Clinical Trials for Breast Cancer in Women
This article provides detailed information about 23 ongoing clinical trials focused on breast cancer in women. These trials are investigating various treatment approaches including immunotherapy, targeted therapy, hormone therapy, and chemotherapy combinations. Trials are being conducted across multiple European countries including Germany, Spain, France, Italy, Belgium, Sweden, Portugal, Poland, Hungary, Ireland, Austria, and Romania.
Clinical trial locations
- Austria
- Belgium
- A Study of Oxytocin Nasal Spray to Reduce Psychological Stress in Women Who Have Recovered from Breast Cancer
- Study of Atezolizumab, Pertuzumab, and Trastuzumab for Patients with HER2 Positive Early High-Risk and Locally Advanced Breast Cancer
- Study of Capivasertib and Fulvestrant for Patients with Advanced or Metastatic HR+/HER2- Breast Cancer
- Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
- Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
- Study on Chemotherapy and Hormone Therapy for Women Over 70 with ER-Positive, HER2-Negative Breast Cancer Using Cyclophosphamide and Drug Combination
- Study on the Safety and Effectiveness of Capivasertib and Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer After Hormone Treatment
- France
- Study of Capivasertib and Fulvestrant for Patients with Advanced or Metastatic HR+/HER2- Breast Cancer
- Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
- Study of Giredestrant, Triptorelin, and Anastrozole in Premenopausal Women with ER-Positive/HER2-Negative Early Breast Cancer
- Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
- Study on Chemotherapy and Hormone Therapy for Women Over 70 with ER-Positive, HER2-Negative Breast Cancer Using Cyclophosphamide and Drug Combination
- Study on Infertility Risk from Chemotherapy in Young Breast Cancer Patients Using Follitropin Beta and Follitropin Alfa for Egg/Embryo Preservation
- Germany
- Study Comparing Ribociclib and Endocrine Therapy to Chemotherapy for Patients with Intermediate-Risk HR+/HER2- Early Breast Cancer
- Study Comparing Sacituzumab Govitecan Alone and with Pembrolizumab for Patients with Low-Risk, Triple-Negative Early Breast Cancer
- Study Comparing Trastuzumab Deruxtecan with a Drug Combination for Patients with HER2+ Early Breast Cancer
- Study of Atezolizumab, Pertuzumab, and Trastuzumab for Patients with HER2 Positive Early High-Risk and Locally Advanced Breast Cancer
- Study of Capivasertib and Fulvestrant for Patients with Advanced or Metastatic HR+/HER2- Breast Cancer
- Study of Pembrolizumab and Olaparib for Patients with Advanced HER2 Negative Breast Cancer and Specific Genetic Mutations
- Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
- Study on Abemaciclib with Endocrine Therapy for Patients with HR+/HER2- Early Breast Cancer at Intermediate to High Risk
- Study on Ribociclib and Drug Combination for Patients with Advanced HER2-Negative, Hormone Receptor Positive Breast Cancer
- Study on the Safety and Effectiveness of Capivasertib and Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer After Hormone Treatment
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- Hungary
- Ireland
- Italy
- Study of Atezolizumab, Pertuzumab, and Trastuzumab for Patients with HER2 Positive Early High-Risk and Locally Advanced Breast Cancer
- Study of Azithromycin, Doxycycline, and Sodium Ascorbate for Patients with Early-Stage Breast Cancer
- Study of Capivasertib and Fulvestrant for Patients with Advanced or Metastatic HR+/HER2- Breast Cancer
- Study of Giredestrant, Triptorelin, and Anastrozole in Premenopausal Women with ER-Positive/HER2-Negative Early Breast Cancer
- Study on the Use of Iomeprol in Contrast Enhanced Mammography for Identifying Breast Cancer in Patients with BIRADS 4 or 5 Lesions
- Poland
- Portugal
- Study on the Safety and Effectiveness of Capivasertib and Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer After Hormone Treatment
- Study on zAvatar Test for Treatment Decisions in Relapsed Ovarian Cancer and Metastatic Breast Cancer Using Palbociclib and Drug Combination for Eligible Patients
- Romania
- Spain
