Recruiting

Study of Capivasertib and Fulvestrant for Patients with High-Risk Lobular Breast Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for primary high-risk lobular breast cancer. The study will evaluate the effectiveness of two medications: Fulvestrant, which is a solution for injection, and Capivasertib, which is a film-coated tablet. Fulvestrant works as a competitive estrogen receptor antagonist, while Capivasertib is a potent and selective oral inhibitor of all three isoforms of the serine/threonine kinase AKT. The purpose of the study is to assess the ability of these treatments to stop the cancer cell cycle completely.

Participants in the study will receive either Fulvestrant alone or a combination of Fulvestrant and Capivasertib. The study will last for approximately 10 weeks, during which the effects of the treatments on the cancer will be closely monitored. The main goal is to see if the treatments can reduce the activity of a protein called Ki67 to less than 2.7%, which indicates a complete cell cycle arrest. This will be assessed by examining breast tissue samples.

Secondary goals of the study include evaluating the absence of any remaining cancer cells in the breast and lymph nodes after treatment, known as a pathological complete response. The study will also look at how long participants remain free from invasive disease and overall survival rates. These outcomes will help determine the effectiveness of the treatments in managing high-risk lobular breast cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will begin the trial with a focus on treating primary high-risk lobular breast cancer.
The study aims to evaluate the effectiveness of two medications: fulvestrant and capivasertib.
Step 2
Medication administration
The patient will receive fulvestrant as a 250 mg solution for injection. This medication is administered intramuscularly.
Additionally, the patient will take capivasertib in the form of film-coated tablets, which are taken orally.
Step 3
Treatment duration
The treatment period is approximately 10 weeks. During this time, the patient will be monitored for the primary endpoint, which is a reduction in the Ki67 marker to less than 2.7%.
Step 4
Monitoring and assessment
Throughout the trial, the patient's response to the treatment will be assessed through various endpoints, including the absence of tumor cells in resected specimens and overall survival.
The study will also evaluate the patient's invasive disease-free survival, which measures the time until any recurrence or new cancer development.
Step 5
Completion of the trial
The trial is expected to conclude by October 15, 2026. The patient's progress and outcomes will be documented and analyzed to determine the effectiveness of the treatment.

Who can join the trial?

23 criteria

The patient must provide written informed consent before starting any specific procedures related to the study. This means they agree to participate and understand what the study involves.
The patient must be able to attend scheduled visits, receive treatment, and participate in follow-up appointments.
The patient must have normal heart function as confirmed by local medical guidelines.
Laboratory tests must show:
- Enough white blood cells, specifically a type called neutrophils, which should be at least 1.5 x 10⁹ per liter.
- Enough platelets, which help with blood clotting, at least 100 x 10⁹ per liter.
- Hemoglobin, a protein in red blood cells, should be at least 10 grams per deciliter.
- Liver function tests should show:
  - Total bilirubin, a substance made by the liver, should be less than 1.25 times the upper limit of normal (ULN).
  - AST and ALT, enzymes that indicate liver health, should be 1.5 times the ULN or less.
  - Alkaline phosphatase, another enzyme, should be 2.5 times the ULN or less.
  - Blood sugar control, measured by HbA1c, should be less than 8.0%.
  - Kidney function should show creatinine, a waste product, less than 1.25 times the ULN or a creatinine clearance of at least 50 ml/min.
  - The patient must complete a full assessment of their cancer before starting treatment, following standard recommendations.
  - The patient must be a postmenopausal woman, which means:
    
    She is 60 years or older, or
    She is under 60 but has not had a menstrual period for at least 12 months for reasons other than pregnancy.
    She has had both ovaries removed.
    A negative pregnancy test is required within 14 days before starting the study for women 50 years or younger who have not had both ovaries removed.
    The patient must have untreated lobular breast cancer, which is a specific type of breast cancer. If cancer is present in both breasts, both must be of the lobular type.
    The patient must be willing and able to provide a sample of their tumor tissue, which was taken before starting treatment.
    The cancer must be confirmed as HER2-negative and HR-positive, which are specific characteristics of the cancer cells. HER2-negative means the cancer does not have high levels of a protein called HER2, and HR-positive means the cancer grows in response to hormones.
    The patient must have a high risk of cancer coming back, defined by specific tumor size and lymph node involvement.
    There must be no signs of cancer spreading to distant parts of the body.
    The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
    The patient should have an estimated life expectancy of at least 5 years, regardless of their breast cancer diagnosis.

Who cannot join the trial?

4 criteria

Patients who do not have primary high-risk lobular breast cancer cannot participate. This type of cancer starts in the lobules, which are the glands that produce milk in the breast, and is considered high-risk due to its potential to spread or grow quickly.
Only females are eligible to participate, so males cannot join the study.
Participants must be within certain age ranges, specifically adults and older adults. This means children and teenagers are not eligible.
Individuals who are part of a vulnerable population, such as those who might have difficulty understanding the study or making decisions, are not included.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Charite Universitaetsmedizin Berlin KöR
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Berlin, Germany
Goethe University Frankfurt
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Frankfurt, Germany
Institut fuer Diabetesforschung Muenster GmbH
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Munster, Germany

Trial locations

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Investigated drugs

Capivasertib
is a medication being studied for its potential to help stop the growth of cancer cells. It works by targeting specific proteins that are involved in the cell cycle, which is the process that controls cell division and growth. In this trial, capivasertib is being tested to see if it can enhance the effects of another medication, fulvestrant, in treating high-risk lobular breast cancer.
Fulvestrant
is a medication used to treat certain types of breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. In this study, fulvestrant is being used alone and in combination with capivasertib to evaluate its effectiveness in stopping cancer cell growth in patients with high-risk lobular breast cancer.

What is already known about the treatment

Capivasertib
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating primary high-risk lobular breast cancer. It is not yet widely used in standard medical practice but shows promise in ongoing research. Capivasertib works by inhibiting specific enzymes involved in cell growth, which may help stop cancer cells from multiplying. It is classified as a kinase inhibitor, targeting pathways that are crucial for cancer cell survival.
Fulvestrant
This medication is given as an injection and is used in the treatment of certain types of breast cancer, including primary high-risk lobular breast cancer. It is well-established in medical literature and is commonly used in clinical settings. Fulvestrant works by blocking and degrading estrogen receptors, which can slow or stop the growth of cancer cells that rely on estrogen. It is classified as an estrogen receptor antagonist.

Investigated diseases

Primary High-Risk Lobular Breast Cancer – This is a type of breast cancer that originates in the lobules, which are the glands responsible for milk production. It is characterized by cancer cells that invade surrounding breast tissue and potentially spread to other parts of the body. Lobular breast cancer is often more difficult to detect on mammograms compared to other types of breast cancer due to its growth pattern. The term "high-risk" indicates that the cancer has features that may lead to a more aggressive progression. This type of cancer may not form a distinct lump, making it challenging to diagnose early. It is important to monitor for changes in breast texture or appearance, as these can be subtle indicators of the disease.