Study on Durvalumab with Trastuzumab and Pertuzumab for HER2-Enriched Breast Cancer

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03820141

Provider View

This clinical trial is testing the safety and effectiveness of combining durvalumab with trastuzumab and pertuzumab to treat patients with HER2-enriched breast cancer. These drugs aim to boost the immune system's ability to fight cancer cells.

Patient Parameters

Program Overview

The study aims to evaluate if using durvalumab along with trastuzumab and pertuzumab is safe and effective for patients with HER2-enriched breast cancer. Typically, trastuzumab and pertuzumab are used before surgery to target HER2, a protein that promotes cancer growth. These drugs can help the immune system attack cancer cells. Durvalumab is another drug that activates the immune system. By combining these treatments, researchers hope to enhance the immune system's ability to destroy cancer cells.

Description

This research study is exploring a new treatment approach for HER2-enriched breast cancer by combining three drugs: durvalumab, trastuzumab, and pertuzumab. Trastuzumab and pertuzumab are standard treatments that target the HER2 protein, which is often found in high levels in this type of breast cancer. These drugs help the body's immune system recognize and attack cancer cells. Durvalumab is an additional drug that further stimulates the immune system. The study is investigating whether adding durvalumab to the standard treatment can improve the body's ability to fight cancer. Participants will receive these medications before surgery to see if the combination is safe and effective in reducing cancer.

Eligibility Criteria

Inclusion Criteria

  • Women aged over 18 years.
  • Diagnosed with HER2-enriched and HER2-amplified breast cancer.
  • Cancer is negative for estrogen and progesterone receptors.
  • Primary tumor larger than 1 cm.
  • Any lymph node status is acceptable.
  • Can have cancer in both breasts if each meets the criteria.
  • Good overall health with a performance status of 0 or 1.
  • Healthy organ and bone marrow function.
  • Heart function must be at least 50%.
  • Postmenopausal or negative pregnancy test for premenopausal women.
  • Willing to provide biopsy samples.
  • Able to follow study procedures and attend all visits.

Exclusion Criteria

  • Participating in another clinical trial with a new drug within the last 28 days.
  • Enrolled in another clinical study unless it's non-interventional.
  • Unresolved side effects from a previous experimental drug.
  • Receiving other cancer treatments like chemotherapy or radiation.
  • Major surgery within the last 28 days.
  • History of organ transplant.
  • Autoimmune or inflammatory disorders.
  • Primary immune system deficiencies.
  • Active infections like tuberculosis, hepatitis, or HIV.
  • Use of immunosuppressive drugs within the last 14 days.
  • Received a live vaccine within the last 30 days.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Allergic to any study drugs.
  • Heart conditions affecting the QT interval or recent heart interventions.
  • Heart function less than 50%.

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