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Hormone receptor positive HER2 negative breast cancer – Trials in Disease

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Clinical Trials for Hormone Receptor Positive HER2 Negative Breast Cancer

There are currently 33 ongoing clinical trials studying new treatments for hormone receptor positive HER2 negative breast cancer. These trials are testing various medications including targeted therapies, immunotherapies, and hormone treatments, with studies taking place across multiple countries in Europe and beyond.

Clinical trial locations

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

This trial is studying a new treatment called DB-1303 for patients with metastatic breast cancer that is hormone receptor positive and has low levels of the HER2 protein. The study compares DB-1303 with standard chemotherapy options to see which works better at slowing cancer progression.

Main inclusion criteria: Patients must be adults aged 18 or older with good organ and bone marrow function. The cancer must be advanced or metastatic, hormone receptor positive, and HER2-low. Patients should have received prior hormone therapy and a CDK4/6 inhibitor, with disease progression occurring within specific timeframes. At least one measurable tumor must be present.

Main exclusion criteria: Patients who have received more than one prior chemotherapy or antibody-drug conjugate treatment for metastatic disease are excluded. Those whose cancer is not resistant to hormone therapy and CDK4/6 inhibitors cannot participate.

Trial focus: The study aims to evaluate whether DB-1303 is more effective than standard chemotherapy in extending the time before cancer progression. Participants receive either DB-1303 through intravenous infusion or one of several chemotherapy drugs. Throughout the trial, patients are closely monitored through regular assessments and imaging studies to track treatment response and side effects.

Investigational drug: DB-1303 is an experimental antibody-drug conjugate being tested for its effectiveness against HER2-low, hormone receptor-positive metastatic breast cancer. It works by targeting the HER2 protein on cancer cells and delivering a toxic substance directly to them.

Study Comparing Elacestrant and Standard Endocrine Therapy for Patients with Early Breast Cancer at High Risk of Recurrence

This study is evaluating a medication called elacestrant compared to standard hormone therapies for patients with early-stage breast cancer that has a high risk of returning. The cancer must be hormone receptor positive and HER2 negative.

Main inclusion criteria: Patients must have confirmed node-positive, estrogen receptor-positive, HER2-negative early breast cancer with high recurrence risk. They should have completed surgery and received at least 24 months but no more than 60 months of hormone therapy. Both male and female patients can participate.

Main exclusion criteria: Patients without node-positive disease or those with HER2-positive cancer cannot participate. Those not within the specified age range or treatment duration are also excluded.

Trial focus: The primary goal is to determine whether elacestrant can better prevent cancer recurrence compared to standard hormone therapies. Participants are randomly assigned to receive either elacestrant or standard treatment and are monitored for up to 60 months. The study also assesses quality of life and side effects.

Investigational drug: Elacestrant is a selective estrogen receptor degrader that works by targeting and breaking down estrogen receptors on cancer cells, potentially preventing cancer recurrence more effectively than standard treatments.

Study of BT8009 for Patients with Advanced Breast Cancer with NECTIN4 Amplification

This trial studies zelenectide pevedotin (BT8009) for treating advanced breast cancer characterized by NECTIN4 gene amplification. The medication is being tested to see how effectively it can shrink tumors in this specific patient population.

Main inclusion criteria: Patients must be at least 18 years old with confirmed NECTIN4 amplified advanced breast cancer that is either recurrent, unresectable, or metastatic. The cancer must be measurable according to specific criteria, and patients must have adequate organ function and a life expectancy of at least 12 weeks.

Main exclusion criteria: Patients with prior HER3-targeted therapy, active untreated brain metastases, severe heart conditions, or uncontrolled infections are excluded. Pregnant or breastfeeding women cannot participate.

Trial focus: The study evaluates how well zelenectide pevedotin works in treating this specific type of advanced breast cancer by monitoring tumor response through regular imaging and assessments. The treatment is administered intravenously, and patients are monitored for both effectiveness and side effects.

