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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Karolinska University Hospital	Solna	Sweden
Norrlands University Hospital	Umea	Sweden
Sankt Gorans Sjukhus	Stockholm	Sweden
Lund University Hospital	Lund	Sweden
Region Oerebro Laen	Orebro	Sweden
Eskilstuna Regional Hospital	Eskilstuna	Sweden
Vexlwekn Rypkvkii Hjpzxhgm	Vasteras	Sweden
Jbygmrzfg Rjztswhk Hqaluzrv	Jönköping	Sweden
Fadi Rgjcazsy Hvccislj	Falun	Sweden
Veeeu lcpiwfwe	Vaxjo	Sweden
Gtont Rjvczyem Hvlgitcm	Gavle	Sweden
Vhukg Lejgnxcj	Visby	Sweden
Lqunalzhyvdgn i Ktqpnz	Kalmar	Sweden
Uyvwedz Uzpdoubtlw Htoaixhs	Uppsala	Sweden
Saxfwcpguyh Umgllcsgpg Htxdcuxwedfflan Gryyceecyicknwzng	Gothenburg	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.01.2024

Trial locations

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.

Investigated diseases:

Breast cancer

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.

Trial ID:

2023-506135-14-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?