Ongoing Clinical Trials for Breast Cancer Stage II
There are currently 4 ongoing clinical trials for breast cancer stage II. These studies are testing different treatment combinations and approaches, primarily focusing on HER2-positive and triple-negative breast cancers. The trials are being conducted across several European countries including Germany, Spain, Austria, France, Ireland, Belgium, the Netherlands, and Sweden.
Clinical trial locations
- Austria
- Belgium
- France
- Germany
- Ireland
- Netherlands
- Spain
- Sweden
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, a type that does not have estrogen receptors, progesterone receptors, or excess HER2 protein. The study is testing two treatment approaches: using sacituzumab govitecan alone or combining it with pembrolizumab.
Inclusion criteria: Patients must have triple-negative breast cancer that is ER and PR negative or low positive (10% or fewer positive cells) and HER2 negative. They must be at least 18 years old and willing to follow the study requirements. Important laboratory requirements include adequate blood cell counts, with white blood cells at least 3.5 x 10⁹/L, neutrophils more than 1.5 x 10⁹/L, and platelets at least 100 x 10⁹/L. Liver enzymes must be within acceptable limits, and heart function must be normal as measured by echocardiography. Women of childbearing potential must use effective contraception during the study and for 7 months after the last dose, and must not be pregnant or breastfeeding.
Exclusion criteria: Patients cannot have medical conditions other than triple-negative early breast cancer with low risk for recurrence. Those who do not meet the specific age range or gender requirements, or who are considered part of a vulnerable population, cannot participate.
Focus: The trial aims to determine whether combining sacituzumab govitecan with pembrolizumab is more effective than using sacituzumab govitecan alone. Doctors will monitor patients for the complete absence of cancer in the breast and lymph nodes, and will track participants’ health over three years to see if the cancer stays away. The study will last up to 18 months of active treatment.
Investigational drugs: Sacituzumab govitecan is an antibody-drug conjugate that combines an antibody with a chemotherapy drug. The antibody helps the medication find and attach to cancer cells, while the chemotherapy component works to kill these cells. Pembrolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells more effectively.
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 designed for patients with HER2-negative breast cancer who still have residual disease after receiving standard chemotherapy before surgery and are at high risk of the cancer returning. The trial is being conducted across multiple European countries including Germany, Spain, Austria, France, Ireland, and Belgium.
Inclusion criteria: Participants must be at least 18 years old and agree to use effective birth control methods during treatment. They must have HER2-negative breast cancer confirmed by tissue examination, with remaining cancer tissue after initial chemotherapy treatment. Patients must have undergone proper surgical removal of the cancer and lymph nodes and completed at least 16 weeks of chemotherapy containing taxane. They must start the study within 16 weeks after final surgery or within 10 weeks after completing radiation therapy, and must have good physical function with an ECOG score of 0 or 1. Normal heart function and acceptable blood test results are required.
Exclusion criteria: Patients with previous HER2-positive breast cancer diagnosis, active or untreated brain metastases, severe heart conditions, ongoing serious infections, or previous treatment with sacituzumab govitecan cannot participate. Pregnant or breastfeeding women, those with significant liver or kidney dysfunction, uncontrolled high blood pressure, or active autoimmune disease are also excluded. Patients with a history of other cancers within the past 3 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ) are not eligible.
Focus: The study compares sacituzumab govitecan with standard treatment options chosen by the doctor, which may include carboplatin, cisplatin, or capecitabine. Treatment will continue for up to 24 months. The medications are given either through intravenous infusion or as tablets taken by mouth, depending on which treatment the patient receives. The main goal is to determine if sacituzumab govitecan is more effective at preventing cancer recurrence compared to standard treatments.
Investigational drugs: Sacituzumab govitecan is an antibody-drug conjugate that targets cancer cells. The antibody component targets a protein called Trop-2, which is often found on cancer cells, delivering a chemotherapy agent directly to the tumor. The comparison treatments include standard chemotherapy options that doctors typically prescribe for this type of cancer.
Study of Trastuzumab, Pertuzumab, and Chemotherapy Combination with Response-Guided Treatment for Patients with HER2-Positive Breast Cancer
This trial, conducted in the Netherlands, focuses on patients with HER2-positive breast cancer. The research evaluates whether reducing chemotherapy guided by imaging can be effective when combined with two medications that target HER2: trastuzumab (Herceptin) and pertuzumab (Perjeta).
Inclusion criteria: Patients must have confirmed breast cancer that has spread into surrounding breast tissue and be at least 18 years old. They must have stage II or III breast cancer with a tumor that tests positive for HER2. The tumor must be visible on MRI with contrast dye and/or have affected lymph nodes. Patients must be able to perform daily activities with minimal limitations (WHO performance status of 0 or 1) and have adequate blood test results showing healthy bone marrow, normal liver and kidney function. Good heart function is essential, with a heart ejection fraction of 50% or higher. Women of childbearing potential must agree to use effective birth control during treatment and for 7 months after the last dose, and must have a negative pregnancy test.