Investigational drug: Zelenectide pevedotin is an antibody-drug conjugate that delivers a toxic substance directly to cancer cells expressing the NECTIN4 protein, helping to kill these cells while minimizing damage to normal tissue.

Study of Camizestrant for Patients with ER+/HER2- Early Breast Cancer After 2 Years of Standard Endocrine Therapy

This study evaluates whether extended treatment with camizestrant is more effective than continuing standard hormone therapy in preventing breast cancer recurrence in patients who have already completed at least two years of treatment.

Main inclusion criteria: Patients must be adults aged 18 or older with ER-positive, HER2-negative early breast cancer at high or intermediate recurrence risk. They must have completed surgery with clear margins and received at least 2 years but no more than 5 years and 3 months of post-surgical hormone therapy. Adequate organ and bone marrow function is required.

Main exclusion criteria: Patients with different cancer types, those outside the specified treatment duration, or those unable to follow study procedures are excluded.

Trial focus: The trial compares camizestrant to standard hormone therapies over an extended treatment period. Patients are randomly assigned to treatment groups and monitored regularly for cancer recurrence, side effects, and quality of life. The study aims to determine if camizestrant offers superior protection against cancer returning.

Investigational drug: Camizestrant is an oral selective estrogen receptor degrader that works by binding to and degrading estrogen receptors, thereby blocking estrogen-driven cancer cell growth more effectively than traditional hormone therapies.

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

This trial compares two treatment combinations for early breast cancer: elacestrant plus ribociclib versus an aromatase inhibitor plus ribociclib. The study aims to determine which combination is more effective when given before surgery to shrink tumors.

Main inclusion criteria: Patients must be women or men aged 18 or older with confirmed HER2-negative, estrogen receptor-positive breast cancer. The cancer must be suitable for hormone therapy and patients must have adequate organ function. If premenopausal or perimenopausal, patients will also receive hormone suppression therapy.

Main exclusion criteria: Patients with prior treatment using specific hormone therapies or those with other serious health conditions that could interfere with the study are excluded.

Trial focus: The study evaluates tumor response after six months of treatment, using the modified PEPI score measured at surgery. Participants take their assigned medications orally throughout the treatment period and undergo regular monitoring including biopsies and imaging.

Investigational drugs: Elacestrant blocks estrogen receptors while ribociclib inhibits proteins involved in cancer cell division. Aromatase inhibitors reduce estrogen production in the body, all working to slow or stop cancer growth.

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

This study investigates whether giredestrant combined with triptorelin is more effective than anastrozole combined with triptorelin in reducing cancer cell growth before surgery in premenopausal women with hormone-responsive breast cancer.

Main inclusion criteria: Patients must be premenopausal women aged 18 or older with ER-positive, HER2-negative breast cancer suitable for surgery. The tumor must be at least 1 cm in size with a Ki67 level of 10% or higher. Adequate organ function and negative pregnancy tests are required.

Main exclusion criteria: Patients who have already received breast cancer treatment or those with cancer that has spread to other parts of the body cannot participate.

Trial focus: The study measures changes in the Ki-67 index (a marker of cell growth) between initial and post-treatment tumor biopsies. Treatment lasts four weeks before surgery, with patients taking oral medications and receiving hormone suppression injections. The goal is to evaluate which treatment combination better reduces cancer cell proliferation.

Investigational drugs: Giredestrant is a selective estrogen receptor degrader that degrades estrogen receptors. Triptorelin suppresses ovarian function to reduce hormone levels, while anastrozole blocks estrogen production by inhibiting the aromatase enzyme.

Study of Patritumab Deruxtecan and Pembrolizumab for Patients with High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive Breast Cancer

This trial studies the safety and effectiveness of combining patritumab deruxtecan with pembrolizumab and chemotherapy for treating high-risk early-stage breast cancer, including both triple-negative and hormone receptor-low positive types.