- Study of Atezolizumab, Pertuzumab, and Trastuzumab for Patients with HER2 Positive Early High-Risk and Locally Advanced Breast Cancer
- Study of Capivasertib and Fulvestrant for Patients with Advanced or Metastatic HR+/HER2- Breast Cancer
- Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
- Study of Giredestrant, Triptorelin, and Anastrozole in Premenopausal Women with ER-Positive/HER2-Negative Early Breast Cancer
- Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
- Study on Abemaciclib with Endocrine Therapy for Patients with HR+/HER2- Early Breast Cancer at Intermediate to High Risk
- Study to evaluate gadopiclenol-enhanced magnetic resonance imaging for diagnosis in patients with breast cancer
- Sweden
- Monitoring the Effects of Epirubicin, Cyclophosphamide, and Docetaxel in Women with Breast Cancer
- Study of Giredestrant, Triptorelin, and Anastrozole in Premenopausal Women with ER-Positive/HER2-Negative Early Breast Cancer
- Study of personalized tamoxifen dosing (10mg, 20mg, or 40mg daily) compared to standard dose (20mg) in women with breast cancer to improve treatment continuation
- Study on Imaging and Treatment Prediction for Metastatic Breast Cancer Using Gallium (68Ga) Tezatabep Matraxetan and Trastuzumab Deruxtecan
- Study on Preoperative Treatment for HER2 Positive Breast Cancer Using Docetaxel, Pertuzumab, and Trastuzumab in Patients with Primary Breast Cancer
Study Comparing Sacituzumab Govitecan Alone and with Pembrolizumab for Patients with Low-Risk, Triple-Negative Early Breast Cancer
This trial focuses on triple-negative early breast cancer, which lacks the estrogen, progesterone, and HER2 receptors. The study compares sacituzumab govitecan used alone versus combined with pembrolizumab.
Inclusion criteria: Participants must be at least 18 years old with confirmed triple-negative early breast cancer. The cancer must be ER and PR negative or low positive (10% or fewer positive cells) and HER2 negative. Laboratory requirements include normal levels of white blood cells, neutrophils, platelets, hemoglobin, liver enzymes, kidney function, and heart function. Women of childbearing potential must use effective contraception during the study and for 7 months afterward. The tumor must be at clinical stage I or certain stage II conditions with no distant spread.
Exclusion criteria: Patients with other types of cancer, those outside the specified age range, individuals not meeting gender requirements, and vulnerable populations cannot participate.
Main focus: The trial aims to determine whether combining sacituzumab govitecan with pembrolizumab is more effective than using sacituzumab govitecan alone. Treatment lasts up to 18 months, with regular monitoring for complete response and long-term health outcomes over three years.
Investigational drugs: Sacituzumab govitecan is an antibody-drug conjugate that targets cancer cells. Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells more effectively.
Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
This trial investigates DS-3939a for patients with advanced solid tumors, including breast cancer, that have spread beyond their original location. The study is divided into two parts: evaluating safety and measuring effectiveness.
Inclusion criteria: Participants must sign informed consent, have a left ventricular ejection fraction of at least 50%, adequate organ function, and measurable disease based on RECIST V1.1 criteria. They must have an ECOG performance status of 0 or 1. For Part 1, patients need confirmed locally advanced, metastatic, or unresectable cancer. For Part 2, patients need disease progression on scans during or after recent treatment and must provide a baseline tumor sample.
Exclusion criteria: Patients with metastatic or advanced solid tumors not meeting specific criteria, those outside the specified age range, vulnerable populations, and those not meeting safety requirements cannot participate.
Main focus: The trial evaluates the safety, tolerability, and effectiveness of DS-3939a through intravenous infusion. Researchers will monitor drug levels, side effects, and treatment outcomes, including objective response rate and disease control.
