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Ongoing Clinical Trials for HER2 Positive Breast Cancer

This article provides detailed information about 37 ongoing clinical trials investigating new treatments for HER2 positive breast cancer across Europe. These studies are testing various medications and treatment approaches, including trastuzumab deruxtecan, tucatinib, and combination therapies, for patients at different stages of the disease. (Also known as: HER2+ breast cancer, HER2-overexpressing breast cancer)

Clinical trial locations

A Study of Trastuzumab Deruxtecan Treatment for Patients with Early-Stage HER2-Positive or HER2-Low Breast Cancer Who Show Signs of Molecular Relapse

This trial evaluates trastuzumab deruxtecan (Enhertu) for patients with early-stage HER2-positive or HER2-low breast cancer who show signs of disease activity in blood tests, even without visible cancer on scans. The study compares trastuzumab deruxtecan with standard care treatments.

Main inclusion criteria: Patients must be between 18 and 75 years old with HER2-positive or HER2-low breast cancer. They should have completed both pre-surgery and post-surgery trastuzumab-based therapy. Participants must be enrolled in the SURVIVE study and show evidence of early disease return in blood tests. The cancer should not show signs of spreading on imaging tests. Heart function must be adequate with a left ventricular ejection fraction of 50% or higher.

Main exclusion criteria: Patients under 18 years old, those with known metastatic disease, or those who have received previous anti-HER2 therapy are excluded. The trial does not include pregnant or breastfeeding women, patients with serious heart conditions, active infections, or severe liver or kidney disease.

Study focus: The research aims to determine how effectively the treatment clears disease markers from the blood. Treatment involves receiving trastuzumab deruxtecan through intravenous infusion for up to one year, with a maximum dose of 5.4 milligrams per kilogram of body weight. Patients will have regular check-ups, blood tests to monitor treatment response, and quality of life assessments. Special attention will be given to monitoring heart and lung function.

Investigational drug: Trastuzumab deruxtecan is a targeted cancer medication that combines two active components. It works by attaching to HER2 proteins on cancer cells and delivering chemotherapy directly to these cells, potentially causing less damage to healthy cells compared to traditional chemotherapy.

Study Comparing Trastuzumab Deruxtecan with Standard Treatment for Patients with HER2-positive Breast Cancer

This study tests whether trastuzumab deruxtecan works better than standard treatments in achieving a complete response in patients with HER2-positive breast cancer. The trial monitors participants to see if the cancer disappears completely in treated areas.

Main inclusion criteria: Participants must be 18 years or older, have HER2-positive breast cancer that has spread to other parts of the body, and show good physical performance status (ECOG score of 0 or 1). They need adequate heart function with a left ventricular ejection fraction of at least 50%, proper bone marrow function, and adequate kidney function. Women of childbearing potential must use effective birth control and have a negative pregnancy test. Participants must have received previous treatment with taxane, trastuzumab, and pertuzumab, with disease progression during or after the most recent treatment.

Main exclusion criteria: Patients who have previously been treated with trastuzumab deruxtecan, those with severe heart problems, uncontrolled high blood pressure, active infections requiring treatment, or pregnant/breastfeeding women are excluded. Patients currently participating in another clinical trial or with severe allergic reactions to similar drugs cannot join.

Study focus: The study evaluates the effectiveness of trastuzumab deruxtecan administered through intravenous infusion. Regular monitoring includes imaging tests, blood tests, and health evaluations. The research aims to determine whether this treatment can help patients achieve a complete response while monitoring for any side effects.

Investigational drug: Trastuzumab deruxtecan is a medication that targets and destroys cancer cells with high HER2 protein levels. It combines a HER2-targeted antibody with a chemotherapy drug, delivering treatment directly to cancer cells while minimizing exposure to healthy tissues.

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

This trial investigates the safety and effectiveness of disitamab vedotin, used alone or with tucatinib, for patients with advanced HER2-positive breast cancer or HER2-low gastric cancer. The study aims to find the optimal dose and assess how well these treatments work in different patient groups.

Main inclusion criteria: Patients must be at least 18 years old with confirmed diagnosis of either gastric/gastroesophageal junction adenocarcinoma or breast carcinoma. The cancer must be in a locally-advanced, unresectable, or metastatic stage. Participants must have a specific HER2 status confirmed by laboratory test and have experienced disease progression after standard treatments or be unable to tolerate these treatments. They need measurable disease, good performance status, adequate heart function (left ventricular ejection fraction of at least 50%), and adequate bone marrow, liver, and kidney function.