Main inclusion criteria: Patients must have locally advanced, non-metastatic breast cancer that is either triple-negative or hormone receptor-low positive with HER2-negative status. They must have adequate heart function with a left ventricular ejection fraction of 50% or higher and an ECOG performance status of 0 or 1. Both female and male patients can participate.

Main exclusion criteria: Patients with severe allergic reactions to study drugs, recent cancer treatment, uncontrolled illnesses, pregnancy, active infections, brain metastases, or autoimmune diseases are excluded.

Trial focus: The study involves multiple treatment phases including neoadjuvant therapy before surgery, followed by surgery, and then additional treatment afterward. The medications are administered through intravenous infusion. Regular monitoring assesses treatment effectiveness and side effects throughout the study period.

Investigational drugs: Patritumab deruxtecan targets the HER3 protein on cancer cells, delivering anti-cancer drugs directly to them. Pembrolizumab is an immunotherapy that helps the immune system recognize and destroy cancer cells by blocking the PD-1 protein.

Study of patritumab deruxtecan versus drug combination in patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer

This study compares patritumab deruxtecan with standard treatment options chosen by physicians for patients with advanced hormone receptor-positive, HER2-negative breast cancer whose disease has progressed despite hormone therapy and CDK4/6 inhibitor treatment.

Main inclusion criteria: Patients must be at least 18 years old with hormone receptor-positive, HER2-negative breast cancer that is locally advanced or metastatic. The cancer must have progressed during or after CDK4/6 inhibitor treatment combined with hormone therapy. Patients must have measurable disease and adequate organ function.

Main exclusion criteria: Prior HER3-targeted therapy, active untreated brain metastases, significant heart conditions, severe liver or kidney problems, and active infections requiring treatment are exclusionary criteria.

Trial focus: Participants are randomly assigned to receive either patritumab deruxtecan or physician’s choice treatment. The study measures how long patients live without cancer progression and monitors overall health status and quality of life. Regular imaging and health assessments track treatment response and side effects.

Investigational drug: Patritumab deruxtecan is an antibody-drug conjugate that targets HER3-expressing cancer cells, delivering a topoisomerase inhibitor payload directly to cancer cells to stop their growth.

Study on Early Detection and Treatment of ER Positive HER2 Negative Breast Cancer Using Palbociclib, Fulvestrant, and Drug Combination for Patients with Molecular Relapse

This trial studies whether detecting cancer recurrence early through blood tests for circulating tumor DNA allows for more effective treatment with palbociclib and fulvestrant compared to continuing standard hormone therapy alone.

Main inclusion criteria: Patients must have ER-positive, HER2-negative early breast cancer and have completed at least two years of standard hormone therapy without recurrence. They must provide consent for tissue and blood sample donation and be willing to undergo frequent blood tests. Both male and female patients can participate.

Main exclusion criteria: Patients with evidence of cancer spread to distant organs, those unable to follow study procedures, pregnant or breastfeeding women, and those with certain medical conditions that could interfere with the study are excluded.

Trial focus: The study involves regular blood monitoring for circulating tumor DNA. If detected, patients may be randomly assigned to receive palbociclib and fulvestrant or continue standard therapy. The goal is to assess whether early intervention with the combination treatment improves outcomes compared to waiting until clinical recurrence.

Investigational drugs: Palbociclib inhibits proteins involved in cancer cell division, while fulvestrant blocks and degrades estrogen receptors on cancer cells, working together to prevent cancer growth.

Study on Ribociclib and Drug Combination for Patients with Advanced HER2-Negative, Hormone Receptor Positive Breast Cancer

This study evaluates the effectiveness and resistance patterns of ribociclib when combined with various hormone therapies in patients with advanced hormone receptor-positive, HER2-negative breast cancer.

