • What side effects may I experience with 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: 02/23/2024

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