NCT03501979

Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD

A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer.

Detailed description

The purpose of this study is to evaluate a new treatment for patients with HER2+ metastatic breast cancer (MBC) with leptomeningeal disease (LMD). This is a rare and fast-growing form of cancer. Leptomeningeal disease refers to the seeding of tumor cells to the leptomeninges and dissemination in the cerebrospinal fluid. Currently, there are is no standard of care treatment for LMD. However, we think the combination therapy will be safe and well-tolerated and may also improve survival. Blood and spinal fluid samples will be collected to evaluate the effects on the body and the cancer, which will help provide greater understanding to therapy response in patients. The study has a two-stage design with the first stage including 15 subjects from up to ten institutions nationwide. If it advances to the second stage based on the number of successes, another 15 subjects will be enrolled.

Conditions

• Metastatic Breast Cancer
• Leptomeningeal Disease

Interventions

Type	Name	Description
DRUG	Tucatinib	Tucatinib study drug is given in tablet form and taken daily.
DRUG	Trastuzumab	Trastuzumab is approved by the FDA and is available commercially. Trastuzumab must be prepared and is administered intravenously.
DRUG	Capecitabine	Capecitabine is approved by the FDA and is available commercially as an oral drug.

Timeline

• Start date: 2019-02-20
• Primary completion: 2021-06-22
• Completion: 2021-06-22
• First posted: 2018-04-18
• Last updated: 2025-08-29
• Results posted: 2023-02-08

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study