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)
The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
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.
You may not be if
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
Clareo Health | 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)