Study of tamoxifen loading dose and Ki67 response in breast cancer patients before surgery (ENDO-67)

1 1 1 1

What is this study about?

This study focuses on patients with breast cancer that is hormone receptor-positive and HER2-negative. The research examines how the medication tamoxifen, which is used to treat breast cancer, works in patients before they undergo surgery. Tamoxifen is taken as a tablet by mouth and belongs to a group of medications called oncolytic agents that help fight cancer.

The main purpose of this research is to understand how quickly tamoxifen becomes effective in the body and how it affects certain markers in the tumor tissue. The study will investigate whether a shorter treatment period of three weeks can be as effective as the standard twelve-week treatment period. During the study, participants will receive tamoxifen tablets daily, with a maximum daily dose of 40 mg.

The research involves taking small samples of tumor tissue to measure a protein called Ki67, which helps determine how fast cancer cells are growing. The study will also measure levels of endoxifen (a substance that tamoxifen is converted into in the body) and monitor how the treatment affects hormone levels in the blood. Participants will be asked to complete questionnaires about their symptoms and overall well-being during the treatment period.

1 Initial treatment phase

You will begin taking tamoxifen medication orally for three weeks before your scheduled breast surgery

The medication will be administered according to a specific dosing schedule to achieve optimal blood levels

The standard dose is 20mg of tamoxifen taken by mouth daily

2 Tumor assessment – first stage

Multiple samples (biopsies) of your breast tumor will be taken to measure a protein called Ki67

The Ki67 measurement helps determine how your tumor is responding to the treatment

3 Blood tests – first stage

Blood samples will be collected to measure the levels of endoxifen (a substance that tamoxifen converts to in your body)

Hormone levels (estradiol and progesterone) in your blood will also be measured

4 Quality of life assessment

You will complete a questionnaire called FACT-ES about your experience with the treatment

5 Continued treatment phase

After surgery, you will continue taking tamoxifen for three months

The standard dose of 20mg daily will be maintained during this period

6 Final assessments

After three months, final blood tests will be performed to measure endoxifen levels

Hormone levels will be measured again

You will complete another FACT-ES questionnaire

Who Can Join the Study?

  • Patient must have newly diagnosed breast cancer that is:
    • At least 1.5 cm in size (T1c or larger)
    • Positive for estrogen receptors (ER+)
    • Negative for HER2 protein (HER2-)
    • Has a Ki-67 level of 10% or higher (Ki-67 is a protein that indicates how fast cancer cells are growing)
    • The tumor must still be in the breast (not yet surgically removed)
  • Must be 18 years or older
  • Must be planned to receive hormone therapy after surgery
  • Must have good overall health status (WHO performance status of 0-2, meaning able to carry out most daily activities)
  • The breast tumor must be suitable for taking multiple tissue samples
  • Must be suitable for treatment with tamoxifen (a type of hormone therapy medication)

Who Cannot Join the Study?

  • Patients with known metastatic disease (cancer that has spread to other parts of the body)
  • Previous chemotherapy or hormonal therapy within the last 6 months
  • Currently taking medications that interact with tamoxifen (including certain antidepressants)
  • History of blood clotting disorders or deep vein thrombosis
  • Severe liver disease or abnormal liver function
  • Pregnancy or breastfeeding
  • Known hypersensitivity to tamoxifen or its components
  • Participation in another clinical trial within the last 30 days
  • Psychiatric conditions that could interfere with study compliance
  • Uncontrolled medical conditions (such as diabetes or high blood pressure)
  • History of other malignancies within the past 5 years (except adequately treated non-melanoma skin cancer)
  • Unable to provide informed consent
  • Unable to follow study procedures or attend scheduled visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Efvqugy Ujjtdyoomsps Mkooihz Cciihpe Rmnmprntn (dxmtilv Mhy Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.11.2025

Trial locations

Investigated drugs:

Tamoxifen is a hormone therapy medication used in breast cancer treatment. It works by blocking the effects of estrogen in breast tissue. This medication helps prevent breast cancer cells from growing and dividing. It belongs to a class of drugs called selective estrogen receptor modulators (SERMs).

Endoxifen is an active metabolite that forms in the body after taking tamoxifen. It is considered one of the most important compounds that makes tamoxifen effective in treating breast cancer. The body creates endoxifen when it processes tamoxifen, and the levels of endoxifen in the body are important for the medication’s effectiveness.

Investigated diseases:

Breast cancer – A disease that occurs when cells in the breast tissue begin to grow abnormally and divide more rapidly than healthy cells. It typically starts in the cells of the lobules (milk-producing glands) or the ducts (passages that drain milk from the lobules to the nipple). As the cancer grows, cells can invade nearby healthy breast tissue and can travel through the lymphatic system or bloodstream to other areas of the body. The disease can develop in both women and men, though it’s much more common in women. Breast cancer may present as a painless lump, changes in breast size or shape, or changes in the skin over the breast.

Trial ID:
2025-521385-10-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study to test the safety and effectiveness of ONA-255 in patients with advanced cancer including breast cancer and gastric cancer

    Recruiting

    1 1
    Investigated diseases:
    Spain
  • A Study Comparing GDC-4198 Alone and with Giredestrant versus Abemaciclib with Giredestrant for Advanced Breast Cancer After Previous CDK4/6 Treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain