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Study of Fluoroestradiol F-18 and Biomarkers for Women with ER-Positive HER2-Negative Metastatic Breast Cancer After CDK4/6 Inhibitor Therapy

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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 a type of breast cancer known as ER-positive HER2-negative metastatic breast cancer. This form of cancer is characterized by the presence of estrogen receptors (ER-positive) and the absence of human epidermal growth factor receptor 2 (HER2-negative). The trial is designed for women whose cancer has progressed after initial treatment with a combination of drugs called CDK4/6 inhibitors and aromatase inhibitors.

The study will explore the effectiveness of two different types of treatments as a second line of therapy. One group of participants will receive chemotherapy, while another group will receive endocrine therapy. The trial will use a special imaging technique called 18F-FES PET/CT to help determine the best treatment option. This imaging method involves a substance called fluoroestradiol F-18, which is injected into the body to help visualize certain features of the cancer. The purpose of the study is to assess which treatment is more effective for patients with specific cancer characteristics.

Participants in the trial will be monitored over time to evaluate their response to the treatment. The study will look at how long patients live without their cancer getting worse, known as progression-free survival, and other outcomes like overall survival and response rates. The trial will also record any side effects experienced by participants. The study aims to provide valuable information that could help improve treatment options for women with this type of breast cancer.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria, including age, health status, and previous treatment history.
Informed consent is required, ensuring understanding of the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment is conducted, which includes a review of medical history and current health status.
Imaging tests, such as 18F-FDG PET/CT, are performed to evaluate the disease.
Step 3
Randomization
Participants are randomly assigned to one of two treatment groups: chemotherapy (Arm B) or endocrine therapy (Arm C).
The assignment is based on specific health markers and imaging results.
Step 4
Treatment administration
For those in the chemotherapy group, treatment involves the administration of chemotherapy drugs as determined by the study protocol.
Participants in the endocrine therapy group receive hormone therapy, which may include medications that block or lower estrogen levels.
Step 5
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor health status and treatment effects.
Progression-free survival (PFS) is assessed, which measures the time until the disease progresses or the participant passes away.
Step 6
Evaluation of outcomes
Secondary outcomes, such as overall survival (OS) and objective response rate (ORR), are evaluated.
Quality of life is assessed using the QLQ-C30 questionnaire at baseline and after two months of treatment.
Step 7
Completion of study
The study is estimated to conclude by June 16, 2028.
Final assessments are conducted to evaluate the long-term effects and outcomes of the treatments.

Who can join the trial?

12 criteria

Must have a type of breast cancer called metastatic invasive breast carcinoma.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
Must sign a document called informed consent, which shows understanding and agreement to participate.
Must be part of a social security system.
Must be a female aged 18 years or older.
Must have a life expectancy of more than 3 months.
Must have an ECOG performance status of 0 to 2, which is a scale that measures how well a person can perform daily activities.
Must have breast cancer that is Estrogen Receptor (ER)-positive and HER2-negative, based on the most recent tissue sample.
Must have a sample of the tumor available for testing.
Must have experienced disease progression after more than 6 months on first line therapy with an aromatase inhibitor and CDK4/6 inhibitor, and be eligible for second line therapy.
Must have available imaging from a test called 18F-FDG PET/CT.
Must have disease that can be evaluated and measured using specific criteria called RECIST and PERCIST.

Who cannot join the trial?

7 criteria

Patients who have not been diagnosed with ER+ HER2- metastatic breast cancer. This is a type of breast cancer that has specific characteristics and has spread to other parts of the body.
Patients who have not previously been treated with a CDK4/6 inhibitor and an aromatase inhibitor. These are specific types of medications used in the treatment of breast cancer.
Patients who do not show unfavorable 18F-FES PET/CT features. This refers to specific results from a type of imaging test that helps to see how the cancer is behaving.
Patients who do not have high circulating markers. These are substances in the blood that can indicate the presence or progression of cancer.
Patients who are not women, as the study is only for female participants.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population that is not selected for this study.

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Verified sites

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

Verified
Centr Georges Francois Leclerc
Dijon, France
Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Chemotherapy
is a type of cancer treatment that uses drugs to destroy cancer cells. In this clinical trial, chemotherapy is being tested as a second line of treatment for patients with ER-positive, HER2-negative metastatic breast cancer. The goal is to see how effective chemotherapy is in treating patients who have already been treated with CDK4/6 inhibitors and have certain unfavorable features or high levels of specific markers in their blood.
Endocrine Therapy
is a treatment that blocks or lowers the amount of hormones in the body to slow down or stop the growth of cancer. This therapy is being evaluated in the trial as an alternative second line treatment for the same group of breast cancer patients. The study aims to determine if endocrine therapy is more effective than chemotherapy for these patients after they have received CDK4/6 inhibitors.

Fluoroestradiol F-18

What is already known about the treatment

EstroTEP – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating women with ER-positive, HER2-negative metastatic breast cancer who have not responded to first-line therapy with a CDK4/6 inhibitor and an aromatase inhibitor. It is being evaluated as a potential second-line therapy option. EstroTEP works by targeting estrogen receptors, which are involved in the growth of certain types of breast cancer cells. It is classified as an endocrine therapy, which is a type of treatment that blocks or lowers the amount of hormones in the body to slow down or stop the growth of cancer.

Investigated diseases

Metastatic Breast Cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It is characterized by the presence of cancer cells in distant organs, which can lead to various symptoms depending on the organs affected. In the context of ER+ HER2- metastatic breast cancer, the cancer cells grow in response to estrogen but do not have an excess of the HER2 protein. The disease often progresses after initial treatments, such as CDK4/6 inhibitors and aromatase inhibitors, which aim to slow down or stop the growth of cancer cells. As the disease advances, patients may experience increased symptoms and require additional therapies to manage the progression.