Study on Early Breast Cancer Treatment with Palbociclib, Tamoxifen, and Exemestane for Patients with Estrogen Receptor Positive Tumors

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What is this study about?

This clinical trial is focused on studying treatments for early breast cancer, specifically targeting tumors that are estrogen receptor positive with either high or slow growth rates and may have spread to nearby lymph nodes. The study aims to evaluate the effects of a new treatment approach using the medication palbociclib, known by its brand name IBRANCE, compared to standard chemotherapy. Palbociclib is a type of medication that helps to slow down the growth of cancer cells. The trial will also involve other medications such as tamoxifen, exemestane, letrozole, anastrozole, and paclitaxel, which are commonly used in treating breast cancer.

The purpose of the study is to determine how effective palbociclib is when used before surgery, known as neoadjuvant treatment, in improving the response of the cancer to treatment and the long-term outcomes for patients. Participants in the study will receive either palbociclib or standard chemotherapy, and their response to the treatment will be monitored over a period of time. The study will also look at the safety of the treatments and how they affect the quality of life of the participants.

Throughout the study, participants will undergo regular assessments to monitor the size and characteristics of their tumors, as well as their overall health. The study will help to understand the best treatment options for patients with this type of breast cancer and may lead to improved treatment strategies in the future. The trial is part of a larger research effort to tailor cancer treatments based on the specific characteristics of the tumor, which is known as a translational phase II trial based on molecular subtypes.

1 joining the trial

Upon joining the trial, you will provide written informed consent, confirming your understanding and agreement to participate.

You will undergo initial assessments to confirm eligibility, including a review of your medical history and current health status.

2 initial treatment phase

The trial begins with a 12-week period of primary medical treatment. During this time, you may receive either palbociclib or standard chemotherapy, depending on your specific treatment plan.

Palbociclib is administered orally in the form of 125 mg film-coated tablets. The dosage and frequency will be determined by your healthcare provider.

3 monitoring and assessments

Throughout the trial, regular monitoring and assessments will be conducted to evaluate your response to the treatment.

These assessments may include clinical evaluations, imaging tests, and laboratory tests to measure the impact of the treatment on your condition.

4 adjustment of treatment

Based on the results of the initial treatment phase, your treatment plan may be adjusted. This could involve a change in medication or dosage.

The goal is to optimize your response to the treatment and improve long-term outcomes.

5 ongoing treatment and follow-up

You will continue to receive treatment as per the adjusted plan, with ongoing monitoring to track your progress.

Regular follow-up appointments will be scheduled to ensure your safety and to address any concerns or side effects you may experience.

6 completion of trial

At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment on your condition.

You will receive information about the results of the trial and any further steps or recommendations for your care.

Who Can Join the Study?

Provide written informed consent, which means you agree to participate after being informed about the study.
Be a female or male patient with breast cancer confirmed by a test called histology, which examines tissue under a microscope.
Have tumor and blood samples available. The cancer type should be luminal, confirmed by a test called immunohistochemistry, with ER (estrogen receptor) being 10% or higher, and not HER2 3+ or amplified.
Be aged 35 years or older. Elderly patients should be in a condition suitable for the planned therapy.
Have primary breast cancer that is larger than 20 mm in diameter and/or have confirmed regional lymph node metastases, which means the cancer has spread to nearby lymph nodes.
Have adequate bone marrow, renal (kidney), hepatic (liver), and cardiac (heart) functions, and no other uncontrolled medical or psychiatric disorders.
Have an ECOG performance status of 0-1, which is a scale used to assess how the disease affects daily living abilities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Have primary breast cancer as defined above, plus at most 2 well-defined distant metastases (cancer spread to other parts of the body) that can be treated with stereotactic radiotherapy, provided this treatment is available.

Who Cannot Join the Study?

Patients who have a different type of cancer other than early breast cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to give informed consent or understand the study requirements.
Patients who are pregnant or breastfeeding.
Patients who have a serious medical condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who have an allergy or sensitivity to the study medication.
Patients who have a history of non-compliance with medical treatments.
Patients who have a mental health condition that might interfere with their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Karolinska University Hospital	Solna	Sweden
Sankt Gorans Sjukhus	Stockholm	Sweden
Soedersjukhuset AB	Stockholm	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	18.03.2016

Trial locations

Investigated drugs:

Palbociclib is a medication used in this clinical trial to treat certain types of breast cancer. It works by blocking specific proteins in cancer cells, which helps to stop the cells from growing and dividing. This medication is often used in combination with other treatments to improve its effectiveness. In this trial, it is being compared to standard chemotherapy to see how well it works in treating tumors that are sensitive to hormones.

Investigated diseases:

Early breast cancer – Early breast cancer refers to cancer that is confined to the breast or has only spread to nearby lymph nodes. It typically begins as a small tumor or abnormal cells within the breast tissue. As the disease progresses, it may spread to the lymph nodes under the arm or near the collarbone. The growth of cancer cells can lead to changes in the size or shape of the breast, and sometimes cause skin dimpling or nipple discharge. Early detection is crucial as it is more likely to be treated successfully before it spreads further. The progression of early breast cancer can vary, with some cases remaining localized for a long time, while others may advance more rapidly.

Trial ID:

2024-519019-32-00

Protocol code:

PREDIX LumB

NCT ID:

NCT02603679

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Early Breast Cancer Treatment with Palbociclib, Tamoxifen, and Exemestane for Patients with Estrogen Receptor Positive Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?