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Hormone receptor positive breast cancer – Trials in Disease

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Ongoing Clinical Trials for Hormone Receptor Positive Breast Cancer

Currently, there are 36 clinical trials investigating new treatments and approaches for hormone receptor positive breast cancer across Europe and other regions. These studies are exploring various therapies including targeted medications, hormone therapies, immunotherapies, and combination treatments aimed at improving outcomes for patients with this type of breast cancer.

Clinical trial locations

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

This trial is investigating DB-1303, an experimental medication administered through intravenous infusion, for patients with HER2-low, hormone receptor positive metastatic breast cancer. The study compares DB-1303 to standard chemotherapy options including capecitabine, paclitaxel, or paclitaxel albumin-bound.

Inclusion criteria: Participants must be adults aged 18 or older with good organ and bone marrow function. The cancer must be measurable with at least one lesion visible on imaging. Patients should have breast cancer that is hormone receptor positive and HER2-low, confirmed by tissue testing. They must have an ECOG performance status of 0 or 1, meaning they can carry out light work despite some symptoms. Previous treatment with hormone therapy and CDK4/6 inhibitors is required, with disease progression on these treatments within 6 months or after at least two lines of hormone therapy. Patients should have a life expectancy of at least 12 weeks and adequate heart function with left ventricular ejection fraction of 50% or higher.

Exclusion criteria: Patients with other types of cancer, serious health conditions that could interfere with treatment, pregnancy or breastfeeding status, recent participation in other trials, known allergies to study medications, and inability to follow study procedures are excluded.

Main focus: The trial aims to evaluate whether DB-1303 can effectively extend the time before cancer progression compared to standard chemotherapy treatments in this specific patient population. Researchers will monitor disease response, survival outcomes, and side effects throughout the study period.

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

This large international trial is comparing giredestrant with physician’s choice of hormone therapy for patients with estrogen receptor-positive, HER2-negative early breast cancer. The study involves patients across 21 European countries and aims to determine which treatment better prevents cancer recurrence.

Inclusion criteria: Participants must have estrogen receptor-positive and HER2-negative early breast cancer that has been completely removed by surgery. The cancer should meet medium or high risk criteria based on tumor characteristics such as size, lymph node involvement, grade, Ki67 levels, Oncotype DX scores, or MammaPrint results. Both patients who received chemotherapy and those who did not are eligible if they meet specific risk criteria. Participants must have documented ER-positive tumor status with at least 1% positive cells and be candidates for at least five years of hormone therapy.

Exclusion criteria: Patients with different breast cancer subtypes that are not ER-positive or HER2-negative cannot participate. The study is open to both genders but has specific age range requirements.

Main focus: The primary goal is to determine whether giredestrant, a selective estrogen receptor degrader, can improve invasive disease-free survival compared to standard endocrine therapies. The study will also assess overall survival, quality of life, and treatment safety over an extended follow-up period.

Study Comparing MK-2870 and Pembrolizumab with Chemotherapy for Patients with Advanced Hormone Receptor Positive Breast Cancer

This trial is testing MK-2870, either alone or combined with pembrolizumab, against physician’s choice chemotherapy for patients with hormone receptor positive breast cancer that cannot be surgically removed. The study is being conducted across 16 European countries.

Inclusion criteria: Participants must have hormone receptor positive breast cancer that is locally advanced or metastatic and cannot be removed by surgery. They should have experienced disease progression on at least one endocrine therapy, with one treatment including a CDK4/6 inhibitor. Patients must be candidates for chemotherapy with an ECOG performance status of 0 to 1. Adequate organ function is required, and patients with well-controlled HIV infection on antiretroviral therapy are eligible if they meet specific viral load and CD4 count criteria.

Exclusion criteria: Patients with other cancer types, those outside the specified age range, vulnerable populations, and those with certain medical contraindications are excluded from participation.

Main focus: The study aims to evaluate whether MK-2870, with or without pembrolizumab, can extend progression-free survival compared to standard chemotherapy. Researchers will also assess overall survival, response rates, safety profiles, and quality of life throughout the treatment period extending up to 12 months.

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

This trial investigates different hormone therapy combinations in premenopausal women with ER-positive/HER2-negative early breast cancer. The study compares giredestrant combined with triptorelin versus anastrozole combined with triptorelin, and also evaluates giredestrant alone.

Inclusion criteria: Participants must be premenopausal women aged 18 or older with operable ER-positive/HER2-negative breast cancer in stage I, II, or operable stage III. The tumor must be at least 1.0 cm in size with at least 1% ER-positive cells and Ki-67 level of 10% or more. Patients must have an ECOG performance status of 0-1 and normal heart rate of at least 40 beats per minute. Multiple tumors in one or both breasts are allowed if all meet the required characteristics. Participants must have normal blood, kidney, and liver function and a negative pregnancy test.

