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Study on Extended Endocrine Therapy for High-Risk Breast Cancer Patients Using Tamoxifen, Exemestane, Anastrozole, and Letrozole

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 focuses on patients with breast cancer, specifically those who have a type known as high-risk luminal breast cancer. The study aims to explore the effectiveness of different extended treatments after the initial therapy. For women who were premenopausal at the time of diagnosis and have become postmenopausal after five years of treatment with tamoxifen, the study will compare the continued use of tamoxifen for another five years with a switch to five years of aromatase inhibitors (AI), which are medications that help reduce estrogen levels in the body.

For postmenopausal women who have already completed five years of AI treatment, the study will investigate whether switching to five years of tamoxifen is more beneficial than continuing with AI for two more years. The medications being studied include exemestane, anastrozole, letrozole, and tamoxifen. These medications are taken orally in the form of tablets. The purpose of the study is to determine which treatment strategy is more effective in improving overall survival and other health outcomes for patients.

Participants in the study will be randomly assigned to different treatment groups and will receive either the study medication or a placebo. The study will last for a period of up to 120 months, during which participants will be monitored for various health outcomes, including survival rates, disease progression, and quality of life. The trial will help to optimize treatment strategies for breast cancer patients, potentially leading to better long-term outcomes.

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, eligibility is confirmed based on specific criteria. For premenopausal women at diagnosis who have become postmenopausal, the criteria include having luminal breast cancer, being treated with tamoxifen for at least 80% of a 5-year period, and showing no signs of metastasis after treatment. For postmenopausal women at diagnosis, the criteria include having luminal breast cancer, being treated with aromatase inhibitors (AI) for at least 80% of a 5-year period, and showing no signs of metastasis after treatment.
Step 2
Treatment allocation
Participants are randomly assigned to different treatment groups. For women who were premenopausal at diagnosis and have become postmenopausal, the study investigates if switching to 5 years of aromatase inhibitors (AI) is more effective than continuing with tamoxifen for 5 years. For postmenopausal women at diagnosis, the study examines whether switching to 5 years of tamoxifen is more effective than continuing with AI for 2 years.
Step 3
Medication administration
Participants take the assigned medication orally. The medications involved in the study include exemestane, anastrozole, tamoxifen, and letrozole. The specific medication, dosage, and duration depend on the group to which the participant is assigned.
Step 4
Monitoring and follow-up
Participants are monitored for overall survival, invasive disease-free survival, distant disease-free survival, and breast cancer-specific survival. Other factors such as toxicity, quality of life, adherence to medication, healthcare resource utilization, sick leave, and early retirement are also assessed.
Step 5
Completion of the study
The study is estimated to end by December 31, 2036. Participants will continue to be monitored and assessed until the study's completion.

Who can join the trial?

12 criteria

Participants must be women.
Participants must have been diagnosed with **breast cancer**.
Participants must have **luminal breast cancer**, which means the cancer is **estrogen-receptor positive** (10% or more) and **HER2-negative**.
For Cohort 1: Participants were **premenopausal** or **perimenopausal** at the time of diagnosis and have become **postmenopausal** after treatment.
For Cohort 1: Participants must have been treated with **tamoxifen** for at least 80% of a 5-year period, with a 6-month flexibility around treatment completion.
For Cohort 1: Participants must show no clinical signs of **metastasis** (cancer spread) after 5 years of tamoxifen treatment.
For Cohort 1: Participants must have had **cN+ breast cancer** at diagnosis, indicating the need for extended treatment.
For Cohort 1: Participants must be **postmenopausal** at the start of the study, as defined by specific guidelines.
For Cohort 2: Participants were **postmenopausal** at the time of diagnosis.
For Cohort 2: Participants must have been treated with **aromatase inhibitors (AI)** for at least 80% of a 5-year period, with a 6-month flexibility around treatment completion.
For Cohort 2: Participants must show no clinical signs of **metastasis** after 5 years of AI treatment.
For Cohort 2: Participants must have had **cN+ breast cancer** at diagnosis, indicating the need for extended treatment.

Who cannot join the trial?

5 criteria

Patients who are not women cannot participate.
Patients who are not postmenopausal cannot participate.
Patients who have not been diagnosed with **breast cancer** cannot participate.
Patients who have not completed an initial 5-year treatment with **tamoxifen** or **aromatase inhibitors (AI)** cannot participate. **Tamoxifen** and **aromatase inhibitors** are types of medication used to treat breast cancer.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection, like children or people with certain disabilities.

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Verified sites

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

Verified
Karolinska University Hospital
Solna, Sweden
Verified
Lund University Hospital
Lund, Sweden
Verified
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Gothenburg, Sweden

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Investigated drugs

Tamoxifen
is a medication used in the treatment of breast cancer. It works by blocking estrogen receptors on breast cancer cells, which can slow or stop the growth of tumors that need estrogen to grow. In this trial, tamoxifen is used as an extended adjuvant therapy for women who have completed an initial 5-year course of treatment. The study aims to determine if continuing tamoxifen for an additional 5 years is beneficial for patients.
Aromatase Inhibitors (AI)
are a class of drugs used in the treatment of breast cancer in postmenopausal women. They work by reducing the amount of estrogen produced in the body, which can help slow the growth of estrogen-dependent breast cancer cells. In this trial, aromatase inhibitors are used as part of a switching strategy for extended adjuvant therapy. The study investigates whether switching to aromatase inhibitors for 5 years after an initial 5-year treatment with tamoxifen is more effective for certain patients.

What is already known about the treatment

Tamoxifen
Tamoxifen is administered orally in tablet form and is widely used in the treatment of breast cancer. It is a well-established medication in medical literature, primarily used as an adjuvant therapy for hormone receptor-positive breast cancer. Tamoxifen works by blocking estrogen receptors on breast cancer cells, preventing estrogen from binding and stimulating cancer growth. It is classified as a selective estrogen receptor modulator (SERM).
Aromatase Inhibitors (AI)
Aromatase inhibitors are taken orally and are commonly used in the treatment of breast cancer, particularly in postmenopausal women. These medications are well-documented in medical literature and are used to reduce the risk of cancer recurrence. Aromatase inhibitors work by blocking the enzyme aromatase, which is responsible for converting androgens into estrogen, thereby lowering estrogen levels in the body. They are classified as hormone therapy agents.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. It is often categorized by hormone receptor status, such as estrogen receptor-positive or negative, which influences its behavior and response to treatment. Breast cancer can affect both men and women, though it is much more common in women. Early detection through screening can significantly impact the course of the disease.