Clinical Trial TitleA study of tucatinib vs. placebo in combination with ado-trastuzumab emtansine (T-DM1) for patients with advanced or metastatic HER2+ breast cancer.
National Clinical Trial Number:NCT03975647
Clinical Trial Protocol Description:
The purpose of this study is to investigate a drug called tucatinib plus another drug called T-DM1 to find out what the side effects are and if the combination works for treating HER2 positive breast cancer. We don’t yet know if tucatinib plus T-DM1 is better or worse than other treatments. Learning about the side effects of tucatinib plus T DM1 and how it works will help us understand if tucatinib plus T-DM1 is better or worse than other treatments.
This study uses an investigational drug. An “investigational drug” means that the U.S. Food and Drug Administration (FDA) hasn’t approved it for sale in the United States and it must be tested to see if it is a safe and effective treatment method. The investigational drug in this study is called tucatinib. This study also uses another drug called ado-trastuzumab emtansine (T-DM1). The brand name for T-DM1 is KADCYLA®. T-DM1 has already been approved by the FDA for treatment of HER2+ breast cancer.
Study participation may last up to 5 years and participants will be asked to come to the clinic for study visits 2-3 times per month while they are receiving treatment. They will be contacted by phone or asked to come to the clinic every 9 weeks or so until the study closes.
More information can be found on the website clinicaltrials.gov by searching for NCT03975647.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age at enrollment.
- Have histologically confirmed HER2+ metastatic breast carcinoma.
- Have a history of prior treatment with a taxane and trastuzumab in any setting, separately or in combination.
- Have progression of unresectable locally-advanced or metastatic breast cancer after last systemic therapy, or be intolerant of last systemic therapy.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior treatment with T-DM1, tucatinib, neratinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior treatment with lapatinib within 12 months of starting study treatment.
- Have had treatment with any systemic anti-cancer therapy (including hormonal therapy), non-CNS radiation, experimental agent or participation in another interventional clinical trial ≤3 weeks prior to first dose of study treatment.
This is a partial list of elgibility requirements.