Update: FDA approves new treatment for metastatic triple-negative breast cancer
Summary
The FDA approved the use of sacituzumab govitecan-hizy (Trodelvy), a treatment drug for people with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. (4/27/20)
Relevance
This article is most relevant for People with metastatic triple-negative breast cancer who have received at least two prior lines of treatment
Relevance: High
Research Timeline: Post Approval
Contents
| At a glance | Guidelines |
| Findings | Questions for your doctor |
| Clinical trials | Resources |
APPROVAL AT A GLANCE
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.
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Reference:
Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments. Website. April, 2020.
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 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
National Comprehensive Cancer Network (NCCN) guidelines for treatment of advanced or TNBC includes the following:
- Genetic testing:
- All people diagnosed with at any age meet guidelines for genetic counseling and testing.
The NCCN lists the following as preferred treatments for TNBC:
- therapy:
- For people with an inherited or mutation: (Lynparza) or ().
- For people without an inherited or mutation: chemotherapy.
- Second-line therapy:
- For people with but who test HER2-low: fam-trastuzumab deruxtecan-nxki (Enhertu).
- For people with who are not HER2-low: sacituzumab govitecan (Trodelvy) or chemotherapy.
- Third -ine or higher therapy:
- The NCCN recommends based on testing.
Updated: 02/23/2024
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
- 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
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.
- 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.
Updated: 02/23/2024
Open Clinical Trials
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.
- 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.
Updated: 02/01/2024
Peer Support
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:
Updated: 05/07/2024
Related Resources
The following organizations have resources related to breast cancer.
- FORCE related resources:
- Information: Breast cancer screening and prevention
- Information: Breast cancer treatment
- Personalized portal: Breast cancer
- XRAY category: Breast cancer
- XRAY category: breast cancer
- Video playlist: Breast cancer
- Blogs: Breast cancer
- General breast cancer resources:
- breast cancer resources:
- Male breast cancer resources:
- Resources for Black, Indigenous and People of Color:
Updated: 05/22/2024