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HER2 negative breast cancer – Trials in Disease

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Clinical Trials for HER2 Negative Breast Cancer

There are currently 30 ongoing clinical trials for HER2 negative breast cancer across Europe. These trials are exploring various treatment approaches including immunotherapy, hormone therapy, targeted therapies, and chemotherapy combinations. The studies focus on different stages of the disease, from early breast cancer to advanced and metastatic forms, with trials taking place in multiple European countries.

Clinical trial locations

Study Comparing DB-1303 and Chemotherapy for Patients with HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

This trial is studying patients with metastatic breast cancer that shows low levels of the HER2 protein and is positive for hormone receptors. Participants must be adults with good organ and bone marrow function who have received adequate breaks from previous treatments. The study requires measurable disease and specific hormone receptor characteristics.

The main exclusion criteria include having other types of cancer, not meeting age requirements, inability to follow study procedures, pregnancy or breastfeeding, recent participation in other trials, allergies to study medications, and certain infections or medical conditions.

The trial compares the experimental medication DB-1303 with standard chemotherapy options chosen by doctors. DB-1303 is an anti-HER2 antibody drug conjugate delivered through intravenous infusion, designed to target cancer cells with low HER2 levels. The study aims to determine if DB-1303 is more effective than traditional chemotherapy in extending the time before cancer progresses.

Study Comparing Giredestrant with Endocrine Therapy for Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

This study focuses on early breast cancer that is estrogen receptor-positive and HER2-negative. Participants must have specific tumor characteristics confirmed by testing, including grade and proliferation markers. The trial requires documented hormone receptor status and adequate organ function.

Patients with different cancer types, those outside specified age ranges, and those in vulnerable populations are excluded. The trial compares the medication giredestrant with standard hormone therapies including exemestane, letrozole, anastrozole, and tamoxifen.

The investigational drug giredestrant is a selective estrogen receptor degrader that works by binding to and degrading estrogen receptors, which can slow cancer cell growth. The study aims to assess whether giredestrant is more effective than standard hormone therapies in preventing cancer recurrence, with treatment continuing for up to several years.

Study of Disitamab Vedotin and Tucatinib for Patients with Advanced Breast Cancer or Gastric Cancer

This trial examines advanced cancers including breast cancer that cannot be surgically removed or has spread. Patients must be at least 18 years old with confirmed diagnosis of metastatic cancer and specific HER2 status. The study requires measurable disease and adequate heart, bone marrow, liver, and kidney function.

Exclusions include patients with different cancer types, those not in the specified age range, inability to follow procedures, and other serious health conditions. The trial tests disitamab vedotin, administered intravenously, either alone or combined with tucatinib taken orally.

Disitamab vedotin is an antibody-drug conjugate that targets the HER2 protein on cancer cells, delivering a toxic agent to inhibit their growth. The study explores both medications’ safety and effectiveness in different patient groups, including those with HER2-low and HER2-positive breast cancer.

Study of Elacestrant and Ribociclib for Patients with Endocrine-Responsive HER2-Negative Early Breast Cancer

This study involves women and men aged 18 or older with confirmed HER2-negative, estrogen receptor-positive invasive breast cancer. Participants must have good performance status and adequate blood counts, liver, and kidney function. Normal heart function is required, with specific measurements for heart rhythm and pumping ability.

The trial excludes patients with different breast cancer types, those outside the age range, and those unable to follow procedures or take medications properly. The study compares a combination of elacestrant and ribociclib with a combination of an aromatase inhibitor and ribociclib.

Elacestrant is a selective estrogen receptor degrader that blocks estrogen’s effects on cancer cells. Ribociclib is a CDK4/6 inhibitor that slows cancer cell division. The trial evaluates which combination is more effective as neoadjuvant therapy given before surgery to shrink tumors, with treatment lasting up to six months.

