Pembrolizumab receives FDA approval for people with early-stage, triple-negative breast cancer
https://www.facingourrisk.org/XRAY/pembrolizumab-for-triple-negative-breast-cancer
Full article: https://www.nejm.org/doi/full/10.1056/NEJMoa1910549
The FDA approved the immunotherapy drug pembrolizumab (Keytruda) for the treatment of early-stage triple-negative breast cancer that has a high risk for recurrence. This marks the first approval for this type of drug, known as an immune checkpoint inhibitor, for the treatment of early-stage breast cancer. (posted 9/2/21)
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Questions To Ask Your Health Care Provider
- Is Keytruda a treatment option for my type of breast cancer?
- If Keytruda is not an option for me 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 drugs available to treat my cancer?
- Should my tumor be genetically tested to see if there are other treatments my cancer may respond to?
Open Clinical Trials
The following are studies enrolling people with early-stage, TNBC.
- NCT04915755: Using ctDNA Blood Test to Screen for Cancer DNA after Treatment for Early-Stage TNBC and/or an Inherited or Tumor BRCA Mutation; Followed by Study Comparing Niraparib with Placebo for People with Cancer DNA found in their Blood (ZEST).This study will enroll people with early-stage triple negative breast cancer or people with an inherited or acquired BRCA1 or BRCA2 mutation who have completed treatment (or are still in treatment with hormone therapy) for screening using a blood test known as circulating tumor DNA (ctDNA). People who test positive for ctDNA may be eligible to participate in a randomized study to receive the PARP inhibitor, niraparib or a placebo and undergo close monitoring with imaging (CT scans).
- NCT03498716: A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer. This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab (an immunotherapy) in combination with chemotherapy in patients with Stage II-III TNBC (Triple Negative Breast Cancer).
- NCT04584255: Treating Early-Stage BRCA, or PALB2-Associated Breast Cancer with a PARP Inhibitor (Niraparib) and Immunotherapy (Dostarlimab). This research study involves pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA mutations.
- NCT04674306: Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer. The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer.
- NCT03872388: Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy. This phase II trial studies how well atorvastatin works in treating patients with stages IIb-III triple negative breast cancer who did not achieve a pathologic complete response to neoadjuvant chemotherapy. Atorvastatin is used for the treatment of high cholesterol and may reduce the risk of triple negative breast cancer from coming back.
- NCT03562637: Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC. The GLORIA study is a Phase III, randomized trial looking at the use of the drug adagloxad simolenin (OBI-822) in combination with the drug OBI-821 in the adjuvant treatment of patients with high-risk early-stage TNBC.
A number of other clinical trials for patients with early-stage 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.