RECRUITING

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)

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Conditions

Breast NeoplasmsBreast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-02-26
Study Completion:2029-09-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06686394

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer
  2. * Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
  3. * 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
  4. * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
  5. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention
  6. * 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
  7. * Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment
  1. * Uncontrolled or significant cardiovascular disease
  2. * History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease
  3. * Has clinically severe respiratory compromise
  4. * Has any history of or evidence of any current leptomeningeal disease
  5. * Has clinically significant corneal disease
  6. * Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
  7. * HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  8. * Known additional malignancy that is progressing or has required active treatment within the past 3 years
  9. * Evidence of spinal cord compression or brain metastases
  10. * Has an active infection requiring systemic therapy
  11. * Concurrent active HBV and HCV infection
  12. * Has had major surgical procedure (excluding placement of vascular access) less than 28 days

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-26
Study Completion Date2029-09-10

Study Record Updates

Study Start Date2025-02-26
Study Completion Date2029-09-10

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Neoplasms
  • Breast Cancer