Human epidermal growth factor receptor negative – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Wed, 24 Jun 2026 04:12:24 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Human epidermal growth factor receptor negative – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 A Study Comparing GDC-4198 Alone and with Giredestrant versus Abemaciclib with Giredestrant for Advanced Breast Cancer After Previous CDK4/6 Treatment https://clinicaltrials.eu/trial/a-study-comparing-gdc-4198-alone-and-with-giredestrant-versus-abemaciclib-with-giredestrant-for-advanced-breast-cancer-after-previous-cdk4-6-treatment/ Thu, 30 Apr 2026 13:08:29 +0000 https://clinicaltrials.eu/trial/a-study-comparing-gdc-4198-alone-and-with-giredestrant-versus-abemaciclib-with-giredestrant-for-advanced-breast-cancer-after-previous-cdk4-6-treatment/ This study involves people with breast cancer that is estrogen receptor-positive and HER2-negative, meaning the cancer cells have receptors for the hormone estrogen but do not have high levels of a protein called HER2. The cancer has either spread to other parts of the body or has grown locally in a way that cannot be treated with surgery or radiation aimed at curing the disease. All participants in this study have already received treatment with a type of medicine called a CDK4/6 inhibitor, which works by blocking certain proteins that help cancer cells grow, but their cancer has continued to grow or spread despite this treatment. The study will test several medicines given by mouth: GDC-4198, which is also known as RO7840734, giredestrant, which is also known as RO7197597, and abemaciclib. GDC-4198 is a new type of CDK4/6 inhibitor, while giredestrant works by blocking estrogen receptors on cancer cells, and abemaciclib is an already approved CDK4/6 inhibitor.

The purpose of this study is to find out if GDC-4198 is safe when given alone or together with giredestrant, and to compare how well GDC-4198 combined with giredestrant works against cancer compared to abemaciclib combined with giredestrant. The study will also look at how the body processes these medicines and how they affect the cancer. The study is divided into two stages. In the first stage, a small number of participants will receive GDC-4198 either alone or with giredestrant to check for safety and to understand how the body handles the medicine. In the second stage, a larger number of participants will be randomly assigned to receive either one of two different doses of GDC-4198 combined with giredestrant, or abemaciclib combined with giredestrant. Throughout the study, doctors will monitor participants closely with regular check-ups, blood tests, and scans to see how the cancer responds to treatment and to watch for any side effects.

During the study, doctors will measure several things to understand how well the treatments work and how safe they are. They will check how long it takes before the cancer starts growing again, whether the cancer shrinks or disappears, and how long any improvement lasts. They will also track any unwanted effects from the medicines, changes in vital signs like blood pressure and heart rate, and results from blood tests. The study will also measure the levels of the medicines in the blood at different times to understand how the body processes them. Some participants will receive GDC-4198 with and without food to see if eating affects how the medicine works. The study will continue for several years to gather enough information about the long-term effects of these treatments.

]]> Study of elacestrant and ribociclib compared to standard treatment for patients with high-risk ER+/HER2- early breast cancer https://clinicaltrials.eu/trial/study-of-elacestrant-and-ribociclib-compared-to-standard-treatment-for-patients-with-high-risk-er-her2-early-breast-cancer/ Wed, 29 Apr 2026 15:09:25 +0000 https://clinicaltrials.eu/trial/study-of-elacestrant-and-ribociclib-compared-to-standard-treatment-for-patients-with-high-risk-er-her2-early-breast-cancer/ This study focuses on individuals with early breast cancer that is ER+/HER2-. This means the cancer cells have receptors for estrogen (ER+) but do not have an excess of a specific protein called human epidermal growth factor receptor 2 (HER2-). The research aims to compare the effectiveness of a new treatment approach against the current standard of care to see which better prevents the cancer from returning or causing death.

Participants may receive elacestrant, which is a type of medication used to block the effects of hormones that help cancer grow. Some individuals might also be given ribociclib, a medication known as a CDK4/6 inhibitor that helps stop cancer cells from dividing. The treatments are administered as oral use tablets. Depending on the group assigned, some participants may receive these medications alone or in combination with other standard hormone therapies, and some may receive a placebo.

The study follows participants over a period of time to monitor how they respond to the different medication combinations. The process involves tracking long-term outcomes, such as overall survival, which is the length of time from the initial diagnosis until death, and disease-free survival, which measures the time during and after treatment that a person lives without any signs or symptoms of the cancer. The researchers will also look at how the treatments affect the quality of life and any side effects that may occur during the study period.