Study of Giredestrant, Triptorelin, and Anastrozole in Premenopausal Women with ER-Positive/HER2-Negative Early Breast Cancer

This trial focuses on premenopausal women aged 18 or older with operable breast cancer that is estrogen receptor-positive and HER2-negative. Participants must have tumors at least 1.0 cm in size with specific proliferation markers. The study requires normal heart function, adequate blood counts, and organ function.

Men are excluded, as are patients who don’t meet specific hormonal or tumor criteria. The study compares different hormone therapy combinations including giredestrant with triptorelin, and anastrozole with triptorelin.

Giredestrant works by degrading estrogen receptors to reduce cancer cell growth. Triptorelin lowers hormone production to reduce estrogen levels. Anastrozole blocks estrogen production. The trial evaluates these treatments over four weeks to determine their effects on cancer cell activity before surgery.

Study of OP-1250 for Treating Advanced or Metastatic ER+, HER2- Breast Cancer in Patients After Endocrine and CDK4/6 Inhibitor Therapy

This study involves adult patients with estrogen receptor-positive, HER2-negative breast cancer that has spread and shown progression despite previous treatments with hormone therapy and CDK4/6 inhibitors. Participants must have good performance status and adequate organ function.

The trial excludes those who haven’t received prior CDK4/6 inhibitor and endocrine therapy, patients with different cancer types, and those outside the specified criteria. The study compares OP-1250 (also called Palazestrant) with standard hormone therapies including fulvestrant, goserelin, anastrozole, exemestane, and letrozole.

OP-1250 is a selective estrogen receptor degrader that works by targeting and breaking down estrogen receptors on cancer cells. The medication is taken orally as tablets. The trial assesses safety and effectiveness over periods up to 42 days, monitoring how well it works compared to standard treatments.

Study of Trastuzumab Deruxtecan for Patients with Unresectable or Metastatic HER2-low or HER2 IHC0 Breast Cancer

This trial focuses on breast cancer that cannot be surgically removed or has spread to other parts of the body, with low or absent HER2 expression. Patients must have adequate heart function with left ventricular ejection fraction of at least 50%. The study requires good organ and bone marrow function and at least one measurable tumor lesion.

Exclusions include patients with different cancer types, those not meeting age requirements, and those in vulnerable populations. The trial tests trastuzumab deruxtecan (T-DXd), an anti-HER2 antibody drug conjugate given through intravenous infusion.

The medication works by targeting and attaching to the HER2 protein on cancer cells, delivering chemotherapy directly to them. This targeted approach helps destroy cancer cells while minimizing damage to healthy tissue. The study evaluates how effectively this treatment controls cancer progression.

Study on Elacestrant for Treating ER+/HER2- Breast Cancer in Patients with ctDNA Relapse

This study involves patients with estrogen receptor-positive, HER2-negative breast cancer who show circulating tumor DNA in their blood after completing standard treatments. Participants must have received 4.5 to 7 years of hormone therapy and plan to continue it. The trial requires adequate organ function and good performance status.

The trial excludes those with different cancer types, those experiencing recurrence without ctDNA detection, and patients outside specified criteria. The study compares elacestrant with standard hormone therapies including tamoxifen, anastrozole, exemestane, and letrozole.

Elacestrant is a selective estrogen receptor degrader that works by breaking down estrogen receptors to prevent cancer cell growth. The medication is taken orally in tablet form. The trial aims to determine if elacestrant can delay cancer spread or prevent death better than standard therapies in patients with detectable ctDNA.

Study on Giredestrant and Fulvestrant with CDK4/6 Inhibitor for Patients with ER+ HER2-Negative Advanced Breast Cancer Resistant to Endocrine Therapy

This trial examines advanced breast cancer that is estrogen receptor-positive and HER2-negative, which has become resistant to prior hormone therapy. Patients must have confirmed ESR1 mutation in blood tests and measurable disease. The study requires good performance status and adequate organ function.

Exclusions include patients without the specific cancer type, ESR1 mutation, or those outside eligibility criteria. The study compares giredestrant with fulvestrant, both combined with CDK4/6 inhibitors including abemaciclib, ribociclib, and palbociclib.

