Phase 2 Study of Zanidatamab for Early Stage HER2 Positive Breast Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05035836

Provider View

This clinical trial is testing the effectiveness of a new drug, zanidatamab, in treating patients with early stage HER2 positive breast cancer. The study aims to see if the drug can help eliminate cancer cells before surgery.

Patient Parameters

Program Overview

The study is focused on evaluating how well zanidatamab works for patients with early stage HER2 positive breast cancer. Researchers want to see if the drug can lead to a complete response, meaning no cancer cells are found after treatment. They will also look at how the drug affects tumor size, its safety, and any side effects. The study will explore how zanidatamab interacts with the immune system and its potential as a standalone treatment for this type of cancer.

Description

The main goal of this study is to see if zanidatamab can effectively treat early stage HER2 positive breast cancer by achieving a complete response, where no cancer cells are detected after treatment. Researchers will also assess the drug's impact on tumor size using imaging tests like ultrasound and MRI. They will monitor the safety and side effects of zanidatamab, both alone and in combination with hormone therapies like tamoxifen or letrozole for patients with hormone receptor positive tumors. The study will explore the feasibility of using zanidatamab as a single treatment and identify any biomarkers that predict how well patients respond to the drug. Additionally, researchers will investigate changes in circulating DNA and the immune environment as potential indicators of treatment response.

Eligibility Criteria

Inclusion Criteria

  • Able to provide written consent to participate.
  • Aged 18 years or older.
  • Willing to undergo surgery if needed.
  • In good general health with an ECOG performance status of 0 or 1.
  • Tumor size between 1 cm and 3 cm, with no spread to lymph nodes or other parts of the body.
  • Diagnosed with HER2 positive breast cancer, as per specific medical guidelines.
  • Normal heart function as shown by specific heart tests.
  • Adequate blood and organ function based on lab tests.
  • Willing to use effective birth control during the study and for 12 months after treatment.
  • Negative pregnancy test before starting the study drug for those of reproductive potential.

Exclusion Criteria

  • Involved in planning or conducting the study.
  • Have another cancer that could interfere with the study.
  • Have received any treatment for the current breast cancer diagnosis.
  • Have certain heart conditions or uncontrolled illnesses.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Have uncontrolled seizures or significant heart disease.
  • Have active Hepatitis B, C, or HIV.
  • Have had major surgery recently, except for portacath placement.
  • Have a history of severe allergic reactions to similar drugs.
  • Have distant metastatic disease or certain liver, kidney, or pancreatic conditions.
  • Have had a symptomatic pulmonary embolism recently.
  • Have received a live vaccine recently, except for non-live COVID vaccines.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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