]]> Study of Simvastatin with Nivolumab and Oxaliplatin for Patients with Advanced Stomach or Esophageal Cancer with ARID1A Mutation https://clinicaltrials.eu/trial/study-of-simvastatin-with-nivolumab-and-oxaliplatin-for-patients-with-advanced-stomach-or-esophageal-cancer-with-arid1a-mutation/ Wed, 29 Apr 2026 15:05:09 +0000 https://clinicaltrials.eu/trial/study-of-simvastatin-with-nivolumab-and-oxaliplatin-for-patients-with-advanced-stomach-or-esophageal-cancer-with-arid1a-mutation/ This clinical trial is focused on studying a type of cancer called advanced gastroesophageal carcinoma, which affects the stomach and esophagus. The study specifically looks at cases where the cancer is HER2 negative and has a genetic change known as ARID1A mutation. The trial aims to evaluate the effectiveness of a treatment combination that includes the drug Simvastatin, which is commonly used to lower cholesterol, alongside Nivolumab and Oxaliplatin-based chemotherapy. Nivolumab, also known by its code name BMS936558, is a medication that helps the immune system fight cancer, while Oxaliplatin is a chemotherapy drug that kills cancer cells.

The purpose of the study is to see how well this combination works in preventing the cancer from getting worse over a year. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will also include other medications like Fluorouracil, known as 5-FU, and Calcium Levofolinate, which help enhance the effects of chemotherapy. Additionally, some participants may receive Simvastatin in tablet form to see if it improves treatment outcomes.

Throughout the study, participants will be monitored to assess how the cancer responds to the treatment and to check for any side effects. The study will last up to 60 weeks, during which the health and quality of life of the participants will be regularly evaluated. The goal is to determine if this treatment approach can help patients live longer without the cancer progressing. The trial will also compare results with a group of patients who do not have the ARID1A mutation to see if there are differences in treatment effectiveness.

]]> Study of Patritumab Deruxtecan and Pembrolizumab for Patients with High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive Breast Cancer https://clinicaltrials.eu/trial/study-of-patritumab-deruxtecan-and-pembrolizumab-for-patients-with-high-risk-early-stage-triple-negative-or-hormone-receptor-low-positive-breast-cancer/ Wed, 29 Apr 2026 15:04:28 +0000 https://clinicaltrials.eu/trial/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 focused on studying treatments for a type of breast cancer known as high-risk early-stage triple-negative breast cancer or hormone receptor-low positive/HER2-negative breast cancer. The study involves several medications, including patritumab deruxtecan (also known as MK-1022), pembrolizumab (also known as Keytruda), carboplatin, paclitaxel, epirubicin hydrochloride, doxorubicin hydrochloride, cyclophosphamide, capecitabine, and olaparib. These medications are used in different combinations to explore their safety and effectiveness in treating the specified types of breast cancer.

The purpose of the study is to evaluate the safety and effectiveness of these treatments when given in different sequences. Participants will receive these medications through intravenous infusion, which means the medicine is given directly into a vein, or orally, which means the medicine is taken by mouth. The study will compare the effects of these treatments when given before or after surgery, as well as their impact on the cancer’s response to treatment.

Throughout the study, participants will be monitored for any side effects and the overall response of their cancer to the treatment. The study aims to determine the best treatment sequence to improve outcomes for patients with these specific types of breast cancer. The trial will continue for several years to gather comprehensive data on the effectiveness and safety of the treatments being tested.

]]> Study Comparing Ribociclib and Endocrine Therapy to Chemotherapy for Patients with Intermediate-Risk HR+/HER2- Early Breast Cancer https://clinicaltrials.eu/trial/study-comparing-ribociclib-and-endocrine-therapy-to-chemotherapy-for-patients-with-intermediate-risk-hr-her2-early-breast-cancer/ Wed, 29 Apr 2026 14:58:50 +0000 https://clinicaltrials.eu/trial/study-comparing-ribociclib-and-endocrine-therapy-to-chemotherapy-for-patients-with-intermediate-risk-hr-her2-early-breast-cancer/ This clinical trial is focused on studying a type of breast cancer known as HR-positive/HER2-negative early breast cancer. The study is comparing two treatment options for patients with this type of cancer. One group will receive a combination of endocrine therapy and a medication called ribociclib (also known by its code name, LEE011), while the other group will receive standard chemotherapy. The purpose of the study is to determine if the combination of endocrine therapy and ribociclib is more effective than chemotherapy in preventing the cancer from returning.

Participants in the study will take part in a treatment period that can last up to 24 months. During this time, they will receive either the combination of endocrine therapy and ribociclib or chemotherapy. The study aims to observe the participants over a period of time to see how well the treatments work in preventing the cancer from coming back and to monitor the overall health and quality of life of the participants.

The study will also look at how well participants adhere to their treatment plans, which means how consistently they take their medication as prescribed. Additionally, researchers will collect information on the participants’ response to treatment, including any changes in the size of the tumor and the rate of breast-conserving surgeries. The ultimate goal is to find the most effective treatment option for patients with HR-positive/HER2-negative early breast cancer, improving their chances of living without the disease returning.