Main inclusion criteria: Patients must have advanced breast cancer that is hormone receptor-positive and HER2-negative, confirmed by local laboratory tests. They should be eligible for treatment with ribociclib combined with hormone therapy and have adequate organ and bone marrow function. The cancer must be locally advanced or metastatic and not curable by surgery or radiation.

Main exclusion criteria: Patients who have already received treatment for metastatic disease (except hormone therapy started within 28 days) or those not meeting specific health criteria are excluded.

Trial focus: The study monitors survival rates at 12 months, specifically looking at progression-free survival and overall survival. Participants receive ribociclib combined with hormone therapy options including anastrozole, exemestane, fulvestrant, or letrozole for up to 48 months. Quality of life is assessed using standardized questionnaires.

Investigational drug: Ribociclib is a CDK4/6 inhibitor that works by blocking specific proteins involved in cancer cell division, helping to slow down cancer progression when combined with hormone therapy.

Summary

The clinical trial landscape for hormone receptor positive HER2 negative breast cancer shows significant activity across Europe, with notable concentration in Western European countries including Germany, France, Spain, Italy, and Belgium. Many trials are multinational, reflecting the collaborative nature of cancer research.

The trials demonstrate a clear focus on several therapeutic approaches. CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) feature prominently, often combined with hormone therapies. Selective estrogen receptor degraders (SERDs) such as elacestrant, camizestrant, and giredestrant represent a major area of investigation, being tested both in early and advanced disease settings. Antibody-drug conjugates targeting various proteins (HER3, NECTIN4) are emerging as innovative treatment options.

The trials address different disease stages, from early-stage disease with high recurrence risk to advanced metastatic cancer. Several studies focus on preventing recurrence after initial treatment, while others evaluate treatments for patients whose cancer has progressed despite prior therapies. Some trials specifically target patient populations with certain genetic mutations (PIK3CA, ESR1) or protein expression patterns (HER2-low, NECTIN4 amplification), demonstrating the move toward personalized medicine.

Quality of life considerations are increasingly incorporated into trial designs, with studies addressing treatment-related side effects such as pain, hyperglycemia, and overall well-being. The diversity of trials offers hope for improved treatment options across the spectrum of hormone receptor positive HER2 negative breast cancer.

Ongoing Clinical Trials on Hormone receptor positive HER2 negative breast cancer

  • A Phase I/II Study of GVV858 Alone or in Drug Combination for Patients with Advanced Hormone Receptor‑Positive, HER2‑Negative Breast Cancer

    Recruiting

    1 1 1
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    Czechia Denmark France Germany Italy Spain

  • Study of ribociclib with or without chemotherapy for patients with hormone receptor positive, HER2 negative early breast cancer at intermediate risk

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Spain

  • Study of elacestrant and exemestane treatment for patients with previously treated hormone receptor-positive, HER2-negative metastatic breast cancer with FES-avid lesions

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of patritumab deruxtecan versus drug combination in patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Hungary Italy Poland +1

  • Study of ECI830, ribociclib, and fulvestrant in patients with advanced hormone receptor positive, HER2-negative breast cancer and advanced solid tumors

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Italy Spain

  • Study of PF-07248144 and fulvestrant in adults with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who had progression after CDK4/6 inhibitor therapy

    Recruiting

    1 1 1 1
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    Investigated drugs:
    Belgium Bulgaria Czechia Finland France Germany +8

  • Study of typology-based coaching and education to help patients with early hormone-positive HER2-negative breast cancer manage their treatment with ribociclib

    Recruiting

    1 1 1 1
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    Germany

  • Preoperative Elacestrant and PULSAR Adaptive Radiotherapy for Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Study for Patients with Stage II-III Disease

    Recruiting

    1 1 1
    Investigated diseases:
    Italy

  • Study on the Effects of Ribociclib and Endocrine Therapy for Patients with HR-Positive, HER2-Negative Early Breast Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Portugal

  • Study on the Safety and Effectiveness of Capivasertib and Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer After Hormone Treatment

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany Portugal

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