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

Active:	No
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 participants 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. Participants 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, participants 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, participants 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.