Study on QBS72S for Treating Brain Metastases in Advanced Breast Cancer

Sponsor: Melanie Hayden Gephart

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05305365

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, QBS72S, for patients with advanced breast cancer that has spread to the brain. The study aims to see if QBS72S can help control the cancer and improve patient outcomes.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the drug QBS72S works in treating brain metastases in patients with advanced breast cancer. Researchers are looking at how the drug affects tumor response, survival rates, and safety in patients whose cancer has spread to the brain after previous treatments.

Description

The main goal of this study is to test how effective QBS72S is in shrinking brain tumors in patients with advanced breast cancer. Researchers will measure the overall response rate to see how many patients experience tumor reduction. They will also look at how long patients live without the cancer getting worse and overall survival rates. Additionally, the study will assess how long the response to the treatment lasts and monitor the safety of QBS72S in different patient groups.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a Karnofsky Performance Status (KPS) of 60 or above, indicating the ability to care for oneself with some assistance.
  • Must have advanced breast cancer that has spread to the brain after previous chemotherapy.
  • Must have at least one brain tumor that can be seen on an MRI scan.
  • Must not be taking corticosteroids or anticonvulsants, or must be on stable doses for at least 5 days before the study.
  • Must have completed a washout period from previous treatments, with specific timeframes for different therapies.
  • Must have adequate bone marrow, kidney, and liver function as determined by blood tests.
  • Must agree to use effective contraception during the study and for 7 months after.
  • Must be willing to provide informed consent and comply with study procedures.

Exclusion Criteria

  • Have another active cancer, except for certain skin cancers or carcinoma in situ.
  • Have had a severe allergic reaction to any of the study drugs.
  • Are taking or need to take certain medications that are not allowed during the study.
  • Are pregnant or breastfeeding.
  • Have medical or psychiatric conditions that could interfere with participation in the study.

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