Clinical Trials for Human Epidermal Growth Factor Receptor Negative Breast Cancer
Currently, there is 1 ongoing clinical trial studying treatments for human epidermal growth factor receptor negative breast cancer. This trial is exploring a combination of targeted therapy and immunotherapy drugs for patients with high-risk early-stage triple-negative or hormone receptor-low positive breast cancer.
Clinical trial locations
Study of Patritumab Deruxtecan and Pembrolizumab for Patients with High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive Breast Cancer
This clinical trial is evaluating treatment options for patients with high-risk early-stage breast cancer that is either triple-negative or hormone receptor-low positive with HER2 negativity. The study is being conducted in Spain and focuses on testing a combination of different medications to determine the most effective treatment approach.
Who can participate:
To be eligible for this trial, participants must have locally advanced breast cancer that has not spread to other parts of the body. They must have a confirmed diagnosis of either triple-negative breast cancer or hormone receptor-low positive/HER2-negative breast cancer. Participants should be able to carry out daily activities with minimal symptoms, as measured by an ECOG performance status of 0 to 1. Their heart function must be adequate, with a left ventricular ejection fraction of 50% or higher. Participants with hepatitis B must have been on antiviral therapy for at least 4 weeks with undetectable viral load, and those with a history of hepatitis C must also have an undetectable viral load. Both women and men are welcome to participate.
Who cannot participate:
The trial excludes patients who have experienced severe allergic reactions to any of the study drugs or who have received other cancer treatments within the last 4 weeks. Patients with uncontrolled medical conditions such as heart disease, high blood pressure, or diabetes are not eligible. Pregnant or breastfeeding women cannot participate. Other exclusion criteria include active infections requiring treatment, a history of another cancer within the past 5 years (except certain skin cancers or in situ cervical cancer), cancer that has spread to the brain, autoimmune diseases, recent live vaccines within 30 days, or a history of substance abuse within the last 12 months.
What the trial involves:
The study examines the safety and effectiveness of combining several medications given in different sequences. The main investigational drugs being tested are patritumab deruxtecan (also known as MK-1022) and pembrolizumab (also known as Keytruda). Patritumab deruxtecan is a targeted therapy that attaches to a specific protein called HER3 on cancer cells and delivers an anti-cancer drug directly into them. Pembrolizumab is an immunotherapy drug that helps the immune system fight cancer by blocking a protein called PD-1, which normally prevents the immune system from attacking cancer cells.
Participants will also receive additional chemotherapy medications including carboplatin and paclitaxel, which work by damaging cancer cell DNA and interfering with cell division. Some patients may also receive epirubicin hydrochloride, doxorubicin hydrochloride, cyclophosphamide, capecitabine, or olaparib as part of their treatment regimen.
The treatment follows a structured timeline. After initial assessment and consent, participants receive patritumab deruxtecan and pembrolizumab through intravenous infusion. This is followed by a phase of carboplatin and paclitaxel combined with pembrolizumab. After completing these treatment phases, participants undergo surgery to remove any remaining cancerous tissue. Following surgery, additional pembrolizumab treatment is given to help prevent cancer recurrence. Throughout the study, participants attend regular follow-up appointments to monitor their health and assess treatment effectiveness.
All medications are administered either through intravenous infusion (directly into a vein) or orally (by mouth), depending on the specific drug. The study will compare the effects of these treatments when given before or after surgery and will monitor participants for several years to gather comprehensive data on safety and effectiveness.
Summary
Currently, there is only one clinical trial available for patients with human epidermal growth factor receptor negative breast cancer, specifically focusing on high-risk early-stage triple-negative or hormone receptor-low positive subtypes. This trial, located in Spain, represents an important research effort combining targeted therapy with immunotherapy and chemotherapy. The study is particularly notable for its comprehensive approach, testing multiple medications in different sequences to identify the optimal treatment strategy for these aggressive forms of breast cancer. Patients interested in participating should discuss their eligibility with their healthcare provider, keeping in mind the specific inclusion and exclusion criteria outlined in the trial protocol.
