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Study: Trodelvy clinical trial results likely practice-changing for people with metastatic triple-negative breast cancer

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Contents

At a glance Clinical trials
Why the ASCENT study is important Guidelines              
Study findings Questions for your doctor 
What does this study mean for me? Resources and reference

 

STUDY AT A GLANCE

This study is about:

The ASCENT study, which was done to confirm results of a prior study, IMMU-132. The early-phase IMMU-132 study showed that the drug Trodelvy improved outcomes for patients living with triple-negative breast cancer.


Trodelvy is a “smart drug”

Smart drugs combine two molecules. Trodelvy is a combination of a chemotherapy drug and an antibody that delivers it specifically to cancer cells. The chemotherapy drug then kills the cancer cells, sparing normal cells.


Why is this study important?

triple-negative breast cancer is aggressive. Patients have 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, based on results of the IMMU-132 study reviewed here. The ASCENT study was conducted to verify results of IMMU-132. It confirmed that Trodelvy benefits patients with triple-negative breast cancer ().
 

Why are confirmatory clinical trials important?

Confirming studies are done to show how well a new treatment works after it is shown in early studies to be beneficial for patients. New drugs, such as Trodelvy, that are given accelerated approval are required to be tested in a follow-up, larger clinical trial. This is done to verify that the drug really works when it is tested on many more people in a study. The may remove a drug from the market if a confirmatory study shows that the drug does not benefit patients.

The promising research that resulted in the approval of Trodelvy was first reviewed here.


Study findings:

IMMU-132 study

The early phase (I/II) IMMU-132 study included 108 patients with TNBC. Of the patients who took Trodelvy:

  • 1/3 (33 percent) saw their cancers shrink.
    • More than half (55 percent) had no cancer growth for six months.
    • 17 percent had no cancer growth for a year or longer.

ASCENT study

The phase III ASCENT study was done to measure how well Trodelvy works after it was shown in the IMMU-132 study found that it might benefit patients with triple-negative breast cancer ().

Identical to the IMMU-132 study, participants in the ASCENT study were to receive either Trodelvy or their doctor’s choice of chemotherapy.

The ASCENT study included 468 patients with TNBC. It did not include patients with brain metastases.

  • 235 patients received Trodelvy.
  • 233 patients received their doctor’s choice chemotherapy.

On average, patients who took Trodelvy in the ASCENT study:

  • had no cancer growth for 4 months longer than those who received chemotherapy (5.6 months compared to 1.7 months).
  • lived about 6 months longer than those who received chemotherapy (12 months compared to 6 months).


Side effects

As with most cancer medicines, Trodelvy may cause side effects. The side effects of Trodelvy in the ASCENT study were like the reported side effects from the IMMU-132 study. No new side effects were observed in the ASCENT study. 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

FDA-required labeling for Trodelvy warns about the possibility of severe neutropenia or diarrhea.


Strengths and limitations:

Results of the ASCENT study confirmed the earlier results of the IMMU-132 study and showed that the smart drug Trodelvy is beneficial for patients living with metastatic breast cancer.

The preliminary results of the ASCENT study were reported as a late-breaking presentation at the European Society of Medical Oncology (ESMO) Virtual Congress 2020. Full results will be presented at an upcoming medical conference.


Context

The results of the ASCENT study confirmed the results of the early phase IMMU-132 study.  Together and for the first time, these studies showed significant improvement in survival with the smart drug Trodelvy compared to standard treatment in patients with . These important results will likely change how patients living with TNBC are treated. 

 

What does this mean for me?

If you have been diagnosed with locally advanced or triple-negative breast cancer, you may want to talk to your doctor about Trodelvy.

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

 

Reference

Bardia A, Tolaney SM, et. al. LBA17 - ASCENT: A phase III study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients (pts) with previously treated triple-negative breast cancer (mTNBC). Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325.

 

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 before publication to assure scientific integrity.

This article is relevant for:

People with metastatic triple-negative breast cancer

This article is also relevant for:

Women over 45

People with triple negative breast cancer

Women under 45

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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

  • 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?
  • Should my tumor be tested to see which treatments my cancer may respond to?

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

Who covered this study?

MedPage Today

Newly approved drug boosts survival in metastatic TNBC This article rates 4.5 out of 5 stars

Cancer Network

Phase 3 ASCENT trial in metastatic TNBC meets primary end point of PFS This article rates 4.0 out of 5 stars

Pharmaphorum

Immunomedics wows ESMO with breast cancer data reveal This article rates 3.5 out of 5 stars

How we rated the media

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