Study on TDXD and Durvalumab for HER2 Positive or Low Inflammatory Breast Cancer

Sponsor: Filipa Lynce, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05795101

Provider View

This clinical trial is testing a new combination of drugs, trastuzumab deruxtecan and durvalumab, to see if they are safe and effective in treating inflammatory breast cancer that expresses the HER2 protein.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug combination, trastuzumab deruxtecan and durvalumab, for treating inflammatory breast cancer that shows the HER2 protein. These drugs are not yet approved for this type of cancer but are approved for other uses. The study will last about 22 months and involve around 63 participants. AstraZeneca is providing the drugs and funding for this research.

Description

This is a Phase 2 study where participants with stage III HER2-positive or HER2-low inflammatory breast cancer will receive a combination of trastuzumab deruxtecan and durvalumab before any surgery. Participants will be divided into two groups based on their HER2 status. The study includes screening for eligibility, regular clinic visits, tumor biopsies, and blood tests. Participants will be involved in the study for about 22 months. The study drugs are provided by AstraZeneca, and the research is supported by them.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of invasive breast cancer.
  • All types of breast cancer are eligible.
  • Must have stage III inflammatory breast cancer diagnosed within the last 6 months.
  • Must have HER2-positive or HER2-low tumor expression.
  • Any estrogen receptor (ER) and progesterone receptor (PR) expressions are allowed but must be known.
  • Must not have received any treatment for the current breast cancer.
  • Must agree to have two tumor biopsies if safely possible.
  • Must be 18 years or older, including both men and women.
  • Must have a good performance status, meaning able to carry out daily activities.
  • Must have normal organ and bone marrow function based on specific blood tests.
  • Women of childbearing potential must agree to use effective contraception during and after the study.
  • Men must agree to use contraception during and after the study.
  • Must have a life expectancy of at least 12 weeks.
  • Must weigh more than 30 kg.
  • Must be able to understand the study and agree to participate.

Exclusion Criteria

  • Have received any prior treatment for the current inflammatory breast cancer.
  • Have had any major surgery within 4 weeks before starting the study.
  • Have allergies to the study drugs or similar medications.
  • Have uncontrolled illnesses like heart failure or infections.
  • Require chronic steroid therapy or immunosuppressive medication.
  • Have active autoimmune or inflammatory disorders, with some exceptions.
  • Have a history of lung diseases or conditions affecting the lungs.
  • Have heart conditions that affect the heart's rhythm or function.
  • Have had certain heart procedures or conditions in the last 6 months.
  • Have a history of another cancer unless treated and inactive for 5 years.
  • Have a history of blood clots in the last 3 months.
  • Have active infections like tuberculosis or hepatitis.
  • Have tested positive for HIV.
  • Have received a live vaccine within 30 days before starting the study.
  • Have any condition that might interfere with the study results or participation.
  • Are using certain medications that interact with the study drugs.
  • Are pregnant, breastfeeding, or not using effective birth control if of reproductive potential.

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