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A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer


Active: Yes
Cancer Type: Breast Cancer NCT ID: NCT03975647
Trial Phases: Phase III Protocol IDs: SGNTUC-016 (primary)
NCI-2019-03833
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Seagen Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT03975647

Summary

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works
better than T-DM1 alone 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.

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. All patients in the study will get T-DM1, a drug
that is often used to treat this cancer.

Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills
two times every day. Patients will get T-DM1 injections from the study site staff on the
first day of every cycle.

Objectives

This study is designed to evaluate the efficacy and safety of tucatinib in combination with
T-DM1 in subjects with unresectable locally-advanced or metastatic HER2+ breast cancer who
have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab
treatment is permitted, but not required. Subjects will be randomized in a 1:1 manner to
receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.

While on study treatment, subjects will be assessed for progression every 6 weeks for the
first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions.
Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of
consent, or study closure. After completion of study treatment and after occurrence of
disease progression, subjects in both arms of the study will continue to be followed for
survival until study closure or withdrawal of consent.

Treatment Sites in Georgia

Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.