Main exclusion criteria: Patients with a different type of cancer than those being studied, those not in the specified age range, or those unable to follow study procedures are excluded. Patients with other serious health conditions, pregnant or breastfeeding women, and those who have participated in another clinical trial recently may not be eligible.

Study focus: The study involves administering disitamab vedotin through intravenous infusion and tucatinib as oral tablets. Regular monitoring assesses treatment response and manages side effects. The research evaluates safety, tolerability, and antitumor activity of these medications.

Investigational drugs: Disitamab vedotin is an antibody-drug conjugate that targets HER2 protein on cancer cells, delivering a toxic agent directly to inhibit their growth. Tucatinib is used in combination with disitamab vedotin to enhance treatment effectiveness.

Study of Trastuzumab Deruxtecan for Patients with HER2-Low Breast Cancer and New or Worsening Brain Metastases

This study evaluates trastuzumab deruxtecan in patients with HER2-low breast cancer that has spread to the brain. The research investigates how well this treatment works in reducing brain metastases and improving patient outcomes.

Main inclusion criteria: Patients must have received at least one line of treatment for advanced cancer and completed a washout period from previous treatments. They need a heart function test showing left ventricular ejection fraction of 50% or higher, good bone marrow and organ function, and recovered from side effects of previous treatments to a mild level (except hair loss). Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 7 months after. Men must also use birth control and not donate sperm during this time. Patients must be available for treatment and follow-up visits, be 18 years or older, and have HER2-low breast cancer with newly diagnosed or worsening brain metastases that do not need immediate local treatment.

Main exclusion criteria: Patients who do not have HER2-low breast cancer, those without brain metastases, patients whose brain metastases are not newly diagnosed or progressing, and those with leptomeningeal disease not associated with HER2-low breast cancer are excluded. The trial also excludes patients not within the specified age range or who are part of a vulnerable population.

Study focus: The trial provides trastuzumab deruxtecan through intravenous infusion. Regular monitoring includes brain scans, health assessments, and tracking of any side effects. The study aims to reduce the size or number of brain metastases and improve quality of life.

Investigational drug: Trastuzumab deruxtecan is an antibody-drug conjugate that targets HER2 protein on cancer cells, delivering a chemotherapy agent directly to help destroy them. It is being studied for its effectiveness in treating brain metastases.

Study on Long-Term Safety of Trastuzumab Deruxtecan for Patients with Advanced HER2-Positive or HER2-Mutated Solid Tumors

This trial monitors the long-term safety of trastuzumab deruxtecan in patients with advanced HER2-expressing or HER2-mutated solid tumors. The study provides continued access to treatment for patients benefiting from it while tracking adverse events.

Main inclusion criteria: Patients must be currently enrolled in a specific DS or DS/AZ sponsored study that has reached its end-of-study definition, with no evidence of disease progression and clinical benefit from the study drug. Participants of reproductive potential must use effective contraception during the study and for 7 months (females) or 4 months (males) after the last dose. Females must have a negative pregnancy test at screening, during treatment, and for 7 months after. Males must not donate sperm during the study and for at least 4 months after. Patients must sign a consent form and agree to follow all study requirements.

Main exclusion criteria: Patients with cancer that is not advanced or cannot be surgically removed, those whose cancer does not show HER2 protein changes, patients no longer benefiting from treatment, and those not monitored for long-term safety are excluded.

Study focus: The trial administers trastuzumab deruxtecan through intravenous infusion, with frequency and duration determined by ongoing clinical benefit and safety assessments. Long-term safety is monitored, including tracking adverse events that may lead to discontinuation or dose reduction.

Investigational drug: Trastuzumab deruxtecan is an antibody-drug conjugate that binds to HER2 receptors on cancer cells, delivering chemotherapy directly to inhibit their growth and survival.

Study on the Effectiveness of GP2 and Sargramostim for HER2 Positive Breast Cancer Patients with Residual Disease or High-Risk After Standard Therapy

This study evaluates GLSI-100 (a combination of GP2 and GM-CSF) for patients who have completed standard breast cancer treatments but still have a high risk of cancer returning. The research aims to determine if this combination can reduce recurrence risk.

