FDA approves an immunotherapy treatment for some patients with triple-negative breast cancer
https://www.facingourrisk.org/XRAY/FDA-approval-triple-negative-breast-cancer-treatment
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 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 trial will study 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 recurrent metastatic TNBC.
- NCT06488378: Treating HER2-negative, Metastatic Breast Cancer with a BRCA or PALB2 Mutation Using a New Drug, Axatilimab, Combined with Olaparib. The study is looking at whether adding a new targeted therapy drug called axatilimab to treatment with the PARP inhibitor olaparib (Lynparza) will improve outcomes in people with metastatic breast cancer.
- NCT06022029: Study of a New Treatment Called ONM-501 Alone and in Combination with Immunotherapy for Triple Negative Breast Cancer, Advanced Solid Tumors and Lymphomas. This study is looking at the safety and best dose for treatment with the drug ONM-501 alone or in combination with immunotherapy for treating advanced solid tumors or lymphomas.
- NCT06841354: A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.
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.
- 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.
About FORCE
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.