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)

Description

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment

Conditions

Breast Neoplasms, Breast Cancer

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Study Overview

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Study Details

Study overview

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment

HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

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)

Condition
Breast Neoplasms
Intervention / Treatment

-

Contacts and Locations

Greenville

Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053), Greenville, South Carolina, United States, 29605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2029-09-10