Study on Trastuzumab Deruxtecan Alone or with Anastrozole for Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04553770

Provider View

This clinical trial is exploring how well the drug trastuzumab deruxtecan works by itself or when combined with anastrozole in treating early stage breast cancer that is HER2 low and hormone receptor positive.

Patient Parameters

Program Overview

This study is testing the effectiveness of trastuzumab deruxtecan, a drug that targets cancer cells with low levels of HER2, either alone or with anastrozole, which reduces estrogen to slow tumor growth. The goal is to see how well these treatments work in shrinking tumors in patients with early stage breast cancer that is HER2 low and hormone receptor positive.

Description

The main goal of this study is to find out which treatment option is more effective in achieving a complete response in patients with early stage HER2 low, hormone receptor positive breast cancer. The study will also look at the safety of these treatments and any changes in cancer markers after one cycle of therapy. Patients will be randomly assigned to one of two groups:

  • Group A: Patients receive trastuzumab deruxtecan through an IV every 21 days for up to 6 cycles, followed by surgery.
  • Group B: Patients receive trastuzumab deruxtecan through an IV and take anastrozole pills daily for 21 days, repeating every 21 days for up to 6 cycles, followed by surgery.

After finishing the treatment, patients will have a follow-up visit 21-28 days later to check on their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Have a breast tumor larger than 2 cm that can be surgically removed.
  • No signs of cancer spread to distant parts of the body.
  • Tumor must be HER2 low and hormone receptor positive.
  • Be in good overall health with a performance status of 0 or 1.
  • Have normal heart function and adequate blood cell counts.
  • Have normal liver and kidney function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 7 months after.
  • Men must agree to use contraception during the study and for 4 months after.
  • Must not have had major surgery or certain medications recently.
  • Must not be pregnant or breastfeeding.

Exclusion Criteria

  • Have recurrent or metastatic breast cancer.
  • Have inflammatory breast cancer.
  • Have had prior treatment for invasive cancer, except for certain conditions.
  • Have had recent major surgery.
  • Have significant heart problems or other serious health conditions.
  • Be unable to swallow pills.
  • Have a history of severe allergic reactions to similar drugs.
  • Have active infections like HIV or hepatitis.
  • Be pregnant or planning to become pregnant during the study.
  • Have a life expectancy of less than 3 months.

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