FDA approves tucatinib (Tukysa) for metastatic Her2-positive breast cancer
https://www.facingourrisk.org/XRAY/fda-approval-tucatinib-metastatic-her2-positive-breast-cancer
Full article: https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-drug-under-international-collaboration-treatment-option-patients-her2
The FDA has approved the use of tucatinib (Tukysa) in combination with chemotherapy as a treatment for people with metastatic Her2-positive breast cancer. This approval includes treatment of people whose breast cancer has spread to the brain. (4/29/20)
Questions To Ask Your Health Care Provider
- Is Tuksya a treatment option for my type of breast cancer?
- If Tukysa 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 treatment for people with metastatic HER2-positive breast cancer.
- NCT05458674: Tucatinib+Trastuzumab+Eribulin in HER2+ MBC. This study will evaluate the safety and efficacy of the three-drug combination of tucatinib, trastuzumab, and eribulin in patients with unresectable metastatic HER2-positive breast cancer after prior treatment with a taxane, trastuzumab, and T-DM1.
- NCT06100874: A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN). This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer.
- NCT03368729: Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer. This study will evaluate niraparib, a type of targeted therapy known as a PARP inhibitor. Niraparib will be combined with trastuzumab, an anti-HER2 agent, to evaluate the safety and tolerability in patients with metastatic HER2 positive breast cancer.
- NCT06435429: A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer. The efficacy and safety of zanidatamab in combination with chemotherapy compared with trastuzumab (Herceptin) in combination with chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
- NCT05378464: Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer. This study will test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.
- NCT05894239: A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer. This study will look at the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
Other clinical trials for people with breast cancer 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.