A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer (NCT03975647)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of South Alabama Health Children's and Women's Hospital — Mobile, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (490 Sites)
- University of South Alabama Health Children's and Women's Hospital — Mobile, Alabama
- University of South Alabama Mitchell Cancer Institute — Mobile, Alabama
- University of South Alabama Health University Hospital — Mobile, Alabama
- Banner Gateway Medical Center — Gilbert, Arizona
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- Western Regional Medical Center, LLC — Goodyear, Arizona
- Arizona Oncology Associates, PC - HOPE. — Tucson, Arizona
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona
- UCLA Hematology/Oncology - Alhambra — Alhambra, California
- Kaiser Permanente Medical Center Lab Drawing Station — Antioch, California
- Kaiser Permanente Medical Center Lab Drawing Station — Antioch, California
- UCLA Hematology/Oncology- Beverly Hills — Beverly Hills, California
- UC Irvine Health Cancer Center - Newport — Costa Mesa, California
- City of Hope Investigational Drug Services (IDS) — Duarte, California
- City of Hope(City of Hope National Medical Center,City of Hope Medical Center) — Duarte, California
- Kaiser Permanente Medical Center (Radiology) — Dublin, California
- UCLA Hematology/Oncology - Encino — Encino, California
- Kaiser Permanente Medical Center Lab Drawing Station — Fairfield, California
- Kaiser Permanente Medical Center Lab Drawing Station — Gilroy, California
- UCLA Hematology/Oncology- Irvine — Irvine, California
- Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D. — Los Angeles, California
- Regulatory Management only: TRIO-US Central Administration — Los Angeles, California
- Ronald Reagan UCLA Medical Center — Los Angeles, California
- UCLA Hematology/Oncology — Los Angeles, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.