Exclusion criteria: Male patients and those who are not premenopausal are excluded. Patients with ER-negative or HER2-positive breast cancer cannot participate.

Main focus: The trial aims to evaluate changes in Ki-67 index, a marker of cell growth activity, between baseline and post-treatment biopsies after four weeks of treatment. This will help determine if giredestrant combined with triptorelin is more effective than anastrozole combined with triptorelin in reducing cancer cell proliferation.

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

This trial evaluates OP-1250 (palazestrant) as a monotherapy for patients with ER-positive, HER2-negative advanced or metastatic breast cancer who have previously received endocrine therapy and CDK4/6 inhibitor treatment. The study compares OP-1250 to standard hormone therapies across 13 European countries.

Inclusion criteria: Adult participants of both genders must have ER+, HER2- breast cancer that has spread or is locally advanced and cannot be cured. The cancer must be evaluable or measurable. Previous treatment with a CDK4/6 inhibitor plus endocrine therapy is required, with possible additional endocrine therapy alone. Patients should have an ECOG performance status of 0 or 1 and adequate blood, liver, and kidney function. Pre- or peri-menopausal females and males must agree to take GnRH agonist medication.

Exclusion criteria: Patients without the specific cancer type, those outside the age range, and members of vulnerable populations cannot participate.

Main focus: The study aims to determine the safety and effectiveness of OP-1250 compared to standard hormone therapies. Researchers will assess progression-free survival, overall survival at 12 months, and quality of life measures throughout the treatment period of up to 42 days.

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

This trial compares patritumab deruxtecan (MK-1022) with physician’s choice of standard chemotherapy for patients with hormone receptor-positive, HER2-negative breast cancer that has spread or cannot be surgically removed. The study is being conducted across seven European countries.

Inclusion criteria: Participants must be at least 18 years old with confirmed HR+/HER2- advanced or metastatic breast cancer. The cancer must be measurable using standard imaging criteria. Patients should have experienced disease progression on previous hormone therapy combined with CDK4/6 inhibitors. Central laboratory confirmation of HR-positive, HER2-negative status and evaluable HER3 levels from recent tissue samples is required. Participants must have adequate organ function and ECOG performance status of 0 or 1.

Exclusion criteria: Patients with previous HER3-targeted therapy, active brain metastases, significant heart conditions, severe liver or kidney problems, autoimmune conditions requiring systemic treatment, active infections including hepatitis B/C or HIV, pregnancy or breastfeeding, and inability to follow study procedures are excluded.

Main focus: The trial aims to determine whether patritumab deruxtecan can extend progression-free survival and overall survival compared to standard chemotherapy options. Treatment continues until disease progression or unacceptable side effects occur, with the study planned to continue until July 2033.

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

This trial investigates elacestrant for patients with ER-positive/HER2-negative breast cancer who have experienced a relapse detected by circulating tumor DNA testing. The study compares elacestrant combined with standard endocrine therapy to endocrine therapy alone across 11 European countries.

Inclusion criteria: Participants must have ER-positive, HER2-negative early breast cancer with a positive ctDNA test result. Both premenopausal and postmenopausal women, as well as men, can participate if they are at least 18 years old. Patients must have received at least 4.5 to 7 years of endocrine therapy and plan to continue during screening. An elevated risk of recurrence after early breast cancer treatment is required, with no evidence of locoregional or metastatic disease. Participants should have ECOG performance status of 0-1, adequate organ function, and provide tumor tissue samples.

Exclusion criteria: Patients with other cancer types, those not experiencing ctDNA-relapse, and individuals outside the specified age range are excluded. Male patients are excluded from some study groups.

Main focus: The study aims to determine if elacestrant can delay distant metastasis or death in patients with ctDNA-detected relapse. The trial will monitor participants until May 2032, assessing distant metastasis-free survival, overall survival, and safety throughout the treatment period of up to 104 weeks.

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

This trial compares giredestrant combined with a CDK4/6 inhibitor to fulvestrant combined with a CDK4/6 inhibitor for patients with ER-positive, HER2-negative advanced breast cancer that has become resistant to hormone therapy. The study spans 14 European countries.

Inclusion criteria: Participants must have ER-positive, HER2-negative metastatic breast cancer with confirmed ESR1 mutation detected in blood testing. The cancer must show resistance to prior standard hormone therapy, defined as recurrence during or after at least 12 months of treatment. If CDK4/6 inhibitor was previously used, recurrence should occur at least 12 months after stopping. Patients must have measurable disease or bone-only disease and ECOG performance status of 0 or 1. Both female and male participants are eligible.

Exclusion criteria: Patients without ER-positive or HER2-negative cancer, those without ESR1 mutation, and individuals outside specified age ranges are excluded. Members of vulnerable populations may not be eligible.

