Phase II Study of Sacituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab Deruxtecan (SATEEN)

Sponsor: Adrienne G. Waks

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06100874

Provider View

This study is testing the safety and effectiveness of combining two drugs, sacituzumab govitecan and trastuzumab, for treating HER2+ metastatic breast cancer in patients who have previously received trastuzumab deruxtecan.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective the combination of sacituzumab govitecan and trastuzumab is for patients with HER2+ metastatic breast cancer. Sacituzumab govitecan is an antibody-drug conjugate, and trastuzumab is a monoclonal antibody. The study will involve about 40 participants and includes various procedures such as blood tests, scans, and biopsies. Gilead Sciences Inc. is supporting the study by providing funding and one of the study drugs.

Description

This clinical trial is an open-label, multi-center, single-arm phase II study. It aims to test the safety and effectiveness of sacituzumab govitecan combined with trastuzumab (Herceptin, Herceptin Hylecta, or a trastuzumab biosimilar) in patients with HER2+ metastatic breast cancer. Participants may receive a biosimilar drug, which is a nearly identical version of an original drug made by a different company.

Sacituzumab govitecan is not yet approved by the FDA for HER2+ breast cancer, but it is approved for other types of breast cancer. Trastuzumab is FDA-approved for HER2+ breast cancer and can be given intravenously or as an injection under the skin.

The study involves several procedures, including eligibility screening, blood tests, CT or MRI scans, biopsies, treatment visits, and heart function tests. Approximately 40 people will participate in this study, which is supported by Gilead Sciences Inc. through funding and providing sacituzumab govitecan.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed invasive breast cancer that is either locally advanced and cannot be removed by surgery or has spread to other parts of the body.
  • Must have at least one measurable tumor that can be assessed by CT or MRI scans.
  • The cancer must be HER2+ according to specific guidelines.
  • Must have received previous treatments with taxane, trastuzumab, and T-DXd.
  • Must have stopped all chemotherapy or biologic treatments at least 14 days before starting the study treatment.
  • Must have resolved any side effects from previous treatments to a mild level, except for hair loss and mild nerve damage.
  • Can continue or start treatment with bone-strengthening medications if needed.
  • Must have completed any prior radiation therapy at least 7 days before starting the study treatment.
  • Previously treated brain metastases are allowed if certain conditions are met.
  • Must be 18 years or older and have a performance status score of 0 to 2.
  • Must have normal heart function and adequate organ and bone marrow function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use contraception if sexually active with women of childbearing potential.
  • Must be willing to undergo a research biopsy and provide tissue samples for research.
  • Must understand and agree to sign a consent form.

Exclusion Criteria

  • Previous treatment with any Trop-2 directed ADC, including sacituzumab govitecan.
  • Allergic reactions to trastuzumab, sacituzumab govitecan, or their ingredients.
  • Known genetic condition that increases risk for certain side effects.
  • Untreated or symptomatic brain metastases requiring steroids.
  • Known spread of cancer to the membranes surrounding the brain and spinal cord.
  • Major surgery within 2 weeks before starting the study treatment.
  • History of another cancer unless disease-free for at least 3 years or considered low risk for recurrence.
  • Uncontrolled illness or infection that could interfere with the study.
  • Pregnant or breastfeeding women are not eligible.

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