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 studies look at treatment for people with metastatic HER2-positive breast cancer.
- NCT05458674: Tucatinib+Trastuzumab+Eribulin in HER2+ MBC. This study evaluates 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 study evaluates 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 evaluates the safety and tolerability of the PARP inhibitor niraparib combined with anti-HER2 agent trastuzumab for 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. This study evaluates the safety and effectiveness of zanidatamab combined with chemotherapy compared to trastuzumab (Herceptin) combined with chemotherapy to treat 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 tests the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) vaccine given in combination with pepinemab added to standard-of-care therapy trastuzumab for 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 looks at the safety and effectiveness of inavolisib combined with Phesgo (pertuzumab, trastuzumab and rHuPH20 injection) compared with placebo combined with Phesgo for maintenance therapy after induction therapy for 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.