FDA approves new treatment for metastatic triple-negative breast cancer

Questions To Ask Your Health Care Provider

• 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 metastatic TNBC.  

• NCT03606967: Testing the Addition of an Individual Vaccine to Nab-Paclitaxel, Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer. This study evaluates how well the combination of chemotherapy, immunotherapy and targeted therapy when used with or without a vaccine made specifically for each patient.  
• NCT04468061: Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic TNBC. This early phase study looks at the safety and effectiveness of Trodelvy with or without pembrolizumab for patients with TNBC that has spread to other parts of the body.
• NCT04020575: Using a Type of Immunotherapy Called CAR-T to Treat Metastatic Triple-Negative Breast Cancer. This study measures the safety and effectiveness of a treatment made from the patient's cancer when used for certain types of metastatic breast cancer. 
• NCT03971409: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent TNBC (InCITe). This project studies how well the combination of avelumab with liposomal doxorubicin works with or without binimetinib. It also studies the combination of avelumab with sacituzumab govitecan to treat metastatic TNBC that has recurred.
• NCT04837209. Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer (NADiR). This research study is looking to see whether the combination of dostarlimab and niraparib plus radiation therapy is safe and effective for participants with metastatic triple-negative breast cancer.
• NCT05081492: Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer. This study identifies the safety, side effects, and best dose of a drug called CF33-hNIS-antiPDL1 (a virus that is designed to attack and kill cancer cells) for treating patients with metastatic triple negative breast cancer.

Several other clinical trials for treating patients with metastatic TNBC can be found here.

The following studies look at treatment for people with advanced solid tumors. 

• NCT05252390: NUV-868 Alone and in Combination With PARP Inhibitors in Patients With Advanced Solid Tumors.This study tests the safety and effectiveness of the experimental drug NUV-868 alone and combined with a PARP inhibitor in people with advanced solid tumors. 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 orally administered ceralasertib combined with chemotherapy regimens and/or novel anticancer agents for patients with advanced cancer. The study enrolls people with tumors that are HRD-positive or who have inherited mutations in BRCA1, BRCA2, ATM, RAD51C or RAD51D.  
• 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 PARP inhibitor, AZD5305, used alone or in combination with anti-cancer agents is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors. The study is open to people who have previously been treated with PARP inhibitors.  
• NCT04267939: ATR Inhibitor Plus Niraparib Study in Advanced Solid Tumors and Ovarian Cancer. This study looks at how well people with advanced solid tumors respond to treatment with the targeted therapy BAY1895344 in combination with the PARP inhibitor niraparib. This study is open to people with inherited mutations in ATM, BRCA1, BRCA2 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 Metastatic Solid Tumors. This study looks at how well a new oral targeted therapy known as an ATR inhibitor works on advanced or metastatic solid tumors with mutations in genes that are linked to DNA damage repair. This study is open to people who have an inherited or acquired BRCA or ATM mutation or whose tumors are HRD-positive. This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.