Study: Trodelvy clinical trial results likely practice-changing for people with metastatic triple-negative breast cancer
|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|
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 metastatic 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.
Metastatic 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 (FDA) granted accelerated approval of the drug Trodelvy for the treatment of advanced, triple-negative breast cancer 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 metastatic breast cancer (TNBC).
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 FDA 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 randomized study. The FDA 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 FDA approval of Trodelvy was first reviewed here.
The early phase (I/II) IMMU-132 study included 108 patients with metastatic 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.
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 metastatic breast cancer (TNBC).
Identical to the IMMU-132 study, participants in the ASCENT study were randomized to receive either Trodelvy or their doctor’s choice of chemotherapy.
The ASCENT study included 468 patients with metastatic TNBC. It did not include TNBC 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).
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:
- neutropenia (abnormally low levels of white blood cells)
- hair loss
- decreased appetite
- 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 TNBC 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.
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 TNBC. These important results will likely change how patients living with metastatic TNBC are treated.
If you have been diagnosed with locally advanced or metastatic triple-negative breast cancer, you may want to talk to your doctor about Trodelvy.
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This article is relevant for:
People with metastatic triple-negative breast cancer
This article is also relevant for:
Triple negative breast cancer
Women over 45
Women under 45
Be part of XRAY:
- 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?
- NCT0399213: A Study to Evaluate Rucaparib in Combination with Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR). This study will look at how safe, effective and tolerable the oral PARP inhibitor Rucaparib is when used in combination with either lucitanib or Trodelvy in patients with a solid tumor.
- NCT03901339. Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02): This study is looking at how safe and effective Trodelvy is compared to physician’s choice of chemotherapy in patients with metastatic or locally recurrent ER/PR-positive, Her2-negative metastatic breast cancer, after at least 2, and no more than 4, prior chemotherapy regimens.
- NCT0444888: Sacituzumab Govitecan +/- Pembrolizumab in HR+ / HER2 – MBC. This is looking at how safe and effective Trodevly with or without Pembrolizumab is in patients with metastatic ER/PR-positive, Her2-negative breast cancer.
- NCT04468061: Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC). This early phase study is looking at how safe and effective Trodelvy with or without Pembrolizumab is in patients who have TNBC that has spread to other parts of the body.
Metastatic Breast Cancer Project. The goal of the project is to learn more about the experiences and outcomes of people with metastatic breast cancer through information from medical records, genomic data, and patient-reported data.
You can find additional research studies enrolling people with metastatic breast cancer through our Research Search and Enroll Tool.
Who covered this study?
Newly approved drug boosts survival in metastatic TNBC This article rates 4.5 out of 5 stars
Phase 3 ASCENT trial in metastatic TNBC meets primary end point of PFS This article rates 4.0 out of 5 stars
Immunomedics wows ESMO with breast cancer data reveal This article rates 3.5 out of 5 stars