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Study on the Effects of Chemotherapy and Endocrine Therapy in Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer Using Tamoxifen and Anastrozole

Verified siteRegistered drugNo placebo

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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 the effects of chemotherapy in patients with a specific type of breast cancer known as hormone receptor-positive and HER2-negative breast cancer. This type of breast cancer is characterized by the presence of 1 to 3 positive lymph nodes and a Recurrence Score (RS) of 25 or less, which is determined by a test called Oncotype DX. The purpose of the study is to understand whether adding chemotherapy to standard hormone therapy improves the chances of staying cancer-free for these patients.

The study involves several medications that are commonly used in chemotherapy. These include Fluorouracil, Cyclophosphamide, Docetaxel, Epirubicin, Doxorubicin, and Paclitaxel, which are given as injections or infusions. Additionally, Tamoxifen and Anastrozole are used as oral tablets. These medications work in different ways to stop the growth of cancer cells. Some patients will receive these chemotherapy drugs, while others will receive a placebo, to compare the outcomes.

Participants in the study will be randomly assigned to receive either the standard hormone therapy alone or in combination with chemotherapy. The study will monitor the participants over time to see how well they do in terms of disease-free survival, which means living without the cancer coming back. The trial will help determine if the benefit of chemotherapy depends on the Recurrence Score and will aim to find the best way to decide who should receive chemotherapy. The study is expected to continue until 2031.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial registration
Upon joining the study, registration is required. This involves confirming a diagnosis of breast cancer with specific characteristics: 1-3 positive lymph nodes, hormone receptor-positive, and HER2-negative status.
A test called Oncotype DX® is used to determine a recurrence score (RS). This score must be 25 or less to proceed.
Step 2
Surgery and recovery
Surgery is performed to remove the breast cancer. This may involve breast-conserving surgery with planned radiation or a total mastectomy.
Recovery from surgery is monitored, and registration for the next step must occur within 84 days post-surgery.
Step 3
Randomization
Patients are randomly assigned to one of two groups: one receiving standard endocrine therapy alone, and the other receiving both endocrine therapy and chemotherapy.
This step ensures that the treatment assignment is unbiased and based on chance.
Step 4
Endocrine therapy
Endocrine therapy involves taking medications that block hormones that can promote cancer growth. This may include tamoxifen (20 mg tablets taken orally) or anastrozole (1 mg film-coated tablets taken orally).
The duration and specific choice of medication depend on individual treatment plans.
Step 5
Chemotherapy (if applicable)
For those assigned to receive chemotherapy, several medications may be administered intravenously. These include fluorouracil, cyclophosphamide, docetaxel, epirubicin hydrochloride, doxorubicin hydrochloride, and paclitaxel.
The specific regimen, dosage, and frequency are determined by the healthcare provider based on the treatment protocol.
Step 6
Follow-up and monitoring
Regular follow-up appointments are scheduled to monitor health status and any side effects from the treatment.
The primary focus is on disease-free survival, overall survival, and monitoring for any recurrence of cancer.

Who can join the trial?

15 criteria

Patients must have a confirmed diagnosis of breast cancer with 1-3 positive lymph nodes. The cancer must be **hormone receptor-positive**, meaning it grows in response to hormones like estrogen or progesterone, and **HER2-negative**, meaning it does not have high levels of a protein called HER2.
Patients must not need long-term treatment with **systemic steroids** (medications that reduce inflammation) or other drugs that suppress the immune system. Inhaled steroids are allowed.
Patients must not have taken certain hormone-related medications, like **aromatase inhibitors** or **selective estrogen receptor modulators** (e.g., tamoxifen or raloxifene), in the last 5 years.
Patients must not be pregnant or breastfeeding, as the treatment could harm a baby or nursing infant.
Patients must not have had any other cancer, except for certain types of skin cancer or cervical cancer, unless they have been cancer-free for 5 years.
Patients must be informed about the study and sign a consent form agreeing to participate.
Patients must have a **Recurrence Score (RS)** of 25 or less, determined by a test called Oncotype DX®. This score helps predict the chance of cancer returning.
Patients must register for the study within 84 days after their main surgery and must not have started chemotherapy or hormone therapy for their breast cancer before joining the study.
Patients can have multiple areas of cancer in one or both breasts, but must have had a procedure to check the lymph nodes in the armpit area.
Patients must have had either breast-conserving surgery with planned radiation or a total mastectomy. The surgery must have removed all cancerous tissue.
Patients must be willing to provide tissue samples for testing if the Oncotype DX® test has not been done yet.
Patients must be female and at least 18 years old. The test used in the study has not been validated for men with breast cancer.
Patients must have a complete medical history and physical exam within 28 days before joining the study.
Patients must be in good enough health to receive certain types of chemotherapy, specifically those based on **taxane** or **anthracycline** drugs.
Patients must not have started any chemotherapy or hormone therapy for their breast cancer before joining the study.

Who cannot join the trial?

6 criteria

Patients who have more than 3 positive lymph nodes cannot participate. Lymph nodes are small glands that are part of the immune system.
Patients with a **Recurrence Score (RS)** greater than 25 are excluded. The RS is a number that helps predict the chance of cancer returning.
Patients who do not have **Hormone Receptor-Positive** breast cancer are excluded. This means the cancer cells do not have receptors for hormones like estrogen or progesterone.
Patients with **HER2-Positive** breast cancer cannot participate. HER2 is a protein that can promote the growth of cancer cells.
Only female patients are eligible, so male patients are excluded.
Patients who are considered part of a vulnerable population, which means they might need special protection or care, are excluded.

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Verified sites

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

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Cork University Hospital
Cork, Ireland
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St Vincent's University Hospital
Dublin, Ireland
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University Hospital Limerick
Limerick, Ireland

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Investigated drugs

Endocrine Therapy
is a treatment used to block or lower the amount of hormones in the body to slow down or stop the growth of hormone-sensitive tumors. In this trial, it is used for patients with hormone receptor-positive breast cancer to help prevent the cancer from returning.
Chemotherapy
is a type of cancer treatment that uses drugs to destroy cancer cells. It works by stopping or slowing the growth of cancer cells, which grow and divide quickly. In this trial, chemotherapy is being tested to see if it provides additional benefits to patients with certain types of breast cancer when used alongside endocrine therapy.

What is already known about the treatment

Endocrine Therapy
This medication is administered orally or through injection, depending on the specific drug used within the therapy. It is currently well-established in medical practice and literature, particularly for treating hormone receptor-positive breast cancer. The main therapeutic indication is for patients with hormone receptor-positive, HER2-negative breast cancer, especially those with 1-3 positive lymph nodes and a recurrence score of 25 or less. At the molecular level, endocrine therapy works by blocking or lowering the amount of hormones in the body to slow or stop the growth of cancer cells that rely on these hormones. It is classified pharmacologically as a hormone therapy.
Chemotherapy
This treatment is typically administered intravenously, although some forms can be taken orally. It is a standard and widely recognized treatment in oncology, used for various types of cancer, including breast cancer. The primary therapeutic indication in this context is for patients with hormone receptor-positive, HER2-negative breast cancer with a recurrence score of 25 or less, to determine if chemotherapy provides additional benefits. Chemotherapy works by targeting and killing rapidly dividing cancer cells, interfering with their growth and division at the molecular level. It is classified as an antineoplastic or cytotoxic agent.

Investigated diseases

Breast Cancer, Hormone Receptor-Positive, HER2-Negative – 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 surface. The disease can progress by spreading to nearby lymph nodes, and in this study, it specifically involves patients with 1-3 positive lymph nodes. The recurrence score (RS) is used to assess the likelihood of cancer returning, with a score of 25 or less indicating a lower risk of recurrence. The progression of the disease can involve local, regional, or distant recurrence, and the study aims to understand how chemotherapy affects disease-free survival in these patients.