FDA issues alert on a drug combination to treat triple-negative breast cancer
https://www.facingourrisk.org/XRAY/FDA-warns-against-tecentriq-and-paclitaxel-combo-therapy
Full article: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-issues-alert-about-efficacy-and-potential-safety-concerns-atezolizumab-combination-paclitaxel#:~:text=On%20September%208%2C%202020%2C%20the,or%20metastatic%20triple%20negative%20breast
The immunotherapy drug Tecentriq (atezolizumab) is approved for use with Abraxane (nab-paclitaxel) to treat metastatic triple-negative breast cancer. Tecentriq is NOT approved for use with Taxol (paclitaxel). The Food and Drug Administration has issued an alert to doctors, researchers and patients warning that Tecentriq should not be used in combination with Taxol to treat patients with advanced triple-negative breast cancer. (09/18/20)
Questions To Ask Your Health Care Provider
- Does this FDA alert affect my treatment?
- How can I have my breast cancer tested for PD-L1?
- Are other tumor biomarker tests available to help guide my treatment?
- Is the Tecentriq plus Abraxane combination treatment an option for my breast cancer?
- What side effects may I experience with 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.
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.