Investigational drug: DS-3939a is designed to help treat advanced solid tumors by targeting specific cancer cell pathways, though its exact mechanism is still under investigation.
Study of Giredestrant, Triptorelin, and Anastrozole in Premenopausal Women with ER-Positive/HER2-Negative Early Breast Cancer
This trial studies different hormone therapy combinations for premenopausal women with ER-positive/HER2-negative early breast cancer. The study compares giredestrant combined with triptorelin against anastrozole combined with triptorelin.
Inclusion criteria: Participants must be premenopausal women aged 18 or older with ER-positive/HER2-negative operable breast cancer. The tumor must be at least 1.0 cm and the cancer must not have spread to distant sites. Required features include ER-positive status (at least 1% of cells), HER2-negative status, and Ki-67 level of 10% or more. Participants must have ECOG performance status of 0-1, normal heart rate and blood counts, negative pregnancy test, and must use effective contraception.
Exclusion criteria: Men, patients who are not premenopausal, those without ER-positive/HER2-negative early breast cancer, and vulnerable populations cannot participate.
Main focus: The trial evaluates whether giredestrant plus triptorelin reduces cancer cell growth more effectively than anastrozole plus triptorelin over a four-week period. Researchers will measure changes in Ki-67 index through tumor biopsies before and after treatment.
Investigational drugs: Giredestrant is a selective estrogen receptor degrader taken orally. Triptorelin is a hormone-suppressing injection that reduces estrogen production. Anastrozole is an aromatase inhibitor that lowers estrogen levels in the body.
Study on Ribociclib and Drug Combination for Patients with Advanced HER2-Negative, Hormone Receptor Positive Breast Cancer
This trial studies ribociclib combined with endocrine therapy for patients with advanced HER2-negative, hormone receptor positive breast cancer. The study aims to estimate survival rates and understand treatment resistance.
Inclusion criteria: Participants must provide written informed consent and be eligible for ribociclib with hormone therapy. They must have advanced or first-time metastatic HER2-negative, HR-positive breast cancer that cannot be cured with surgery or radiation. Requirements include QTcF interval less than 450 ms, adequate organ function, and negative pregnancy test for women of childbearing potential.
Exclusion criteria: Patients without advanced HER2-negative/HR-positive breast cancer, those already treated for breast cancer, men, and vulnerable populations cannot participate.
Main focus: The trial monitors progression-free survival and overall survival at 12 months while examining why some patients develop resistance to ribociclib. Treatment continues for up to 48 months with regular health monitoring.
Investigational drug: Ribociclib blocks certain proteins in cancer cells that control growth and division, potentially slowing cancer progression when combined with hormone therapy medications like anastrozole, exemestane, fulvestrant, or letrozole.
Study on zAvatar Test for Treatment Decisions in Relapsed Ovarian Cancer and Metastatic Breast Cancer Using Palbociclib and Drug Combination for Eligible Patients
This trial evaluates whether the zAvatar-test can better predict effective treatments for patients with relapsed ovarian cancer and metastatic breast cancer compared to standard medical practice.
Inclusion criteria: Participants must be women aged 18 or older who can understand study procedures and sign consent. They must have measurable disease according to RECIST 1.1 criteria, confirmed stage IV breast cancer that is HER2-negative, and high amounts of fluid requiring drainage (ascites or malignant pleural effusion). Requirements include ECOG performance status of 0-2, adequate organ function, and being in second line or later treatment for breast cancer.
Exclusion criteria: Men and vulnerable populations cannot participate.
Main focus: The study compares treatments chosen based on the zAvatar-test versus standard care over a maximum of 24 months. Researchers will monitor progression-free survival, overall survival, and treatment response using various medications including palbociclib, capecitabine, niraparib, and others.
