Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
This study is being done to see if tucatinib works better than placebo to help patients who
have a specific type of breast cancer called HER2 positive breast carcinoma. The breast
cancer in this study is either metastatic (spread into other parts of the body) or cannot be
removed completely with surgery. All patients in the study will get capecitabine and
trastuzumab, two drugs that are often used to treat this cancer.
Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill
with no medicine). This is a blinded study, so neither patients nor their doctors will know
whether a patient gets tucatinib or placebo.
Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills
two times every day. They will swallow capecitabine pills two times a day during the first
two weeks of each cycle. Patients will get trastuzumab injections from the study site staff
on the first day of every cycle.
View more details from ClinicalTrials.gov.
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Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.