Study on Post-Surgery T-DM1 Treatment for HER2-Positive Salivary Gland Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04620187

Provider View

This clinical trial is exploring the safety and effectiveness of using the drug T-DM1, along with standard chemotherapy and radiation, to treat HER2-positive salivary gland cancer after surgery. The study also looks at how well T-DM1 works in preventing cancer from coming back.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug T-DM1, when used with chemotherapy and radiation after surgery, is safe and effective for treating HER2-positive salivary gland cancer. T-DM1 is a targeted therapy that combines a HER2 antibody with a chemotherapy drug, aiming to kill cancer cells more precisely. Although T-DM1 is not yet approved for salivary gland cancer, it is approved for certain breast cancers. The study involves treatment for up to a year after surgery and follow-up for three years, with about 55 participants expected to join.

Description

This study is a Phase II trial that is open to participants and involves multiple research centers. It focuses on using T-DM1, a drug that targets the HER2 protein found in some salivary gland cancers, in combination with chemotherapy and radiation after surgery. The study will also test the use of T-DM1 alone for up to a year to see if it helps prevent cancer from returning.

T-DM1 works by attaching to the HER2 protein on cancer cells and delivering a chemotherapy drug directly to them, which may help kill the cancer cells more effectively. The study will evaluate the safety, effectiveness, and any side effects of this treatment approach.

Participants will undergo screening to determine eligibility and will receive the study treatment, which includes regular evaluations and follow-up visits. The study is supported by Genentech, which provides the T-DM1 drug for research purposes.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of resectable stage II (with positive margins), III, IVA, or IVB salivary gland cancer, as per 2017 AJCC guidelines.
  • Willing to provide tissue samples from a biopsy or surgery, and blood samples before, during, and after treatment.
  • Cancer must be HER2-positive, determined by specific tests.
  • Must be 18 years or older.
  • Must have a performance status score of 1 or less, indicating good overall health.
  • Must have normal organ and bone marrow function based on specific blood tests.
  • Must have normal levels of calcium, magnesium, and potassium.
  • Must have a heart function test showing a left ventricular ejection fraction of 50% or higher.
  • Must be able to understand and sign a consent form.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception.
  • Men must agree to use effective contraception if sexually active with women of childbearing potential.

Exclusion Criteria

  • Cannot have stage I or stage IVC (metastatic) salivary gland cancer, or cancer that cannot be surgically removed.
  • Cannot have had previous radiation or chemotherapy for head and neck cancer.
  • Cannot have received any prior HER2-targeted therapy.
  • Cannot have an active or uncontrolled infection.
  • Cannot be pregnant or breastfeeding.
  • Cannot have uncontrolled health issues like heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that would affect participation.
  • Cannot have another active cancer that requires treatment, except for certain skin cancers or low-risk prostate cancer under surveillance. A history of another cancer in remission for at least two years is allowed.

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