FDA approves an immunotherapy treatment for some patients with triple-negative breast cancer
Full article: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-atezolizumab-pd-l1-positive-unresectable-locally-advanced-or-metastatic-triple-negative
THIS INFORMATION HAS BEEN UPDATED: In August 2021 Roche voluntarily withdrew their FDA accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1.
The FDA approved the use of the immunotherapy drug atezolizumab (Tecentriq) in combination with the chemotherapy agent nab-paclitaxel (Abraxane) for certain patients with advanced triple-negative breast cancer. (5/26/19)
Questions To Ask Your Health Care Provider
- How do I get PD-L1 testing of my breast cancer?
- Are there other tumor biomarker tests that may help guide my treatment?
- Is the Tecentriq plus Abraxane combination treatment an option for my type of breast cancer?
- What are the side effects that I might experience with the Tecentriq plus Abraxane combination treatment?
- Are there other immunotherapy agents that may be used 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 will look at 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 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.
- NCT04020575: Using a Type of Immunotherapy Called CAR-T to Treat Metastatic 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 metastatic breast cancer.
- NCT03971409: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent TNBC (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 metastatic TNBC that has recurred.
- NCT04491942: Testing a Targeted Therapy in Combination with Chemotherapy for Advanced Solid Tumors. This study looks at how well a new drug called elimusertib works when combined with chemotherapy for treating people with metastatic triple-negative breast cancer and other advanced cancers.
- 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 (RT) is safe and effective in 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 is looking at the safety, side effects, and best dose of a drug called CF33-hNIS-antiPDL1 in treating patients with metastatic 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 metastatic TNBC can be found here.
The following studies are looking 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 will test 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.
- NCT05169437: PARP inhibitor (niraparib) in patients with inherited or tumor PALB2 mutations in advanced solid tumors (PAVO). PAVO is a Phase II study investigating if the PARP inhibitor niraparib is safe and effective for people with an advanced solid tumor who have an inherited PALB2 gene mutation or a tumor with a PALB2 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 BRCA1, BRCA2, ATM, RAD51C, RAD51D, 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 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 will look 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 will look 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.
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.