Study on TVB-2640 and Trastuzumab with Paclitaxel or Hormone Therapy for Treating HER2 Positive Metastatic Breast Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03179904

Provider View

This clinical trial is exploring a new treatment combination for patients with HER2 positive breast cancer that has spread to other parts of the body. The study aims to see if adding TVB-2640 to standard treatments like trastuzumab and paclitaxel or hormone therapy can help control the disease.

Patient Parameters

Program Overview

This study is testing a new combination of treatments for HER2 positive breast cancer that has spread. It includes TVB-2640, which may stop cancer cells from growing, trastuzumab, which targets specific cancer cell receptors, and paclitaxel, a chemotherapy drug. The study also looks at using hormone therapy to block estrogen, which can help some breast cancers grow. The goal is to see if this combination can better control the cancer.

Description

The main goal of this study is to see how well the combination of TVB-2640, paclitaxel, and trastuzumab works in patients whose HER2 positive breast cancer has not responded to previous treatments. Researchers want to know if this combination can shrink tumors or stop them from growing. They will also look at the safety of the treatment and how long it keeps the cancer from getting worse.

Patients will be divided into two groups:

  • Group A: Will receive TVB-2640, paclitaxel, and trastuzumab. This group will have regular cycles of treatment every 28 days, with scans and tests to monitor progress.
  • Group B: Will receive TVB-2640 and trastuzumab, along with hormone therapy. This group will also have treatment cycles every 28 days, with regular monitoring.

Both groups will have tests like echocardiograms and scans to check heart health and tumor size. Blood samples and biopsies will be collected to study how the treatment affects the cancer.

After finishing the study treatment, patients will have follow-up visits every six months for up to three years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have measurable HER2 positive breast cancer that has spread.
  • Have received no more than six previous chemotherapy treatments for metastatic cancer.
  • For Group A: Cancer must have progressed during or shortly after treatment with taxane and anti-HER2 therapy.
  • For Group B: Cancer must have progressed during or shortly after treatment with hormone therapy and anti-HER2 therapy.
  • Willing to provide tumor samples for research.
  • Must have good overall health and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for three months after.
  • Men must agree to use contraception during the study and for three months after.
  • Must be willing to return for follow-up visits.

Exclusion Criteria

  • History of severe heart problems or heart failure.
  • Uncontrolled high blood pressure or serious heart conditions.
  • Uncontrolled brain metastases or leptomeningeal disease.
  • Recent heart attack or severe heart arrhythmias.
  • Unable to recover from previous cancer treatments.
  • Have other serious illnesses or infections.
  • Currently taking other investigational cancer treatments.
  • Pregnant or breastfeeding women.
  • Unable to swallow pills or have digestive issues affecting drug absorption.
  • History of severe allergic reactions to trastuzumab.
  • Have had another invasive cancer within the last three years, except for certain skin or thyroid cancers.

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