In short
There is currently 1 ongoing clinical trial for invasive lobular breast carcinoma, testing a combination of targeted therapies aimed at stopping cancer cell growth in high-risk patients. This trial is being conducted in Germany and focuses on postmenopausal women with hormone receptor-positive, HER2-negative disease.
Clinical trial locations
Study of Capivasertib and Fulvestrant for Patients with High-Risk Lobular Breast Cancer
This trial is investigating the effectiveness of two medications in treating primary high-risk lobular breast cancer: fulvestrant, an injection solution, and capivasertib, an oral tablet. The treatment period lasts approximately 10 weeks, during which researchers will closely monitor how well these medications work to stop cancer cell growth.
Main inclusion criteria:
- Postmenopausal women aged 60 or older, or younger than 60 but without menstrual periods for at least 12 months
- Untreated lobular breast cancer confirmed as HER2-negative and hormone receptor-positive
- High risk of cancer recurrence based on tumor size and lymph node involvement
- No signs of cancer spreading to distant parts of the body
- Good overall health status, able to carry out normal daily activities or light work
- Normal heart function and adequate blood counts
- Liver and kidney function within acceptable ranges
- Blood sugar control with HbA1c less than 8.0%
- Ability to provide tumor tissue samples taken before treatment
- Life expectancy of at least 5 years
Main exclusion criteria:
- Patients without primary high-risk lobular breast cancer
- Male patients
- Children, teenagers, and young adults outside the specified age range
- Vulnerable populations who may have difficulty understanding the study or making informed decisions
Focus and goals: The primary goal is to determine whether these treatments can reduce the activity of a protein called Ki67 to less than 2.7%, which indicates complete cell cycle arrest and means cancer cells have stopped dividing. This will be assessed by examining breast tissue samples. Secondary goals include evaluating whether treatment eliminates all remaining cancer cells in the breast and lymph nodes, measuring how long participants remain free from invasive disease, and tracking overall survival rates.
Investigational drugs: Capivasertib is an oral medication that works by targeting specific proteins involved in cell growth and division, particularly the AKT pathway. It is designed to enhance the effects of fulvestrant. Fulvestrant is an established breast cancer treatment given as an intramuscular injection. It works by blocking and breaking down estrogen receptors, which can slow or stop the growth of cancer cells that depend on estrogen to grow. Participants will receive either fulvestrant alone or the combination of fulvestrant and capivasertib.
Throughout the trial, patients will be monitored regularly to assess how their cancer responds to treatment. The study is expected to conclude by October 2026, and results will help determine whether this treatment approach is effective for managing high-risk lobular breast cancer.
Summary
Currently, there is one active clinical trial for invasive lobular breast carcinoma, located in Germany. This trial specifically targets postmenopausal women with high-risk, hormone receptor-positive, HER2-negative disease. The study focuses on combining capivasertib, a newer targeted therapy that inhibits the AKT pathway, with fulvestrant, an established hormonal treatment. This approach represents an effort to improve outcomes for patients with this particular subtype of breast cancer, which can be more difficult to detect and may have different characteristics compared to other breast cancers. The trial's emphasis on achieving complete cell cycle arrest and eliminating residual cancer cells reflects a goal of preventing recurrence in high-risk patients.
