Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)

Launched by MERCK SHARP & DOHME LLC · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called patritumab deruxtecan for patients with a specific type of breast cancer known as HER2 positive breast cancer. This type of cancer is locally advanced, meaning it cannot be surgically removed, or it has spread to other parts of the body. The main goals of the study are to see how safe patritumab deruxtecan is and how well it works in shrinking the cancer or making it go away.

To participate in this trial, patients need to have confirmed HER2 positive breast cancer that is either locally advanced or metastatic. They should have already tried at least two previous treatments for their cancer. The trial is open to adults aged 65 to 74, regardless of gender. Participants can expect to receive the new treatment and will be closely monitored for its effects on their cancer and any side effects they might experience. This study is currently recruiting participants and aims to provide valuable information about this new treatment option for breast cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The main inclusion criteria include but are not limited to the following:
• • Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer
• • Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
• • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation
• • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
• • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention
• Arm 1:
• • Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
• • Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment
• Arm 2:
• • -Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
• Arm 3:
• • -Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.
• Exclusion Criteria:
• The main exclusion criteria include but are not limited to the following:
• • Uncontrolled or significant cardiovascular disease
• • History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease
• • Has clinically severe respiratory compromise
• • Has any history of or evidence of any current leptomeningeal disease
• • Has clinically significant corneal disease
• • Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
• • HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• • Known additional malignancy that is progressing or has required active treatment within the past 3 years
• • Evidence of spinal cord compression or brain metastases
• • Has an active infection requiring systemic therapy
• • Concurrent active HBV and HCV infection
• • Has had major surgical procedure (excluding placement of vascular access) less than 28 days
• • Arm 3 ONLY
• • - Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting