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Study of personalized treatment using drug combination therapy for young women with early stage hormone receptor-positive breast cancer based on gene expression testing

Verified siteRegistered drugNo placebo

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Verified & featuredResponsive
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
Not recruiting

What is this trial about?

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

This clinical trial focuses on treating early breast cancer in premenopausal women whose cancer is hormone receptor-positive and HER2-negative. The study aims to evaluate whether using a gene expression test called Prosigna can help determine which patients need chemotherapy and which can safely avoid it while receiving hormone therapy. The trial specifically targets high-risk cases determined by tumor size and the presence of cancer in lymph nodes.

The study will use several medications including paclitaxel, docetaxel, epirubicin, doxorubicin, and cyclophosphamide as chemotherapy options. For hormone therapy, the treatments include tamoxifen, anastrozole, letrozole, exemestane, and hormone-suppressing medications like goserelin, triptorelin, and leuprorelin.

The treatment approach will be personalized based on the results of the gene expression test. Patients will receive either standard chemotherapy followed by hormone therapy, or hormone therapy alone, depending on their test results. The study will monitor patients for many years to compare the effectiveness of these treatment approaches in preventing cancer recurrence and ensuring long-term survival.

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 assessment and randomization
After breast and axillary surgery (within 12 weeks), your tissue sample will be analyzed using the Prosigna® test to guide treatment decisions
You will be assigned to one of two treatment groups based on random selection
Step 2
Treatment pathway determination
Based on your group assignment and test results, your treatment path will be determined
The treatment may include chemotherapy or hormone therapy alone, depending on your specific case
Step 3
Chemotherapy (if prescribed)
Medications may include: paclitaxel, cyclophosphamide, epirubicin, docetaxel, or doxorubicin
These medications are given through an intravenous (IV) line
Step 4
Hormone therapy
You will receive hormone therapy medications which may include: anastrozole, tamoxifen, letrozole, or exemestane taken by mouth
Additional hormone medications may be given by injection under the skin (subcutaneous): triptorelin, leuprorelin, or goserelin
Step 5
Follow-up period
Regular health assessments will monitor your progress
You will complete questionnaires about your quality of life and symptoms
Physical activity levels, body mass index, and other health measures will be tracked
The study continues until 2038

Who can join the trial?

11 criteria

You must be female and 35 years or older
You must be premenopausal (still having menstrual periods)
You must have signed a written informed consent before any study procedures
You must have been diagnosed with breast cancer that is: - Hormone receptor-positive (responds to hormones) - HER2-negative (does not have high levels of HER2 protein) - Has either: - 1-3 affected lymph nodes with any tumor size, or - No affected lymph nodes but tumor size of at least 50mm
Your breast and lymph node surgery must have been completed within the last 12 weeks
You must be physically fit enough to receive chemotherapy, as determined by your doctor
A tissue sample from your surgery must be available for testing
You must agree to use effective birth control during treatment and for the time specified in the medication guide, unless your doctor approves attempting pregnancy after at least 18 months of hormone therapy
You must be covered by a health insurance or social security system
If you had hormone therapy before surgery, it must not have exceeded 8 weeks
If you have cancer in both breasts, the second breast tumor must not require chemotherapy on its own and must not be hormone receptor-negative or HER2-positive

Who cannot join the trial?

13 criteria

Age below 18 or above 55 years
Male patients (study is for females only)
Post-menopausal women (only pre-menopausal women can participate)
Breast cancer that is HER2-positive (showing high levels of a protein that promotes cancer growth)
Breast cancer that is hormone receptor negative (not responding to hormonal therapy)
Tumor smaller than 50mm if lymph nodes are not affected
More than 3 affected lymph nodes (structures that are part of the immune system)
Previous chemotherapy treatment for breast cancer
Metastatic disease (cancer that has spread to other parts of the body)
Pregnancy or breastfeeding
Participation in other clinical trials
History of other cancers in the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
Serious heart, liver, or kidney disease that could interfere with treatment

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Verified sites

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

Verified & featuredResponsive
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
Not recruiting
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy

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Investigated drugs

Based on the provided trial data about early breast cancer treatment, the medications/therapies involved are: Chemotherapy is a treatment that uses strong drugs to kill cancer cells or stop them from growing. It is used as an adjuvant therapy, which means it's given after the main treatment to lower the risk of cancer returning. Endocrine therapy is a treatment for hormone receptor-positive breast cancer that works by blocking or lowering the levels of hormones that can stimulate cancer growth. It's used as a long-term treatment to reduce the risk of cancer recurrence. The trial also uses Prosigna, which is not a medication but a diagnostic test that analyzes gene expression patterns in breast cancer tissue to help determine the risk of cancer recurrence and guide treatment decisions.

What is already known about the treatment

Based on the provided clinical trial data, I'll describe the relevant medications mentioned: Prosigna - A diagnostic gene expression test used to analyze breast cancer tumors in premenopausal women with HR-positive/HER2-negative breast cancer. This molecular diagnostic tool is administered by analyzing tumor tissue samples to measure the expression of specific genes, helping to determine the most appropriate treatment approach. The test aids in making decisions about whether adjuvant chemotherapy is necessary alongside endocrine therapy, functioning by examining multiple genetic markers associated with cancer progression risk. Prosigna belongs to the class of genomic assays used in personalized cancer treatment planning. Note: While the trial mentions chemotherapy (CT) and endocrine therapy (ET), specific medication names are not provided in the source data, so I cannot create detailed descriptions for those treatments.

Investigated diseases

Breast Cancer (HR-positive/HER2-negative) - A type of breast cancer characterized by the presence of hormone receptors (HR) and absence of HER2 protein on cancer cells. This cancer begins in the breast tissue and is stimulated to grow by hormones like estrogen and progesterone. The disease can develop in the milk ducts, milk-producing glands, or other breast tissue. It may spread to nearby lymph nodes and can vary in size from small tumors to larger masses. The condition typically develops gradually and can affect one or both breasts.