Ongoing Clinical Trials for Breast Cancer in Male Patients
There are currently 5 ongoing clinical trials for male breast cancer patients across several European countries. These studies are testing new treatment combinations and targeted therapies for different types and stages of breast cancer, including triple-negative breast cancer, HER2-negative breast cancer, and HER2-positive breast cancer. The trials are being conducted in Germany, France, Spain, Belgium, Austria, Ireland, and Sweden.
Clinical trial locations
- Austria
- Belgium
- France
- Germany
- Study Comparing Sacituzumab Govitecan Alone and with Pembrolizumab for Patients with Low-Risk, Triple-Negative Early 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
- Ireland
- Spain
- Sweden
Study Comparing Sacituzumab Govitecan Alone and with Pembrolizumab for Patients with Low-Risk, Triple-Negative Early Breast Cancer
This trial is testing treatment options for triple-negative early breast cancer, a type that lacks certain hormone receptors and the HER2 protein. The study compares sacituzumab govitecan used alone versus in combination with pembrolizumab.
Main inclusion criteria: Participants must have triple-negative early breast cancer with ER and PR negative or low positive (10% or fewer positive cells) and HER2 negative status. They must be at least 18 years old and have adequate organ function. Laboratory requirements include specific levels for white blood cells, neutrophils, platelets, hemoglobin, liver enzymes, and kidney function. Heart function must be normal, and women of childbearing potential must use effective contraception and have a negative pregnancy test.
Main exclusion criteria: Patients with other medical conditions beyond the specified type of breast cancer cannot participate. Those who don’t meet age, gender, or vulnerability criteria are excluded.
Trial focus: The study aims to determine whether combining sacituzumab govitecan with pembrolizumab is more effective than sacituzumab govitecan alone. Treatment is given through intravenous infusion over up to 18 months. Researchers will monitor for complete response in the breast and lymph nodes and track participants’ health over three years to assess if the cancer remains absent.
Investigational drugs: Sacituzumab govitecan is an antibody-drug conjugate that targets cancer cells, while pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells.
Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
This trial is evaluating DS-3939a, a new medication for advanced solid tumors that have spread beyond their original location. The study includes various cancer types, including breast cancer.
Main inclusion criteria: Participants must have advanced or metastatic solid tumors with measurable disease based on RECIST V1.1 criteria. They must have adequate organ function and a left ventricular ejection fraction of at least 50%. Performance status must be ECOG 0-1. For Part 1, patients with various cancers including breast are eligible. For Part 2, patients must have disease progression and be able to provide a baseline tumor sample.
Main exclusion criteria: Patients with metastatic or advanced solid tumors outside the study specifications, those not meeting age requirements, vulnerable populations, and those who don’t meet safety and tolerability requirements for DS-3939a are excluded.
Trial focus: The study is divided into two parts. Part 1 assesses the safety and tolerability of DS-3939a, while Part 2 continues safety evaluation and measures treatment effectiveness at a recommended dose. Throughout the trial, participants receive close monitoring including regular check-ups, laboratory tests, and imaging studies.
Investigational drug: DS-3939a is administered as an intravenous infusion and is designed to help treat advanced solid tumors by targeting specific pathways that cancer cells use to grow and spread.
Study of Pembrolizumab and Olaparib for Patients with Advanced HER2 Negative Breast Cancer and Specific Genetic Mutations
This trial focuses on HER2-negative breast cancer that cannot be surgically removed or has spread to other parts of the body. Participants must have specific genetic mutations in genes such as BRCA1, BRCA2, or other related genes, or have homologous recombination deficiency.
Main inclusion criteria: Participants must have histologically confirmed metastatic or advanced, unresectable HER2-negative breast cancer. They must have specific genetic mutations in BRCA or related genes, or high HRD status. Measurable disease based on RECIST v1.1 is required, along with ECOG performance status of 0-1. Female participants must have a negative pregnancy test, and all participants must agree to use effective birth control. Patients with hormone receptor positive cancer must have previously tried CDK4/6 inhibitors with endocrine treatment.
Main exclusion criteria: Patients without unresectable or metastatic HER2-negative breast cancer, those without deleterious germline mutations in specific genes, and those without homologous recombination deficiency are excluded.
Trial focus: The study tests the combination of pembrolizumab and olaparib over a 27-week treatment period. Researchers will monitor how well the cancer responds to treatment, how long the response lasts, and overall survival without disease progression. Regular monitoring includes physical exams, blood tests, and imaging scans.