Investigational approach: The zAvatar-test is a predictive model that analyzes specific cancer characteristics to determine the most effective treatment, aiming to improve progression-free survival through personalized therapy selection.
Study to evaluate gadopiclenol-enhanced magnetic resonance imaging for diagnosis in patients with breast cancer
This trial investigates how well gadopiclenol-enhanced MRI works for identifying breast cancer before planned surgery.
Inclusion criteria: Participants must be female, aged 18 or older, with either confirmed breast cancer through core needle biopsy or highly suspicious findings on previous imaging (BI-RADS 4C-5). They must be scheduled for preoperative MRI as part of regular diagnostic process and planned for surgical tumor removal. Written informed consent and willingness to have tissue samples examined after surgery are required.
Exclusion criteria: Patients with contraindications to MRI examination (metal implants, pacemakers, severe claustrophobia), allergies to gadolinium-based contrast agents, men, those younger than 18, pregnant or breastfeeding women, patients with severely reduced kidney function, those who had previous breast surgery in the examination area, patients unable to lie still during MRI, those who received chemotherapy or radiation in the past 6 months, and patients unable to provide informed consent cannot participate.
Main focus: The study evaluates gadopiclenol contrast agent injection at 0.5 mmol/mL concentration to enhance MRI imaging. Researchers will compare MRI findings with surgical tissue examination results to determine accuracy in showing breast cancer details.
Investigational drug: Gadopiclenol is a contrast agent injected before MRI to make certain breast tissues more visible, helping doctors better see and evaluate abnormalities and potential cancer areas for accurate diagnosis and surgical planning.
A Study of Oxytocin Nasal Spray to Reduce Psychological Stress in Women Who Have Recovered from Breast Cancer
This trial investigates whether oxytocin nasal spray can help reduce stress levels in women who have completed breast cancer treatment.
Inclusion criteria: Participants must provide voluntary written consent, be between 18 and 65 years old, be female, have been diagnosed with breast cancer (with or without single metastasis except brain), and have completed chemotherapy and/or radiotherapy between 6 months to 6 years before joining. Ongoing hormone therapy or immunotherapy is acceptable. Participants must speak and understand Dutch well enough to complete study tasks.
Exclusion criteria: Those below 18 or above 65 years, men, patients currently undergoing active cancer treatment or with history of other cancers, severe psychiatric conditions, use of medications that could interact with oxytocin, pregnancy or breastfeeding, uncontrolled high blood pressure or heart conditions, history of adverse reactions to oxytocin, participation in other trials within 30 days, inability to provide consent, and substance abuse within past 6 months cannot participate.
Main focus: Participants receive either oxytocin or placebo nasal spray for up to 5 days. The study measures changes in stress levels, anxiety, depression, and quality of life through questionnaires and computer-based cognitive tasks to determine if oxytocin can help reduce psychological distress.
Investigational drug: Oxytocin is a naturally occurring hormone that may help breast cancer survivors manage psychological stress and reduce emotional distress by influencing social bonding, stress reduction, and emotional well-being.
Monitoring the Effects of Epirubicin, Cyclophosphamide, and Docetaxel in Women with Breast Cancer
This trial monitors the effects of commonly used chemotherapy drugs for breast cancer to understand how they work and how they might be adjusted for individual patients in the future.
Inclusion criteria: Participants must be female, 18 years or older, receiving treatment with cyclophosphamide, epirubicin, doxorubicin, docetaxel, or paclitaxel, and provide written informed consent.
Exclusion criteria: Men, individuals outside the specified age range, those without breast cancer, and vulnerable populations cannot participate.
Main focus: The study measures drug levels in the body and their relationship to side effects and treatment outcomes. Researchers will monitor blood health, liver function, heart health, and overall quality of life. The study explores whether genetic factors influence drug processing to help identify those at risk of receiving too much or too little medication. The goal is to improve treatment by tailoring drug doses to each patient’s needs.
