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

Conditions

• HER2-positive Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• tucatinib — DRUG
  300mg given twice per day by mouth (orally)
• placebo — DRUG
  Given twice per day orally
• T-DM1 — DRUG
  3.6 mg/kg given into the vein (IV; intravenously) every 21 days

Study Details

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.

Key Dates

First listed

Jun 5, 2019

Start date

Oct 2, 2019

Status verified

Jul 2026

Primary completion

Jun 29, 2023

Completion

Mar 10, 2029

Study Design

Enrollment

466 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tucatinib + T-DM1
  Tucatinib + T-DM1
• Active Comparator: Placebo + T-DM1
  Placebo + T-DM1

Primary Outcome Measure

Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment [ Time Frame: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months) ]

Locations (321)

Find similar trials in Mobile, AL

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