Treatment of advanced HER2 positive breast cancer with patritumab deruxtecan and other agents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of patritumab deruxtecan in combination with other anticancer agents for patients with HER2 positive breast cancer that is locally advanced and cannot be surgically removed. Participants will receive treatment and be monitored for their cancer's response, including any reduction in tumor size. The study aims to gather data on how well patients tolerate the treatment and the overall effectiveness in managing their condition. The trial will take place across multiple countries, including the USA, Canada, and several others.

Why it matters

Who can join: the full rules

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

Part 1 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

Part 1 Arm 2:

-Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting

Part 1 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.

Part 2 : Has not received prior systemic therapy (including T-DXd) for recurrent locally advanced or metastatic breast cancer (mBC).

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Uncontrolled or significant cardiovascular disease
* Has any history of (noninfectious) interstitial lung disease (ILD)/ pneumonitis irrespective of steroid use or has current ILD or suspected ILD
* 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
* Part 1: Evidence of spinal cord compression or brain metastases
* Part 2: Evidence of spinal cord compression or brain/CNS 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

Part1: 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

Where it's running

• University of Colorado Anschutz Medical Campus ( Site 0057)
  Aurora, Colorado, United States Recruiting
• Dana-Farber Cancer Institute ( Site 0050)
  Boston, Massachusetts, United States Recruiting
• Rutgers Cancer Institute of New Jersey ( Site 0052)
  New Brunswick, New Jersey, United States Recruiting
• Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)
  Greenville, South Carolina, United States Recruiting
• Inova Schar Cancer Institute ( Site 0051)
  Fairfax, Virginia, United States Recruiting
• Kingston General Hospital ( Site 0061)
  Kingston, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• New treatment approach for high-risk early-stage breast cancer

  This study is testing a new combination of treatments for people with high-risk early-stage triple-negative breast cancer to see if it can shrink tumors more than the usual treatment before surgery.

  Recruiting at 17 sites Phase 2 Merck Sharp & Dohme LLC · Santa Monica, California and 16 other locations · NCT06797635

• ATUSA 3D automated breast ultrasound for suspicious breast lesions

  This study will test whether the ATUSA 3D automated breast ultrasound system can produce high-quality images that match biopsy results in women with BI-RADS 4 or 5 breast findings.

  Recruiting at 2 sites iSono Health, Inc. · Sacramento, California and 1 other locations · NCT07505797

• Prehabilitation plus ongoing exercise and nutrition support for women with breast cancer

  This trial will test whether a short supervised pre-treatment program of high-intensity exercise and personalized nutrition followed by home-based exercise and dietary guidance helps newly diagnosed women with stage 0–III breast cancer recover better and tolerate treatment.

  Recruiting at 2 sites European University Miguel de Cervantes · Valladolid, Valladolid and 1 other locations · NCT07467824

• HandX-assisted endoscopic nipple-sparing mastectomy (ATHENA I)

  This study tests whether a handheld robotic device called HandX can help surgeons safely perform a minimally invasive nipple-sparing mastectomy with immediate implant reconstruction for women having therapeutic or risk-reducing mastectomy.

  Recruiting Mediterraneo Hospital · Glyfada, Attica · NCT07292246

• Capecitabine with or without elacestrant for ER-positive advanced breast cancer

  This trial will try adding elacestrant to capecitabine to see if it helps people with ER-positive, HER2-negative advanced breast cancer that stopped responding to CDK4/6 inhibitors.

  Recruiting Phase 2 Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07222215

• Patritumab deruxtecan for HR+/HER2- unresectable locally advanced or metastatic breast cancer

  This trial tests whether patritumab deruxtecan helps people with hormone receptor–positive, HER2‑negative advanced breast cancer who have progressed on CDK4/6 inhibitor plus endocrine therapy live longer or have slower cancer growth compared with standard chemotherapy.

  Recruiting at 203 sites Phase 3 Merck Sharp & Dohme LLC · Daphne, Alabama and 205 other locations · NCT07060807

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.