Exclusion criteria: Patients with metastatic breast cancer or who have received previous chemotherapy or targeted therapy for breast cancer cannot participate. Those with known severe allergic reactions to the study medications, significant heart problems, poorly controlled high blood pressure, pregnancy, breastfeeding, active or uncontrolled serious infections, or other active cancers in the past 5 years are excluded. Serious medical or mental health conditions that could interfere with study participation also prevent enrollment.
Focus: The treatment plan includes paclitaxel and carboplatin as chemotherapy drugs, along with trastuzumab and pertuzumab which target cancer cells. Some patients may also receive trastuzumab emtansine (Kadcyla), which combines trastuzumab with another anti-cancer substance. Throughout the study, doctors will use imaging tests to monitor treatment effectiveness and may adjust the amount of chemotherapy given based on these results. Patients will be monitored for at least three years after starting treatment.
Investigational drugs: Trastuzumab is a targeted therapy that attaches to HER2 proteins on cancer cells, helping to stop them from growing and dividing. Pertuzumab works differently by preventing HER2 proteins from pairing with other HER2 proteins. When used together as dual HER2-blockade therapy, they work in combination to more effectively target and treat HER2-positive cancer cells.
Study on Preoperative Treatment for HER2 Positive Breast Cancer Using Docetaxel, Pertuzumab, and Trastuzumab in Patients with Primary Breast Cancer
This Swedish trial evaluates a treatment approach guided by patient response to therapy for HER2-positive breast cancer. The study uses docetaxel, pertuzumab (Perjeta), trastuzumab (Herceptin), and trastuzumab emtansine (Kadcyla) to see how well they work in shrinking the cancer before surgery.
Inclusion criteria: Participants must provide written informed consent and be 18 years or older. They must have breast cancer confirmed by histology with tests for ER, PR, HER2, and a proliferation marker. Tumor and blood samples must be available, with HER2 type confirmed by Next-Generation Sequencing. Patients must have primary breast cancer larger than 20mm in diameter or confirmed cancer spread to the lymph nodes. Adequate bone marrow, kidney, liver, and heart functions are required, with a Left Ventricular Ejection Fraction greater than 55%. An ECOG performance status of 0-1 is necessary, meaning patients are fully active or have some symptoms but can carry out light work.
Exclusion criteria: Patients with any other type of cancer besides primary breast cancer cannot participate. Those not within the specified age range or clinical trial groups are excluded. The study is open to both women and men, but individuals considered part of a vulnerable population are not eligible.
Focus: The study monitors how the cancer responds to treatments and assesses long-term outcomes. It evaluates the effectiveness of treatment in reducing tumor size and improving the chances of successful surgery. Various aspects such as clinical and radiological response, tumor characteristics, survival rates, frequency of breast-conserving surgeries, and overall safety of the treatment regimen will be assessed.
Investigational drugs: Trastuzumab targets the HER2 protein on cancer cells, helping to stop their growth and spread. Pertuzumab blocks the HER2 protein in a different way and is often used in combination with trastuzumab to enhance the treatment effect. Docetaxel is a chemotherapy drug that kills cancer cells by interfering with their ability to divide and grow. Paclitaxel and carboplatin are additional chemotherapy medications used in combination with other treatments to improve outcomes.
Summary
The four ongoing clinical trials for breast cancer stage II demonstrate diverse treatment approaches targeting different cancer subtypes. Two trials focus on HER2-positive breast cancer, testing combinations of trastuzumab and pertuzumab with various chemotherapy agents, with studies taking place in the Netherlands and Sweden. Two other trials concentrate on HER2-negative and triple-negative breast cancers, both investigating sacituzumab govitecan either alone or in combination with other therapies.
A notable observation is the concentration of trials in Germany, which participates in two of the four studies. The multi-country trial studying sacituzumab govitecan for HER2-negative breast cancer has the broadest reach, spanning six European countries: Germany, Spain, Austria, France, Ireland, and Belgium. This geographic distribution suggests strong European collaboration in advancing treatment options for different breast cancer subtypes.
Sacituzumab govitecan appears in two trials, indicating significant research interest in this antibody-drug conjugate. Similarly, the combination of trastuzumab and pertuzumab is featured in two studies, reflecting the established importance of dual HER2-blockade therapy. All trials emphasize patient response monitoring and aim to optimize treatment effectiveness while managing side effects, with study durations ranging from 18 months to 3 years of follow-up.
