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 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.
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.
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.
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).
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 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 . These important results will likely change how patients living with TNBC are treated.
If you have been diagnosed with locally advanced or triple-negative breast cancer, you may want to talk to your doctor about Trodelvy.
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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.
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:
people with triple negative breast cancer
Be part of XRAY:
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:
- 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 (Lynparza) or () for people with an inherited or mutation.
- NCCN lists Pembrolizumab as a preferred therapy for people with tumors that test positive for expression.
- 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?
The following are studies looking at new treatments for people with TNBC.
- NCT03606967: Testing the Addition of an Individual Vaccine to Nab-Paclitaxel, Durvalumab and Tremelimumab and Chemotherapy in Patients With Triple Negative Breast Cancer. This study will look at how well the combination of chemotherapy, and when used with or without a vaccine made specifically for each patient.
- NCT04468061: Saci-IO TNBC: Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative TNBC. This early phase study is looking at how safe and effective Trodelvy with or without Pembrolizumab is in patients who have that has spread to other parts of the body.
- NCT04020575: Using a Type of Called CAR-T to Treat Triple-Negative Breast Cancer. This study will look at how safe and how well a type of treatment made from the patient's cancer works for treatment certain types of breast cancer.
- NCT03971409: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With IV or Unresectable, Recurrent (InCITe). This studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating TNBC that has recurred.
- NCT04491942: Testing a in Combination with Chemotherapy for Advanced . This study looks at how well a new drug called elimusertib works when combined with chemotherapy for treating people with triple-negative breast cancer and other advanced cancers.
- NCT04837209. Radiation, and in Triple Negative Breast Cancer (NADiR). This research study is looking to see whether the combination of Dostarlimab and plus Radiation Therapy (RT) is safe and effective in participants with triple negative breast cancer.
- NCT05081492: Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and (Pembrolizumab) for Triple-Negative Breast Cancer. This study is looking at the safety, side effects, and best dose of a drug called CF33-hNIS-antiPDL1 in treating patients with triple negative breast cancer. CF33-hNIS-antiPDL1 is a virus that is designed to attack and kill cancer cells.
A number of other clinical trials for treating patients with TNBC can be found here.
The following studies are looking at treatment for people with advanced .
- NCT05252390: NUV-868 Alone and in Combination With PARP Inhibitors in Patients With Advanced .This study will test the safety and effectiveness of the experimental drug NUV-868 alone and combined with a in people with advanced . This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.
- NCT05169437: () in patients with inherited or tumor mutations in advanced (PAVO). PAVO is a Phase II study investigating if the niraparib is safe and effective for people with an advanced solid tumor who have an inherited gene mutation or a tumor with a mutation.
- NCT02264678: Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents. This is a study of ceralasertib administered orally in combination with chemotherapy regimens and/or novel anticancer agents to patients with advanced cancer. The study is enrolling people with inherited mutations, including , , , , , and people with tumors that are HRD-positive.
- NCT04644068: Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (PETRA). This research is designed to learn whether treatment with a new , AZD5305, used alone or in combination with anti-cancer agents is safe, tolerable and has anti-cancer activity in patients with advanced . The study is open to people who have previously been treated with PARP inhibitors.
- NCT04267939: ATR Inhibitor Plus Study in Advanced and Ovarian Cancer. This study will look at how well people with advanced respond to treatment with the BAY1895344 in combination with the . This study is open to people with inherited mutations in , , and other genes. Contact the study coordinator for information about eligibility for people with mutations in other genes.
- NCT04657068: Treatment with ATR Inhibitor for Advanced or Solid Tumors. This study will look at how well a new oral known as an ATR inhibitor works on advanced or with mutations in genes that are linked to damage repair. This study is open to people who have an inherited or acquired or mutation or whose tumors are HRD-positive. This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.
The following organizations offer peer support services for people with, or at high risk for breast cancer:
- FORCE peer support:
- Our Message Boards allow people to connect with others who share their situation. Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Our Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Connect online with our Private Facebook Group.
- Join our virtual and in-person support meetings.
- Other organizations that offer breast cancer support:
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