Giredestrant works by selectively targeting and blocking estrogen receptors to slow cancer cell growth. Fulvestrant binds to and breaks down estrogen receptors. CDK4/6 inhibitors block proteins involved in cell division. The trial evaluates which combination is more effective in managing cancer that has stopped responding to standard hormone treatments.

Study on Ifinatamab Deruxtecan for Patients with Recurrent or Metastatic Solid Tumors

This study includes patients at least 18 years old with various cancers that have returned or spread, including HER2-low and HER2 IHC 0 breast cancer. Participants must have at least one measurable tumor lesion and good performance status. The trial requires adequate organ function and documented disease progression after previous treatments.

Patients with non-recurrent or non-metastatic tumors, those without measurable disease, and those outside age requirements are excluded. The study tests ifinatamab deruxtecan (I-DXd), administered through intravenous infusion.

This medication is an antibody-drug conjugate designed to target specific proteins on cancer cell surfaces. Once attached, it delivers a powerful drug directly into cancer cells to stop their growth. The trial evaluates safety and effectiveness in shrinking tumors across various solid tumor types.

Study on Preoperative Treatment for HER2-Negative Breast Cancer Using Pembrolizumab, Paclitaxel, and Carboplatin in Patients Not Responding to Initial Chemotherapy

This trial focuses on HER2-negative breast cancer patients not responding well to initial chemotherapy. Participants must be over 18 years old with good health status and adequate blood, liver, and kidney function. The study requires sufficient heart function and no contraindications to radiation treatment.

Exclusions include patients who haven’t recovered from previous treatments, those with serious heart problems or uncontrolled infections, and pregnant or breastfeeding women. The trial tests pembrolizumab combined with stereotactic radiation therapy and standard chemotherapy including paclitaxel and carboplatin.

Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells. It blocks a protein that prevents immune cells from attacking cancer. The combination aims to improve treatment outcomes before surgery, with regular monitoring throughout the study period.

Summary

The clinical trials for HER2 negative breast cancer show a strong geographical concentration in Western and Central European countries, with Germany, Spain, France, Italy, and Poland hosting the most studies. Several notable trends emerge from these 30 ongoing trials.

Multiple trials focus on hormone receptor-positive disease, particularly testing new selective estrogen receptor degraders like giredestrant, elacestrant, and OP-1250. These medications represent a new generation of hormone therapies that work by breaking down estrogen receptors rather than simply blocking them.

CDK4/6 inhibitors feature prominently, either as combination partners with hormone therapy or as subjects of resistance studies. Several trials examine what happens when cancer becomes resistant to these widely-used medications, exploring new treatment combinations to overcome resistance.

Antibody-drug conjugates represent another major research focus, with trials testing DB-1303, disitamab vedotin, trastuzumab deruxtecan, datopotamab deruxtecan, and ifinatamab deruxtecan. These medications deliver chemotherapy directly to cancer cells by targeting specific proteins on their surfaces.

The trials address different disease stages, from early breast cancer treated before or after surgery to advanced and metastatic disease. Several studies examine patients with specific genetic mutations like BRCA or ESR1, recognizing that cancer’s molecular characteristics influence treatment response.

Immunotherapy combinations appear in multiple trials, particularly pembrolizumab combined with chemotherapy or other treatments. This reflects growing interest in harnessing the immune system to fight breast cancer.

The diversity of trial designs, from dose-finding studies to large comparison trials, demonstrates the field’s active exploration of new treatment approaches for HER2 negative breast cancer across its various subtypes and stages.

Ongoing Clinical Trials on HER2 negative breast cancer

  • Study on Irinotecan for Brain Metastases in Patients with HER2-Negative Breast Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Impact of Fluoroestradiol F-18 PET on Treatment for Patients with ER+ HER2- Metastatic Breast Cancer After First-Line Hormone Therapy Relapse

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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