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Update: FDA approves new treatment for metastatic triple-negative breast cancer

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This report is about: 

Approval of the drug Trodelvy (sacituzumab govitecan-hizy) for treating  triple-negative breast cancer ().

Why is this approval important?

triple-negative breast cancer is an aggressive type of cancer with few options for treatment beyond chemotherapy. On April 22, 2020 the U.S. Food and Drug Administration () granted accelerated approval of the drug Trodelvy for the treatment of advanced, . Trodelvy approval provides a new treatment option for metastatic breast cancer patients whose cancer has not responded or progressed after two previous lines of treatment.

Research findings:

approval of Trodelvy was based on previous research, which we reported in this XRAY review. In this clinical trial of 108 patients with triple-negative breast cancer:

  • 1/3 of patients who took Trodelvy (33 percent) had their cancer shrink. Of these patients: 
    • More than half (55 percent) had no cancer growth for six months.
    • 17 percent had no cancer growth for a year or longer.

As with most cancer medicines, Trodelvy may cause side effects. The most common side effects include:

  • Nausea
  • Neutropenia (abnormally low levels of white blood cells)
  • Diarrhea
  • Fatigue
  • Anemia
  • Vomiting
  • Hair loss
  • Constipation
  • Decreased appetite
  • Rash
  • Abdominal pain

The label warns about the possibility of severe neutropenia or diarrhea. 

What does this mean for me?

If you have been diagnosed with locally advanced or  , you may want to talk to your doctor about Trodelvy.

Share your thoughts on this XRAYS article by taking our brief survey.



Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments. Website. April, 2020.



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 who have received at least two prior lines of treatment

This article is also relevant for:

people with breast cancer

men with breast cancer

people with metastatic or advanced cancer

people with a genetic mutation linked to cancer risk

people with triple negative breast cancer

Be part of XRAY:

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

Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network (NCCN) indicates that tumor testing can help determine if a person with breast cancer would benefit from .

  • For tumors that are hormone receptor-positive, , testing for PIK3CA, ATK1 or mutations is recommended to help identify patients who would benefit from a known as a PI3K inhibitor.
  • For tumors that are hormone receptor-negative, , testing for is recommended to help identify patients who might benefit from .
  • For  breast tumor types, testing for MSI-H/dMMR or other biomarkers may help identify patients who would benefit from

Updated: 01/29/2024

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Is Trodelvy a treatment option for my type of breast cancer?
  • If Trodelvy is not an option for me right now, might it be an option in the future?
  • What side effects might I experience with this treatment?
  • If I have serious side effects, will I need to stop treatment?
  • Are any other agents available 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

Open Clinical Trials
Open Clinical Trials

The following studies are looking at treatment for people with advanced


Updated: 02/01/2024

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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