]]> Study on Abemaciclib with Endocrine Therapy for Patients with HR+/HER2- Early Breast Cancer at Intermediate to High Risk https://clinicaltrials.eu/trial/study-on-abemaciclib-with-endocrine-therapy-for-patients-with-hr-her2-early-breast-cancer-at-intermediate-to-high-risk/ Wed, 29 Apr 2026 14:25:48 +0000 https://clinicaltrials.eu/trial/study-on-abemaciclib-with-endocrine-therapy-for-patients-with-hr-her2-early-breast-cancer-at-intermediate-to-high-risk/ This clinical trial is focused on studying a type of breast cancer known as HR-positive/HER2-negative early breast cancer. The study is investigating a treatment that combines a medication called abemaciclib with standard hormone therapy, which is commonly used after initial cancer treatment to help prevent the cancer from returning. Abemaciclib is a type of drug known as a CDK4/6 inhibitor, which works by interfering with cancer cell growth. The purpose of the study is to see if adding abemaciclib to the standard hormone therapy is more effective than using the hormone therapy alone.

Participants in the study will be randomly assigned to one of two groups. One group will receive the combination of abemaciclib and standard hormone therapy, while the other group will receive only the standard hormone therapy. The study will be conducted in an open-label manner, meaning that both the participants and the researchers will know which treatment each participant is receiving. The treatment period will last up to 24 months, during which participants will take the medication orally in the form of film-coated tablets. Throughout the study, participants will be monitored regularly to assess their health and the effectiveness of the treatment.

The main goal of the study is to determine if the combination of abemaciclib and standard hormone therapy can improve the time participants remain free from invasive breast cancer compared to those receiving only the standard hormone therapy. Additionally, the study will look at other outcomes, such as overall survival and quality of life, to provide a comprehensive understanding of the treatment’s impact. Participants will be followed for several years to gather long-term data on the effectiveness and safety of the treatment.

]]> Study on Giredestrant and Fulvestrant with CDK4/6 Inhibitor for Patients with ER+ HER2-Negative Advanced Breast Cancer Resistant to Endocrine Therapy https://clinicaltrials.eu/trial/study-on-giredestrant-and-fulvestrant-with-cdk4-6-inhibitor-for-patients-with-er-her2-negative-advanced-breast-cancer-resistant-to-endocrine-therapy/ Wed, 29 Apr 2026 14:25:23 +0000 https://clinicaltrials.eu/trial/study-on-giredestrant-and-fulvestrant-with-cdk4-6-inhibitor-for-patients-with-er-her2-negative-advanced-breast-cancer-resistant-to-endocrine-therapy/ This clinical trial is focused on studying treatments for estrogen receptor-positive, HER2-negative advanced breast cancer, a type of breast cancer that grows in response to the hormone estrogen and does not have an excess of the HER2 protein. The study will compare the effectiveness and safety of two medications: Giredestrant and Fulvestrant. Both medications will be used in combination with a CDK4/6 inhibitor, which is a type of drug that helps stop cancer cells from growing by targeting specific proteins involved in cell division.

The purpose of the study is to evaluate how well these treatments work in patients whose cancer has become resistant to previous hormone therapy. Participants will be randomly assigned to receive either Giredestrant or Fulvestrant, along with a CDK4/6 inhibitor. The study will monitor the participants over a period of time to assess the progression of the disease and any side effects experienced. The trial aims to provide insights into which treatment combination might be more effective in managing this type of breast cancer.

Throughout the study, participants will receive regular check-ups and assessments to track their health and the cancer’s response to the treatment. The trial will also gather information on the overall survival of participants and any changes in their quality of life. This research is important for understanding better treatment options for patients with advanced breast cancer that is resistant to standard hormone therapies.

]]> Study Comparing Oral Paclitaxel (DHP107) and IV Paclitaxel for Patients with Recurrent or Metastatic HER2 Negative Breast Cancer https://clinicaltrials.eu/trial/study-comparing-oral-paclitaxel-dhp107-and-iv-paclitaxel-for-patients-with-recurrent-or-metastatic-her2-negative-breast-cancer/ Wed, 29 Apr 2026 14:22:57 +0000 https://clinicaltrials.eu/trial/study-comparing-oral-paclitaxel-dhp107-and-iv-paclitaxel-for-patients-with-recurrent-or-metastatic-her2-negative-breast-cancer/ This clinical trial is focused on studying a type of breast cancer known as HER2-negative breast cancer, which can either come back after treatment or spread to other parts of the body. The study is comparing two forms of a cancer treatment called paclitaxel. One form is taken by mouth as an oral solution known as DHP107, and the other is given through a vein as an intravenous infusion called TAXOL. The purpose of the study is to see how well the oral form of paclitaxel works compared to the intravenous form in treating this type of breast cancer.

Participants in the study will receive either the oral or intravenous form of paclitaxel. The study will monitor how long the cancer does not get worse, which is known as progression-free survival. Other aspects being observed include how well the cancer responds to the treatment, the overall survival of participants, and the time it takes for the treatment to stop working. The study will also look at the overall control of the disease and the quality of life of the participants.

This trial is designed to provide important information about the effectiveness and safety of oral paclitaxel compared to the intravenous form. It aims to help determine if the oral form can be a suitable first-line treatment option for patients with recurrent or metastatic HER2-negative breast cancer. The study is expected to continue until November 2025.

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