A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT05132582
Trial Phases:	Phase III	Protocol IDs:	SGNTUC-028 (primary) NCI-2022-00541
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Seagen Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05132582

Summary

This study is being done to see if tucatinib works better than placebo when given with
other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill
that looks the same as tucatinib but has no medicine in it. This study will also test
what side effects happen when participants take this combination of drugs. A side effect
is anything a drug does to the body besides treating your disease.

Participants will have cancer that has spread in the body near where it started (locally
advanced) and cannot be removed (unresectable) or has spread through the body
(metastatic).

In this study, all participants will get either tucatinib or placebo. Participants will
be assigned randomly to a group. This is a blinded study, so patients and their doctors
will not know which group a participant is in.

All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to
treat this type of cancer.

Objectives

Control arm: Placebo given orally twice daily plus trastuzumab and pertuzumab every 21
days

Experimental arm: Tucatinib 300 mg given orally twice daily plus trastuzumab and
pertuzumab every 21 days

Trastuzumab and pertuzumab will be administered as follows:

• Trastuzumab will be given intravenously (IV) at a dose of 6 mg/kg or subcutaneously
(SC) at a fixed dose of 600 mg, once every 21 days.

AND

- Pertuzumab will be given IV at 420 mg every 21 days. OR

- Fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units
hyaluronidase will be given SC, once every 21 days, in lieu of trastuzumab and
pertuzumab individually.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**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.