Main inclusion criteria: Patients must be over 18 years old with a negative pregnancy test or proof of post-menopause (for women). Those of childbearing potential must agree to use reliable birth control. Participants must be HLA-A*02-positive (except in a special study group), have confirmed HER2/neu positive primary breast cancer, and have completed both neoadjuvant and adjuvant trastuzumab-based therapy. They must have been at Stage I, II, or III at diagnosis with remaining cancer after initial treatment, or Stage III with no remaining cancer. The study treatment must start within one year after finishing adjuvant therapy. Patients must have no signs of remaining breast cancer, an ECOG score of 0-2, and adequate organ function.

Main exclusion criteria: Patients who have not completed both neoadjuvant and postoperative adjuvant trastuzumab-based therapy, those who do not have a high risk of disease recurrence, patients who are not HLA-A*02 positive, and those who are not HER2/neu positive are excluded.

Study focus: The trial involves receiving GLSI-100 or a placebo through skin injection. Participants undergo regular follow-up visits to monitor health status and cancer recurrence. Blood tests and quality of life questionnaires are completed throughout the study period.

Investigational drugs: GLSI-100 (GP2 + GM-CSF) is a combination of a peptide vaccine and an immune system booster designed to help the body recognize and fight cancer cells expressing HER2/neu protein. Trastuzumab is a medication that targets HER2/neu protein on cancer cells and is part of standard care.

Study on the Effectiveness of Trastuzumab Deruxtecan in Patients with HER2-Positive Oligometastatic Breast Cancer

This trial evaluates trastuzumab deruxtecan for patients with HER2-positive oligometastatic breast cancer (cancer with a limited number of metastases). The study investigates whether this treatment can achieve a complete response in combination with other treatments.

Main inclusion criteria: Patients must have HER2-positive breast cancer confirmed by laboratory tests, with proof of metastatic spread and at least one confirmed metastatic area. They need ER-expression level determined, oligo-metastatic disease with up to three separate spots, and a disease-free period of at least 24 months if cancer returned after treatment. Participants must have measurable cancer according to RECIST1.1 criteria, be at least 18 years old, have WHO performance status of 0 or 1, and adequate organ function.

Main exclusion criteria: Patients without HER2-positive breast cancer, those without oligometastatic disease, patients not within the specified age range, and those not willing or able to follow study procedures are excluded.

Study focus: The treatment involves intravenous administration of trastuzumab deruxtecan. Regular monitoring includes imaging tests to track changes in cancer, with the primary goal of achieving a complete radiologic response. Additional treatments such as surgery or radiation may be planned depending on response.

Investigational drug: Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells targeting the HER2 protein, which is overexpressed in certain breast cancers.

Study on the Safety and Effects of Lutetium Lu-177 and ABY-271 in Patients with HER2-Positive Metastatic Breast Cancer

This study evaluates the safety and tolerability of [177Lu]Lu-ABY-271, which combines a radioactive substance (Lutetium Lu-177) with a protein (ABY-271) to target and treat HER2-positive metastatic breast cancer.

Main inclusion criteria: Patients must be at least 18 years old with a life expectancy of at least 3 months and HER2-positive metastatic breast cancer that cannot be surgically removed. They need a tumor lesion at least 15 mm in size, ECOG performance status of 2 or less, and negative pregnancy test (if of childbearing potential). Women must use adequate contraceptive methods from screening until 12 weeks after treatment. For Part A, patients must be in treatment or planning to start standard anti-tumor therapy. For Part B, patients must have progressive disease shown by imaging, have received at least 3 lines of standard therapy, and have no ongoing treatment-related side effects greater than grade 1 before starting the study drug.

Main exclusion criteria: The trial excludes patients without HER2-positive metastatic breast cancer, male patients, and those considered part of a vulnerable population.

Study focus: The study involves receiving a single intravenous infusion of [177Lu]Lu-ABY-271. Participants are monitored for adverse events, changes in vital signs, and heart function. The trial measures the absorbed dose in organs and tumors, as well as blood concentration of the medication.

Investigational drug: [177Lu]Lu-ABY-271 is a radiopharmaceutical that targets and binds to HER2 protein on cancer cells, delivering radiation directly to cancer cells to limit damage to healthy cells.