Investigational drugs: Docetaxel, cyclophosphamide, epirubicin, paclitaxel, and doxorubicin are chemotherapy medications given intravenously that work by interfering with cancer cell growth and division, slowing their spread in the body.
Study of Atezolizumab, Pertuzumab, and Trastuzumab for Patients with HER2 Positive Early High-Risk and Locally Advanced Breast Cancer
This trial studies treatments for HER2-positive breast cancer using atezolizumab, pertuzumab, and trastuzumab in combination with chemotherapy.
Inclusion criteria: Participants must be female aged 18 or older with early high-risk or locally advanced and inflammatory breast cancers suitable for pre-surgery treatment. Requirements include confirmed invasive breast cancer in one breast, HER2-positive disease according to current guidelines, known ER and PgR levels, available tumor sample for testing, agreement to provide blood samples at specific times, ECOG performance status of 0 or 1, and written informed consent. Women of childbearing potential must use effective birth control during the study and for at least 7 months after the last dose.
Exclusion criteria: Patients without invasive breast cancer, men, those outside the specified age range, and vulnerable populations cannot participate.
Main focus: The study compares the effectiveness of different treatment combinations in improving 5-year event-free survival. Participants receive medications either intravenously or subcutaneously, with regular health assessments to monitor response and side effects.
Investigational drugs: Atezolizumab blocks a protein that stops the immune system from working properly, allowing it to better target cancer cells. Pertuzumab and trastuzumab target the HER2 protein on cancer cells, stopping their growth and spread.
Study of Azithromycin, Doxycycline, and Sodium Ascorbate for Patients with Early-Stage Breast Cancer
This trial studies whether a short-term antibiotic treatment before surgery can help reduce cancer cell growth in early breast cancer.
Inclusion criteria: Participants must provide written consent, have WHO performance status of 0-1, be able to swallow oral medication, be female over 18 with confirmed invasive breast cancer at AJCC Stage 1-2 or 3, and be scheduled for surgery at least two weeks after joining. Requirements include normal kidney and liver function, diagnostic biopsy, and being within 10% of normal blood test limits. Women of childbearing potential can join but using oral contraceptives, being pregnant, or breastfeeding will exclude them.
Exclusion criteria: Patients without breast cancer, those with more advanced stages, men, vulnerable populations, and those outside the specified age range cannot participate.
Main focus: Participants take azithromycin, doxycycline, and sodium ascorbate orally for up to two weeks before surgery. The study examines changes in cancer cells by comparing samples taken before and after treatment to see if the antibiotics can slow or stop cancer cell multiplication.
Investigational drugs: Doxycycline, amoxicillin, and vancomycin are antibiotics tested to see if they can help reduce breast cancer cell growth before surgery.
Summary
The 23 clinical trials described above represent a diverse range of research approaches for treating breast cancer in women. Several notable patterns emerge from this collection of studies.
Germany leads in the number of trials with involvement in 10 studies, followed by Spain with 7 trials and France with 6 trials. Belgium, Italy, and Sweden each host 5 trials. This concentration of research activity in certain European countries highlights the collaborative nature of breast cancer research across the continent.
The trials investigate various treatment approaches including targeted therapies, immunotherapy, hormone therapy, and chemotherapy combinations. A significant focus exists on HER2-positive and hormone receptor-positive subtypes, with multiple studies examining CDK4/6 inhibitors like ribociclib and abemaciclib combined with endocrine therapy. Several trials explore antibody-drug conjugates such as sacituzumab govitecan and trastuzumab deruxtecan.
The research spans different stages of breast cancer, from early-stage disease to advanced metastatic cancer. Some studies focus on specific populations, including premenopausal women, elderly patients over 70, and young women concerned about fertility preservation. The trials also vary in their approach, with some comparing new treatments to standard chemotherapy while others evaluate personalized treatment strategies.
These trials collectively represent important efforts to improve treatment outcomes, reduce side effects, and enhance quality of life for women with breast cancer across Europe.