Main focus: The study evaluates whether giredestrant combined with CDK4/6 inhibitor can improve progression-free survival compared to fulvestrant combined with CDK4/6 inhibitor. The trial will continue until December 2028, monitoring treatment response, safety, and quality of life throughout the study period.

Study on Oxybutynin and Venlafaxine for Reducing Hot Flashes in Women Undergoing Endocrine Therapy After Breast Cancer

This Dutch study (RED FLASH) compares oxybutynin and venlafaxine for managing hot flashes in women receiving endocrine therapy after breast cancer treatment. The crossover study design allows each participant to try both medications.

Inclusion criteria: Participants must be pre-, peri-, or postmenopausal women aged 18 or above currently undergoing endocrine therapy with tamoxifen, aromatase inhibitors, or LHRH analogues for at least 4 weeks. They must experience at least 14 hot flashes per week for a minimum of 1 month and desire medication to manage this symptom.

Exclusion criteria: Men and those with other cancer types cannot participate. Vulnerable populations are not selected for this study.

Main focus: The trial aims to determine which medication is more effective in reducing the frequency and severity of hot flashes during the six-week treatment phases. Participants will maintain daily hot flash diaries and complete questionnaires assessing quality of life, sleep quality, anxiety, depression, cognitive function, and sexual function throughout the study.

Study on Reducing Hormone Therapy Duration with Exemestane, Letrozole, and Anastrozole in Post-Menopausal Women with Low-Risk Hormone-Sensitive Breast Cancer

This French trial investigates whether two years of aromatase inhibitor therapy is sufficient for postmenopausal women with localized luminal A breast cancer at very low risk of metastatic recurrence, compared to the standard five-year treatment duration.

Inclusion criteria: Participants must be postmenopausal women eligible to start or who have recently started hormone therapy with letrozole, anastrozole, or exemestane. They should have completed primary tumor removal and adequate lymph node surgery. The cancer must show at least 50% expression of estrogen or progesterone receptors and be HER2 negative. Patients must be classified as luminal A ultralow risk with less than 5% chance of 10-year recurrence based on MammaPrint and Blueprint testing. ECOG performance status should be 0-1 with a life expectancy of at least 12 months.

Exclusion criteria: Premenopausal women, those with high-risk cancer, non-luminal A breast cancer types, and male patients cannot participate. Vulnerable populations are excluded from this study.

Main focus: The study aims to demonstrate that two years of aromatase inhibitor therapy maintains high 5-year survival rates without distant metastasis in this very low-risk population. The trial will monitor distant metastasis-free survival, invasive disease-free survival, overall survival, and quality of life, with completion expected by March 2034.

Summary

The 36 clinical trials for hormone receptor positive breast cancer demonstrate significant geographic concentration in Western and Central European countries, with France, Germany, Italy, Spain, and Belgium hosting the most studies. Several trials are truly international, spanning 15-20 countries, particularly those investigating newer targeted therapies.

A clear therapeutic focus emerges around CDK4/6 inhibitors combined with hormone therapies, with multiple trials testing abemaciclib, palbociclib, and ribociclib in various settings. Selective estrogen receptor degraders like giredestrant appear frequently across early and advanced disease settings. Novel antibody-drug conjugates such as patritumab deruxtecan and trastuzumab deruxtecan are being evaluated for HER2-low populations, representing an important expansion of treatment options.

The trials address diverse patient populations from early-stage disease through metastatic settings, with particular attention to treatment sequencing after CDK4/6 inhibitor and endocrine therapy progression. Quality of life assessments feature prominently across studies, reflecting growing recognition of treatment tolerability alongside efficacy. Several trials focus on de-escalation strategies, such as shorter hormone therapy duration in low-risk patients or managing treatment-related side effects like hot flashes and diarrhea.

Ongoing Clinical Trials on Hormone receptor positive breast cancer

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

  • Study of elacestrant and ribociclib compared to standard treatment for patients with high-risk ER+/HER2- early breast cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Spain

  • A Study of Camizestrant and Ribociclib for Patients with Hormone Receptor-Positive Breast Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

  • 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
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    Investigated drugs:
    Belgium Germany Portugal

  • Comparing 18F-FDG and 68Ga-FAPI-46 for PET Scans in Patients with Hormone-Positive Breast Cancer

    Recruiting

    1 1 1
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    The Netherlands

  • Study on Oxybutynin and Venlafaxine for Reducing Hot Flashes in Women Undergoing Endocrine Therapy After Breast Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study Comparing MK-2870 and Pembrolizumab with Chemotherapy for Patients with Advanced Hormone Receptor Positive Breast Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark France Germany Greece +10

  • Study on Stopping CDK4/6 Inhibitors in Patients with Metastatic HR Positive, HER2 Negative Breast Cancer Using Abemaciclib, Letrozole, and Fulvestrant

    Recruiting

    1 1 1
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    Investigated drugs:
    Germany

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Elacestrant and Triptorelin for Premenopausal Women with Early Luminal Breast Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

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