Investigational drugs: Pembrolizumab is an immunotherapy given by infusion that helps the immune system fight cancer cells. Olaparib is taken orally and works by preventing cancer cells with certain genetic mutations from repairing themselves.
Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
This study is for patients with HER2-negative breast cancer who still have residual disease after receiving standard neoadjuvant chemotherapy and are at high risk of cancer returning.
Main inclusion criteria: Participants must be at least 18 years old. They must have HER2-negative breast cancer with remaining cancer tissue after at least 16 weeks of taxane-containing chemotherapy, with specific risk factors for cancer return. Proper surgical removal of cancer and lymph nodes must have been completed. Participants must start the study within 16 weeks after final surgery or within 10 weeks after completing radiation therapy. Good physical function (ECOG 0-1), normal heart function, and acceptable blood test results are required. Effective birth control must be used, and participants must have a negative pregnancy test if applicable.
Main exclusion criteria: Previous HER2-positive breast cancer diagnosis, age below 18, pregnancy or breastfeeding, active or untreated brain metastases, severe heart conditions, serious infections, previous treatment with sacituzumab govitecan, known allergies to study medications, significant liver or kidney dysfunction, uncontrolled high blood pressure, active autoimmune disease, and recent history of other cancers are all grounds for exclusion.
Trial focus: The study compares sacituzumab govitecan to standard treatments chosen by the doctor from options including carboplatin, cisplatin, or capecitabine. Treatment continues for up to 24 months to determine if sacituzumab govitecan is more effective at preventing cancer recurrence. Regular monitoring tracks for disease return and quality of life.
Investigational drugs: Sacituzumab govitecan is an antibody-drug conjugate that combines an antibody targeting cancer cells with a chemotherapy drug. Standard treatment options include carboplatin, cisplatin (given by infusion), or capecitabine (taken as tablets).
Study on Preoperative Treatment for HER2 Positive Breast Cancer Using Docetaxel, Pertuzumab, and Trastuzumab in Patients with Primary Breast Cancer
This trial studies HER2-positive breast cancer, characterized by overexpression of the HER2 protein. The study evaluates a response-guided treatment approach before surgery.
Main inclusion criteria: Participants must be 18 years or older and provide written informed consent. They must have histologically confirmed breast cancer with ER, PR, HER2, and proliferation marker testing. Primary breast cancer must be larger than 20mm in diameter or have confirmed lymph node involvement. Adequate bone marrow, kidney, liver, and heart functions are required, with left ventricular ejection fraction greater than 55%. ECOG performance status must be 0-1. Tumor and blood samples must be available for testing.
Main exclusion criteria: Patients with any other type of cancer besides primary breast cancer, those outside the specified age range, individuals not meeting clinical trial group specifications, and vulnerable populations are excluded.
Trial focus: The study evaluates preoperative treatment using docetaxel, pertuzumab (Perjeta), trastuzumab (Herceptin), and trastuzumab emtansine (Kadcyla). Treatment is given through infusions or injections to shrink cancer before surgery. The study monitors clinical and radiological response, tumor characteristics, survival rates, and frequency of breast-conserving surgeries. Regular assessments track treatment effectiveness and safety.
Investigational drugs: Trastuzumab and pertuzumab target the HER2 protein to stop cancer cell growth. Docetaxel and paclitaxel are chemotherapy drugs that interfere with cancer cell division. Carboplatin is a chemotherapy drug that damages cancer cell DNA.
Summary
These five clinical trials offer diverse treatment options for male breast cancer patients across Europe, with particularly strong representation in Germany, which hosts three of the five trials. The studies focus on three main categories: triple-negative breast cancer, HER2-negative breast cancer, and HER2-positive breast cancer.
A notable trend is the frequent use of sacituzumab govitecan, which appears in three trials either alone or in combination with other medications. This antibody-drug conjugate represents a promising targeted therapy approach. Immunotherapy with pembrolizumab is being evaluated in two studies, reflecting growing interest in harnessing the immune system to fight cancer.
The trials vary in their approach, with some focusing on early-stage disease with low risk of recurrence, while others target advanced or metastatic cancer. Several studies emphasize personalized treatment based on genetic mutations, particularly BRCA1/2 and related genes, highlighting the increasing importance of precision medicine in cancer care.
Geographic distribution shows that larger European countries with established cancer research infrastructure are leading these investigations, though participation opportunities exist across multiple nations. Treatment durations range from several months to over two years, with all studies incorporating comprehensive safety monitoring and quality of life assessments.
