Recruiting

Study of Palbociclib and Fulvestrant for Women with Advanced Breast Cancer After Previous CDK4/6 Inhibitor and Hormonal Therapy

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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 treatment of women with a specific type of breast cancer known as hormone receptor-positive and HER2-negative breast cancer. This type of cancer can be locally advanced or metastatic, meaning it has spread to other parts of the body. The study involves women whose cancer has progressed after being treated with a combination of a CDK4/6 inhibitor and hormonal therapy. The treatment being tested in this trial is a combination of two medications: palbociclib and fulvestrant. Palbociclib is a type of medication known as a CDK4/6 inhibitor, which helps to slow down the growth of cancer cells. Fulvestrant is a hormonal therapy that works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells.

The purpose of this study is to evaluate how effective and safe the combination of palbociclib and fulvestrant is for women whose cancer has not responded to previous treatments. Participants in the study will receive either the combination of palbociclib and fulvestrant or a placebo. The study will monitor the participants over a period of time to see how their cancer responds to the treatment. This includes looking at how long the cancer stays under control and the overall survival of the participants. The study will also assess the safety and tolerability of the treatment, which means checking for any side effects that may occur.

Throughout the study, participants will undergo various tests and assessments to monitor their health and the progress of their cancer. These may include imaging tests like MRI or CT scans to measure the size of the cancer, as well as blood tests to check for any changes in the body. The study aims to provide valuable information about the potential benefits of using palbociclib and fulvestrant together for treating this type of breast cancer, especially after other treatments have not been successful.

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
Enrollment
Upon joining the study, the patient will provide written informed consent. This is a formal agreement to participate in the trial.
A liquid biopsy will be performed at the start of the study. This involves taking a blood sample to analyze cancer cells or DNA.
A tissue biopsy of the most accessible metastatic site is required at the start of the study, although it is not mandatory.
Step 2
Treatment initiation
The patient will begin treatment with palbociclib and fulvestrant.
Palbociclib is administered orally. The specific dosage and form (capsule or tablet) will be determined by the study protocol.
Fulvestrant is administered as an injection. The frequency and dosage will be specified by the study protocol.
Step 3
Treatment monitoring
The patient will undergo regular monitoring to assess the effectiveness and safety of the treatment.
This includes routine blood tests, imaging studies, and clinical evaluations to track the progression of the disease and any side effects.
Step 4
Disease progression assessment
If the disease progresses, another liquid biopsy will be performed to analyze changes in cancer cells or DNA.
A tissue biopsy of the most accessible metastatic site may be performed again, although it is not mandatory.
Step 5
End of treatment
The treatment will continue until the study's end date or until the patient experiences unacceptable side effects or disease progression that requires discontinuation of the study treatment.
The estimated end date for the trial is December 31, 2026.

Who can join the trial?

15 criteria

Must be an adult woman, 18 years or older, who is either pre-menopausal or post-menopausal.
Must have a type of breast cancer called **LABC** (locally advanced breast cancer) or **MBC** (metastatic breast cancer) that cannot be cured with surgery or radiation.
The cancer must have worsened after using a treatment called a **CDK4/6 inhibitor** combined with either an **aromatase inhibitor** or **tamoxifen**.
If the cancer returned after stopping the CDK4/6 inhibitor, it must have been at least 12 months since the last dose in the adjuvant setting (treatment given after the main treatment to prevent cancer from coming back).
If the cancer is metastatic, the patient must have had at least stable disease while on the first line of hormonal treatment with a CDK4/6 inhibitor plus an aromatase inhibitor or tamoxifen for at least 6 months.
Must agree to have a **liquid biopsy** (a blood test to look for cancer cells) at the start of the study and if the disease gets worse.
Must provide written consent to participate in the study.
Can have had up to one line of chemotherapy before starting the first line of hormonal treatment with a CDK4/6 inhibitor for metastatic disease.
Must have a confirmed diagnosis of **ER** (estrogen receptor) and/or **PgR** (progesterone receptor) positive breast cancer, and the cancer must be **HER2 negative**.
Premenopausal women must have had their ovaries removed, had ovarian radiation, or be on medication to stop ovarian function.
Must have evidence of cancer returning or getting worse after the last treatment before joining the study.
Can have received up to 28 days of **fulvestrant** (a type of hormone therapy) for advanced breast cancer before joining the study.
Must have at least one cancer lesion that can be measured accurately, or have specific types of bone lesions.
Must have adequate bone marrow, blood clotting, and organ function, as defined by specific medical tests.
Must have a life expectancy of more than 12 weeks.

Who cannot join the trial?

5 criteria

Patients who are not women. This study is only for women.
Patients who have not experienced disease progression after using a combination of a **CDK4/6 inhibitor** (a type of medication that helps control cancer cell growth) and hormonal therapy.
Patients who do not have **HR+** (hormone receptor-positive) and **HER2-** (human epidermal growth factor receptor 2-negative) breast cancer.
Patients who have not been treated with hormonal therapy in the past, such as **aromatase inhibitors** (medications that lower estrogen levels) or **tamoxifen** (a medication that blocks estrogen effects).
Patients who are not in the age range specified for the study.

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Verified sites

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

ASL Napoli 2 Nord - Ospedale Santa Maria delle Grazie
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Pozzuoli, Italy
Azienda Ospedaliera Papa Giovanni XXIII
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Bergamo, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
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Naples, Italy

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Investigated drugs

Palbociclib
is a medication used in this trial to help treat breast cancer. It works by blocking certain proteins in cancer cells, which can slow down or stop the growth of the cancer. This medication is often used in combination with other treatments to improve its effectiveness.
Fulvestrant
is another medication involved in the trial. It is used to treat hormone receptor-positive breast cancer. Fulvestrant works by blocking the effects of estrogen in the body, which can help slow or stop the growth of certain types of breast cancer cells.

Palbociclib

What is already known about the treatment

Palbociclib
This medication is administered orally in the form of capsules. It is currently used in the treatment of certain types of breast cancer, specifically in women with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. Palbociclib works by inhibiting proteins called CDK4 and CDK6, which are involved in cell division, thereby slowing down the growth of cancer cells. It is classified as a CDK4/6 inhibitor and is often used in combination with other hormonal therapies.
Fulvestrant
This medication is administered via intramuscular injection. It is used in the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women. Fulvestrant works by binding to estrogen receptors and degrading them, which reduces the growth of cancer cells that rely on estrogen. It is classified as an estrogen receptor antagonist and is often used when other hormonal therapies are no longer effective.

Investigated diseases

Hormone Receptor-Positive/HER2-Negative Locally Advanced Breast Cancer (LABC)
This type of breast cancer is characterized by the presence of hormone receptors and the absence of the HER2 protein. It is considered locally advanced when the cancer has spread beyond the breast to nearby tissues or lymph nodes but not to distant organs. The disease progresses as cancer cells continue to grow and invade surrounding tissues. Hormone receptor-positive cancers often rely on hormones like estrogen to grow, which can influence their progression. The absence of HER2 means that the cancer does not overexpress the HER2 protein, which can affect treatment options and disease behavior.
Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer (MBC)
This form of breast cancer is similar to LABC in terms of hormone receptor and HER2 status but is classified as metastatic when it has spread to distant parts of the body. The progression involves the spread of cancer cells through the bloodstream or lymphatic system to other organs. Hormone receptor-positive cancers may continue to grow in response to hormones, impacting their progression. The lack of HER2 overexpression means that the cancer does not have an excess of the HER2 protein, which can influence the disease's characteristics and progression.