Study on Trastuzumab Deruxtecan for Patients with Metastatic HER2-Positive Breast Cancer

This trial explores how changes in cancer cells’ genetic material, which can lead to treatment resistance, can be detected using liquid biopsy (blood tests). The study monitors these changes over time to understand how they relate to treatment effectiveness.

Main inclusion criteria: Patients must be able to provide informed consent, have a life expectancy greater than 12 weeks, and no active or neurologically unstable brain metastases. If brain metastases were treated, patients must have recovered from radiation side effects with at least 2 weeks passing after treatment. Heart function (LVEF) must be at least 50% within 28 days before joining. Organs and bone marrow must be functioning well within 14 days before starting. Patients need a washout period from previous treatments and must agree to have blood samples taken regularly for liquid biopsy. They must be 18 years or older with confirmed adenocarcinoma that is advanced or metastatic and cannot be cured. The cancer must be HER2-positive with any hormone receptor status, and patients must have had no more than one previous treatment for advanced/metastatic cancer. They need evidence of cancer progression through imaging tests and at least one measurable tumor according to RECIST version 1.1 criteria. Performance status must be 0 or 1 on the ECOG scale.

Main exclusion criteria: Patients without metastatic HER2-positive breast cancer, those not within the specified age range, or those part of a vulnerable population are excluded.

Study focus: Participants receive trastuzumab deruxtecan through intravenous infusion. Regular monitoring includes physical examinations, blood tests, and imaging studies to assess response and detect genomic alterations. The study compares disease progression as detected by imaging and liquid biopsy.

Investigational drug: Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate that combines a HER2-targeted antibody with a chemotherapy drug, delivering treatment directly to cancer cells expressing the HER2 protein.

Study on Trastuzumab Deruxtecan, Trastuzumab, and Pertuzumab for Patients with HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer

This trial evaluates a two-step treatment approach: starting with trastuzumab deruxtecan (induction treatment), followed by Phesgo (containing trastuzumab and pertuzumab) as maintenance therapy. The study aims to determine effectiveness in preventing cancer progression.

Main inclusion criteria: Patients must understand the study purpose and sign written consent before procedures begin. They should not have received prior chemotherapy or HER2-targeted therapy for advanced disease, though one prior line of hormone therapy is allowed. Previous chemotherapy or HER2-targeted therapy is permitted if there was at least a 12-month gap before metastatic disease diagnosis. Patients need adequate bone marrow and organ function with specific laboratory test results. Side effects from previous treatments must have resolved to a mild level (except hair loss or other non-risky effects). Women of childbearing potential need a negative pregnancy test and must use effective birth control during the study and for 7 months after. Men must use birth control during the study and for 4 months after the last dose. Patients must be 18 years or older with ECOG performance status of 0-1, life expectancy of at least 12 weeks, and HER2-positive tumor overexpression confirmed by central lab. They need known ER and PgR status, unresectable locally recurrent or metastatic disease confirmed by CT or MRI, measurable disease according to RECIST v.1.1 criteria, and must provide a recent tumor tissue sample.

Main exclusion criteria: Patients who have already received chemotherapy or HER2-targeted therapy for advanced breast cancer, those with resectable cancer, patients with cancer that has not spread beyond the local area or returned after treatment, and those not within the specified age range are excluded. Patients not part of the vulnerable population selected for the study are also excluded.

Study focus: The induction phase involves trastuzumab deruxtecan given intravenously, followed by maintenance therapy with Phesgo (containing trastuzumab and pertuzumab) administered subcutaneously or intravenously. Regular monitoring includes health assessments, imaging tests, and laboratory assessments throughout the trial.

Investigational drugs: Trastuzumab deruxtecan (T-DXd) is used as initial treatment, targeting HER2 protein on cancer cells to stop their growth. PHESGO is a combination of trastuzumab and pertuzumab used as maintenance therapy after initial treatment to help keep cancer from returning or growing.

Study on Trastuzumab Emtansine, Pertuzumab, and Atezolizumab for Patients with HER2-Positive Metastatic Cancer Who Benefited from Previous Treatment

This extension trial provides continued treatment to patients who previously benefited from trastuzumab emtansine in earlier studies. The study gathers information on the safety of long-term use, whether used alone or with other medications.

