Study on Alisertib with Hormone Therapy for Patients with HR+, HER2- Recurrent or Metastatic Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as hormone receptor positive (HR+), HER2-negative breast cancer. This type of cancer can return or spread to other parts of the body, which is referred to as recurrent or metastatic breast cancer. The study is testing a new treatment approach that combines a medication called Alisertib with hormone therapy. Hormone therapy is a treatment that blocks or lowers the amount of hormones in the body to slow down or stop the growth of cancer.

The purpose of the study is to find the best dose of Alisertib when used with hormone therapy, ensuring it is both safe and effective for future use. The study will involve several medications, including Letrozole, Tamoxifen, Anastrozole, Exemestane, and Fulvestrant. These medications are commonly used in hormone therapy to treat breast cancer. Participants in the study will receive one of these medications along with Alisertib or a placebo. The study will last for a period of 28 days, during which the effects of the treatment will be closely monitored.

Throughout the study, participants will be observed for any side effects or changes in their condition. The study aims to gather information on how well the combination of Alisertib and hormone therapy works in controlling the cancer and improving the participants’ health. This information will help determine the potential of this treatment combination for future use in patients with HR+, HER2-negative breast cancer.

1 Enrollment and Initial Assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

A tumor tissue sample is required for biomarker assessment. If a new biopsy is not possible, an existing sample may be used.

2 Treatment Plan Discussion

The treatment plan is discussed, including the combination of alisertib with selected hormone therapies such as letrozole, tamoxifen, anastrozole, exemestane, or fulvestrant.

The choice of hormone therapy is based on previous treatments and current health status.

3 Medication Administration

Alisertib is taken orally in tablet form. The dosage and frequency are determined by the study team based on safety and effectiveness.

Hormone therapies are administered as follows: letrozole, tamoxifen, anastrozole, and exemestane are taken orally, while fulvestrant is given as an injection.

4 Regular Monitoring

Regular check-ups are scheduled to monitor health and response to treatment. This includes blood tests and imaging studies.

Adverse effects are recorded and managed according to the study protocol.

5 Evaluation of Treatment Response

The effectiveness of the treatment is evaluated through various measures such as objective response rate and progression-free survival.

Adjustments to the treatment plan may be made based on these evaluations.

6 Completion and Follow-up

Upon completion of the treatment phase, a final assessment is conducted to evaluate overall health and treatment outcomes.

Long-term follow-up may be required to monitor any delayed effects of the treatment.

Who Can Join the Study?

Provide written, informed consent to participate in the study and follow the study procedures.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
Have enough time passed since previous treatments: more than 14 days from any prior hormone therapy, 14 days from radiation therapy (28 days for brain treatments), and more than 14 days or 5 half-life periods from the last dose of any experimental cancer drug.
Female patients must meet one of the following: have had both ovaries removed, be 60 years or older with no periods for at least a year, be under 60 with hormone levels showing post-menopausal status, or be willing to take a hormone treatment if pre- or peri-menopausal.
Pre- and peri-menopausal female patients must have a negative pregnancy test before starting the study and regularly during the study.
Pre- or peri-menopausal female patients must agree to use a highly effective birth control method during the study and for 6 months after the last dose of the study drug. If not possible, they must use two other effective methods together.
Male patients must agree to use a highly effective birth control method with their female partners during the study and for 3 months after the last dose. If not possible, they must use two other effective methods together. They must also not donate sperm during this time.
Have proper functioning of major organs and blood as determined by screening tests.
Be at least 18 years old at the time of giving consent.
Be willing to provide a sample of tumor tissue for research purposes. If a new biopsy is not safe, a previous sample may be used.
Have a confirmed diagnosis of breast cancer that has returned or spread and cannot be cured with current treatments.
Have had at least two previous hormone treatments for cancer that has returned or spread.
Have received a CDK4/6 inhibitor with hormone therapy for cancer that has returned or spread.
Have a tumor that is hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-), as confirmed by local testing.
Have at least one measurable tumor as defined by specific criteria, which means it can be measured using imaging techniques like CT or MRI.
Be suitable for the hormone therapy chosen by the study doctor and not have received this therapy before for cancer that has returned or spread.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied cannot participate.
Patients who are not able to follow the study procedures or take the study medication as required will be excluded.
Patients who have a medical condition that could make it unsafe for them to participate in the study will not be allowed.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have an allergy or severe reaction to any of the study medications will be excluded.
Patients who have a history of certain heart problems may not be able to join the study.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study, will not be included.

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
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Hospital Universitario De Jaen	Jaen	Spain
Hospital Cuf Descobertas S.A.	Lisbon	Portugal
Hospital Universitario Basurto	Bilbao	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Champalimaud Clinical Centre	Lisbon	Portugal
Hospital Universitario De Cruces	Barakaldo	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hiaeibwb Vqba dgtyupcw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Portugal	Recruiting	01.10.2024
Spain	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Alisertib is a medication being studied for its potential to treat certain types of breast cancer. It is being tested in combination with other treatments to see if it can help stop or slow the growth of cancer cells. Researchers are trying to find the best dose that is both safe and effective for patients.

Endocrine Therapy is a treatment used to block or lower the amount of hormones in the body to slow down or stop the growth of cancer. In this study, it is used alongside alisertib to see if the combination can improve outcomes for patients with hormone receptor-positive, HER2-negative breast cancer.

Investigated diseases:

Hormone receptor positive HER2 negative breast cancer

Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Recurrent or Metastatic Breast Cancer (MBC) – This type of breast cancer is characterized by the presence of hormone receptors, meaning the cancer cells grow in response to hormones like estrogen or progesterone. It is negative for the HER2 protein, which means it does not overexpress the HER2 gene. This cancer can recur or spread to other parts of the body, known as metastasis. The progression involves the cancer cells continuing to grow and potentially spreading to other organs. It is often managed by targeting the hormone receptors to slow or stop the growth of the cancer cells. The disease can vary in its progression, with some cases remaining stable for extended periods.

Trial ID:

2024-511497-79-00

Protocol code:

PUMA-ALI-1201

NCT ID:

NCT06369285

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Alisertib with Hormone Therapy for Patients with HR+, HER2- Recurrent or Metastatic Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?