Study Comparing DB-1303/BNT323 with Chemotherapy for HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer

Sponsor: DualityBio Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06018337

Provider View

This clinical trial is testing a new drug, DB-1303/BNT323, against standard chemotherapy to see which is more effective in slowing down the progression of HER2-low, hormone receptor positive metastatic breast cancer.

Patient Parameters

Program Overview

The aim of this study is to compare the effectiveness of a new treatment, DB-1303/BNT323, with standard chemotherapy in patients with HER2-low, hormone receptor positive metastatic breast cancer. Researchers want to see which treatment helps patients live longer without their cancer getting worse.

Description

This is a Phase III study, meaning it is in the later stages of testing. It involves patients with HER2-low, hormone receptor positive metastatic breast cancer that has worsened after at least two previous treatments. The study will include about 532 participants from around the world. Participants will be randomly assigned to receive either the new drug, DB-1303/BNT323, or a chemotherapy drug chosen by their doctor (capecitabine, paclitaxel, or nab-paclitaxel). The treatment will continue until the cancer progresses, side effects become too severe, or the participant decides to stop.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Have advanced or metastatic breast cancer with HER2-low expression.
  • Cancer must be hormone receptor positive (estrogen or progesterone receptor positive).
  • Must have a tumor sample available for testing.
  • Good overall health with a performance status of 0 or 1.
  • Cancer must have worsened after specific previous treatments.
  • No prior chemotherapy for advanced or metastatic breast cancer, unless it was given more than 12 months before the cancer returned.
  • Life expectancy of at least 12 weeks.
  • Must have at least one measurable tumor or bone-only disease that can be assessed by scans.
  • Women of childbearing potential must use effective contraception during and after the study.
  • Men must use a condom with spermicide during and after the study.

Exclusion Criteria

  • Not eligible for any of the chemotherapy options in the study.
  • Have uncontrolled illnesses or conditions that could interfere with the study.
  • Have uncontrolled fluid buildup in the body that requires frequent drainage.
  • Have significant heart disease.
  • Have a history of lung disease that required steroids.
  • Have used immunosuppressive medication recently, except for certain low-dose steroids.
  • Have unresolved side effects from previous cancer treatments.
  • Have had previous anti-HER2 therapy.
  • Have had certain previous treatments with specific drugs.
  • Have participated in a previous DB-1303/BNT323 study.
  • Have substance abuse issues or other medical conditions that could interfere with the study.

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