Main inclusion criteria: Patients must have completed or be continuing treatment with trastuzumab emtansine in a previous study, or be in the control group of a specific study at closure. They need adequate organ function shown by specific lab results within 7 days before starting, including proper neutrophil count, platelet count, bilirubin, liver enzymes, and creatinine levels. The doctor must expect the patient may continue to benefit from more treatment. Left ventricular ejection fraction (LVEF) must be 40% or higher measured within 30 days before joining. ECOG Performance Status should be 0-2, meaning the disease does not significantly affect daily living abilities. Women of childbearing potential and men with partners who can have children must agree to use highly effective non-hormonal birth control during treatment and for a specified period after the last dose. Women must not donate eggs, and men must not donate sperm during this time.

Main exclusion criteria: Patients without HER2-positive metastatic cancer, those who did not benefit from previous trastuzumab emtansine treatment, patients not part of the Genentech/Roche-sponsored study, those not in the specified age range, and those part of a vulnerable population are excluded.

Study focus: The trial administers trastuzumab emtansine as a single agent or in combination with other anti-cancer therapies through intravenous infusion. Regular monitoring tracks response to treatment and side effects. Safety data is collected to understand long-term effects.

Investigational drug: Trastuzumab emtansine is an antibody-drug conjugate that combines a HER2-targeted antibody with a chemotherapy drug, delivering treatment directly to cancer cells with high HER2 protein levels to slow or stop cancer growth.

## Summary

Summary

This overview covers 37 ongoing clinical trials for HER2 positive breast cancer across multiple European countries, with notable concentrations in Germany, Italy, France, and Spain. The trials represent diverse treatment approaches at various disease stages, from early-stage to metastatic disease.

A significant focus of current research centers on trastuzumab deruxtecan, which appears in multiple trials either as monotherapy or in combination with other agents. Several studies compare it directly with trastuzumab emtansine or standard chemotherapy regimens, indicating the medical community’s interest in establishing its optimal role in treatment algorithms.

Brain metastases receive particular attention, with dedicated trials evaluating both trastuzumab deruxtecan and tucatinib-based combinations for patients with central nervous system involvement. This reflects growing recognition of the need for treatments that can cross the blood-brain barrier effectively.

Several trials explore chemotherapy-free approaches, combining targeted HER2 therapies with immunotherapy or endocrine therapy. These studies aim to reduce treatment-related side effects while maintaining effectiveness, potentially improving patients’ quality of life.

The trials also address practical clinical questions, such as optimal treatment duration, response-adapted strategies using advanced imaging techniques, and methods to manage treatment-related side effects like diarrhea. Some studies focus on specific patient populations, including those with residual disease after initial therapy or molecular markers indicating high recurrence risk.

Geographic distribution shows broad European participation, with countries like Germany, France, Italy, and Spain hosting the most trials. This widespread involvement should facilitate patient access to innovative treatments across the continent. The trials collectively represent comprehensive efforts to improve outcomes for patients with HER2 positive breast cancer through personalized, targeted approaches.

Ongoing Clinical Trials on HER2 positive breast cancer

  • Study of Pertuzumab and Trastuzumab for Patients with Solid Malignant Tumors from Previous Pertuzumab Trials

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Portugal Spain

  • Study on the Effectiveness and Safety of Trastuzumab, Tucatinib, and Vinorelbine for Patients with Advanced HER2-Positive Breast Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Ipatasertib with Trastuzumab and Pertuzumab for Patients with Advanced HER2-Positive Breast Cancer and PIK3CA Mutation

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Trastuzumab and Pertuzumab for Patients with HER2-Positive Breast Cancer Using a Response-Adapted Strategy

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Portugal Spain

  • Study on Time Savings with Subcutaneous Pertuzumab and Trastuzumab for Patients with HER2-Positive Early Breast Cancer

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Giredestrant Combined with Pertuzumab-Trastuzumab (Phesgo) for Patients with Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally Advanced or Metastatic Breast Cancer

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy Poland +2

  • Study of Trastuzumab Deruxtecan for Patients with HER2-Positive Metastatic Breast Cancer Resistant to Trastuzumab, Pertuzumab, and Taxane Treatment

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Alpelisib, Trastuzumab, and Fulvestrant for Patients with PIK3CA Mutated HER2+ Advanced Breast Cancer Previously Treated with Trastuzumab

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

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