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Study on Personalized Treatment for Hormone Receptor Positive HER2 Negative Breast Cancer Using Capivasertib, Letrozole, and Bevacizumab for Eligible Patients

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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 patients with hormone receptor-positive HER2-negative breast cancer. The study involves the use of two main treatments: capivasertib and bevacizumab. Capivasertib, also known by its code name AZD5363, is taken as a tablet, while bevacizumab is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the effectiveness of these treatments in combination with standard endocrine therapy, which is a hormone treatment, and chemotherapy. Initially, participants will receive endocrine therapy with or without capivasertib. After assessing the response to this treatment, some participants may receive chemotherapy with or without bevacizumab, depending on specific molecular characteristics of their cancer. This approach aims to personalize treatment based on the unique features of each patient's cancer.

The study will last for a maximum of 12 months for each participant. During this time, participants will receive the treatments and undergo regular assessments to monitor their response. The goal is to determine how well these treatments work in shrinking the cancer before surgery. This trial is part of ongoing research to improve treatment options for breast cancer patients and to tailor therapies to individual needs.

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
Initial treatment phase
Begin with endocrine therapy which may include the medication capivasertib in combination with letrozole, or letrozole alone. This phase is designed to assess the effect of these treatments on hormone receptor positive, HER2 negative breast cancer.
Capivasertib is administered orally in the form of TRUQAP film-coated tablets. The dosage may vary between 160 mg and 200 mg, depending on the specific treatment plan.
Step 2
Response assessment
After 15 days of therapy, a response evaluation is conducted. This involves a biopsy to measure the Ki67 level, which helps determine the effectiveness of the treatment.
Step 3
Chemotherapy preparation
If the molecular signature indicates a positive result, preparation for neoadjuvant chemotherapy begins. This phase may include the use of bevacizumab, a medication administered through intravenous infusion.
Step 4
Chemotherapy phase
Undergo chemotherapy treatment, which may or may not include bevacizumab, depending on the pre-treatment assessment. Bevacizumab is provided as Avastin 25 mg/ml concentrate for solution for infusion.
Step 5
Treatment efficacy evaluation
The primary endpoint of the chemotherapy part of the study is evaluated after the completion of chemotherapy treatment. This assessment focuses on the overall effectiveness of the treatment regimen.

Who can join the trial?

15 criteria

Must be able to give signed informed consent, agreeing to follow the study's requirements and restrictions.
Women or men aged 18 to 80 years with a type of breast cancer that is **hormone receptor positive** and **HER2 negative**. This means the cancer grows in response to hormones but does not have a protein called HER2.
The cancer must be confirmed by a test called **histology** or **cytology**, and it should be measurable on an ultrasound, meaning it is larger than 20 mm.
Should be eligible for a type of treatment called **neoadjuvant chemotherapy**, which is given before surgery. This is determined by the doctor using specific tests that show a risk of the cancer coming back or by a test called **Ki67** that measures how fast cancer cells are growing.
Must have a **WHO performance status** of 0 or 1, which means the patient is fully active or has some symptoms but can still do light work.
Must have good blood health, with enough **neutrophils** (a type of white blood cell), **platelets** (cells that help blood clot), and **hemoglobin** (a protein in red blood cells).
Male patients should use condoms during the study and for 16 weeks after stopping the study drug. This is because the drug might affect sperm health.
Must have good liver health, with normal levels of **bilirubin** (a substance made by the liver) and liver enzymes called **ALT** and **AST**.
Must have good kidney health, with normal levels of **creatinine** (a waste product filtered by the kidneys) and a good **creatinine clearance** rate, which measures how well the kidneys are working.
Must have low levels of **protein** in the urine. If high levels are found, further testing is needed to ensure it is not too high.
Women who can have children must use two reliable forms of birth control during the study and for four weeks after stopping the study drug, or they must show they cannot have children due to menopause or surgery.
For certain treatments, the cancer must have an **ER positive score** in at least 50% of the tumor cells. This means the cancer cells have a lot of hormone receptors.
Must have normal blood clotting ability, shown by tests called **INR** and **APTT**.
Pregnant or breastfeeding women cannot participate in the study.
Must provide a signed and dated written consent form before any study-specific procedures or tests are done.

Who cannot join the trial?

4 criteria

Patients who do not have **hormone receptor positive HER2 negative breast cancer**. This means the cancer cells do not have certain proteins that are targeted by the study treatment.
Patients who are not within the specified age range for the study. The study may have specific age requirements.
Patients who are not female or male, as the study includes both genders.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Helse Stavanger HF
Stavanger, Norway
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Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

Capivasertib
is a medication being studied for its potential to enhance the effects of hormone therapy in patients with hormone receptor-positive, HER2-negative breast cancer. It is used in combination with other treatments to see if it can improve outcomes before surgery.
Letrozole
is a type of hormone therapy used to treat breast cancer. It works by lowering estrogen levels in the body, which can help slow or stop the growth of certain types of breast cancer cells that need estrogen to grow.
Bevacizumab
is a medication that may be used in combination with chemotherapy for certain patients. It works by blocking the growth of new blood vessels that tumors need to grow, potentially helping to shrink the tumor before surgery.

What is already known about the treatment

Capivasertib
Capivasertib is administered orally and is currently being studied in clinical trials for its potential use in treating hormone receptor-positive, HER2-negative breast cancer. It is not yet widely approved for general medical use but shows promise in ongoing research. The main therapeutic indication is for breast cancer patients who fit the specific hormone receptor profile. Capivasertib works by inhibiting certain enzymes involved in cancer cell growth, specifically targeting the AKT pathway, which is crucial for cell survival and proliferation. It is classified as a targeted cancer therapy.
Letrozole
Letrozole is taken orally and is an established medication used in the treatment of hormone receptor-positive breast cancer, particularly in postmenopausal women. It is widely recognized and utilized in medical practice. The primary therapeutic indication is to reduce estrogen levels, thereby slowing the growth of certain types of breast tumors that require estrogen to grow. Letrozole functions by inhibiting the aromatase enzyme, which is responsible for converting androgens into estrogens. It is classified as an aromatase inhibitor.
Bevacizumab
Bevacizumab is administered via intravenous infusion and is used in various cancer treatments, including breast cancer, although its use in breast cancer is more selective and based on specific clinical criteria. It is an approved medication in many countries for certain cancer types. The main therapeutic indication is to inhibit the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. Bevacizumab works by blocking vascular endothelial growth factor (VEGF), a protein that stimulates blood vessel formation. It is classified as an angiogenesis inhibitor.

Investigated diseases

Hormone Receptor Positive HER2 Negative Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors, meaning the cancer cells grow in response to hormones like estrogen or progesterone. It is HER2 negative, indicating that the cancer cells do not have an excess of the HER2 protein on their surfaces. This type of breast cancer tends to grow more slowly than other types and may respond well to hormone therapy. The progression of the disease can vary, but it often involves the growth of tumors in the breast tissue, which may spread to nearby lymph nodes. Over time, if not managed, it can potentially spread to other parts of the body. The focus of treatment often involves targeting the hormone receptors to slow or stop the growth of the cancer cells.