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

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 study investigates the safety and efficacy of combining patritumab deruxtecan and pembrolizumab with chemotherapy in patients with high-risk early-stage triple-negative breast cancer (TNBC) or hormone receptor-low positive/HER2 negative breast cancer. Participants will receive these treatments before surgery, and the study aims to determine if this combination leads to a greater reduction in cancer cells compared to standard treatment with pembrolizumab and chemotherapy alone. The study will also assess how well patients tolerate the new treatment regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

* Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2
* Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation/randomization
* Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan

Exclusion Criteria:

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

* Has uncontrolled or significant cardiovascular disease before randomization
* Has any history of or evidence of any current leptomeningeal carcinomatosis.
* Has clinically significant corneal disease
* Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease
* Has evidence of ongoing, uncontrolled, systemic bacterial, fungal, or viral infection
* Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
* Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
* Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)
* Has metastatic (Stage IV) breast cancer or cN3 nodal involvement
* Has known additional malignancy that is progressing or has required active treatment within the past 5 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current or suspected ILD
* Has an active infection requiring systemic therapy
* Has concurrent active HBV and HCV infection
* Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness

Where it's running

• UCLA Hematology/Oncology - Parkside ( Site 0021)
  Santa Monica, California, United States Recruiting
• Orchard Healthcare Research Inc. ( Site 0006)
  Skokie, Illinois, United States Recruiting
• Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)
  Billings, Montana, United States Recruiting
• Northwest Cancer Specialists (Compass Oncology) ( Site 8003)
  Tigard, Oregon, United States Recruiting
• SCRI Oncology Partners ( Site 7000)
  Nashville, Tennessee, United States Recruiting
• Texas Oncology - DFW ( Site 8000)
  Dallas, Texas, United States 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.

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• New treatment approach for BRCA1/2 mutated triple negative breast cancer

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

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• Preoperative chemotherapy with pembrolizumab and a low or high radiation boost for node-positive triple-negative breast cancer

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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.