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New treatment option for Breast Neoplasms
Official title Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
ClinicalTrials.gov ID: NCT06797635
What this study is testing
What is Patritumab deruxtecan?
Patritumab deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast neoplasms.
Also referred to as MK-1022, HER3-DXd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn: About the safety of the study treatments and if people tolerate them If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main 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)...
- Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the...
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at...
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
You likely can't join if
- 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
See the full eligibility criteria
- The main 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
- Skokie, Illinois, United States
- Billings, Montana, United States
- Tigard, Oregon, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Norfolk, Virginia, United States
- Seoul, South Korea
- Badalona, Catalonia, Spain
- Madrid, Madrid, Comunidad de, Spain
- Córdoba, Spain
- Taichung, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States; Skokie, Illinois, United States; Billings, Montana, United States; Tigard, Oregon, United States; Nashville, Tennessee, United States; Dallas, Texas, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.