Study on Sequencing Antibody Drug Conjugates in ER+/HER2 Low Metastatic Breast Cancer

Sponsor: Reshma L. Mahtani, D.O.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06263543

Provider View

This clinical trial is exploring whether the drug sacituzumab govitecan (SG) is effective for patients with metastatic hormone receptor positive (HR+)/HER2 low breast cancer who have previously been treated with trastuzumab deruxtecan (T-DXd). The study aims to determine if SG can still work well in these patients.

Patient Parameters

Program Overview

The purpose of this study is to find out if sacituzumab govitecan (SG) is effective at its approved dose and schedule for people with metastatic hormone receptor positive (HR+)/HER2 low breast cancer who have already received trastuzumab deruxtecan (T-DXd). Although SG is approved for treating metastatic HR+/HER2 negative breast cancer, this study focuses on its effectiveness in patients who have previously been treated with T-DXd.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed and dated consent to participate.
  • Willing to follow all study procedures and be available for the study duration.
  • Aged 18 years or older.
  • Have confirmed metastatic or advanced breast cancer that is HER2-low, as determined by local testing.
  • Have breast cancer that is estrogen or progesterone receptor positive.
  • Cancer must be resistant to hormone therapy, as judged by the investigator, and may have had previous hormone treatments.
  • Must have received a CDK4/6 inhibitor, either alone or with hormone therapy.
  • Must have had 1 to 4 prior chemotherapy treatments for metastatic cancer.
  • Previously treated with T-DXd, which was stopped due to progression or intolerance.
  • Disease must have progressed after the most recent therapy, unless the last therapy was T-DXd stopped due to toxicity.
  • Must have measurable disease according to specific criteria.
  • Must have a performance status score of 2 or less, indicating ability to carry out light work.
  • Must have adequate organ and bone marrow function based on recent tests.
  • Must have a sufficient washout period from previous treatments before starting the study.
  • Must be post-menopausal or have a negative pregnancy test if of childbearing potential.
  • Must agree to use effective contraception if of childbearing potential and sexually active.

Exclusion Criteria

  • Have locally advanced breast cancer that can be treated with curative intent.
  • Have brain metastases, unless they are treated, asymptomatic, and stable without ongoing steroid treatment.
  • Have an active serious infection requiring antibiotics.
  • Have a history of severe allergic reaction to irinotecan.
  • Are pregnant or breastfeeding.
  • Have been treated with another investigational drug within the last 21 days.
  • Have other medical or psychiatric conditions that could interfere with the study or its interpretation.
  • Have any other condition that may increase risk, as determined by the investigator.

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