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Study on Alpelisib and Fulvestrant for Advanced Breast Cancer in Patients with PIK3CA Mutation and Hormone-Receptor Positive, HER2 Negative Tumors

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What is this study about?

This clinical trial is focused on studying advanced breast cancer that is hormone-receptor positive and HER2 negative, with a specific mutation known as PIK3CA. The study involves a combination treatment using two medications: fulvestrant and alpelisib (also known by its code name, BYL719). The purpose of the study is to explore the effectiveness of this combination treatment in patients whose cancer has progressed after previous therapy with fulvestrant.

Participants in the study will receive the treatment orally in the form of film-coated tablets. The study will last for a period of up to 52 weeks. During this time, the effects of the treatment will be monitored to assess how well it works in controlling the cancer and to evaluate any side effects. The study will also look into how the treatment impacts the quality of life of the participants and will gather information on how the body processes the medication.

The trial aims to provide valuable insights into the potential benefits of combining fulvestrant and alpelisib for treating this specific type of breast cancer. It will also help in understanding the management of side effects, such as alpelisib-induced hyperglycemia, which is an increase in blood sugar levels. The study will contribute to the knowledge of how these medications can be used effectively in patients with the PIK3CA mutation.

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.

Eligibility criteria include a confirmed diagnosis of advanced breast cancer with specific characteristics, such as hormone-receptor positive and HER2 negative status, and a PIK3CA mutation.

2 treatment initiation

The treatment involves a combination of two medications: fulvestrant and alpelisib.

Fulvestrant is administered as an injection, typically given once a month.

Alpelisib is taken orally in the form of film-coated tablets. The dosage may vary, with options including 150 mg, 200 mg, or a combination of 50 mg and 200 mg tablets.

3 ongoing treatment and monitoring

Regular monitoring is conducted to assess the effectiveness of the treatment and to manage any side effects.

Progression-free survival is a key measure, tracking the time from enrollment to disease progression or any cause of death.

Additional assessments include evaluating the objective response rate, clinical benefit rate, and duration of response.

4 safety and quality of life assessments

Safety and tolerability of the treatment are continuously evaluated.

Quality of life and patient-reported outcomes are assessed to understand the impact of the treatment on daily living.

Specific attention is given to managing and resolving any alpelisib-induced hyperglycemia.

5 completion of study participation

The study is estimated to conclude by March 2026.

Upon completion, final assessments are conducted to evaluate overall survival and other long-term outcomes.

Who Can Join the Study?

  • Adults, both women and men, aged 18 or older, with a confirmed diagnosis of breast cancer that has come back or spread to other parts of the body and cannot be treated with surgery or radiation to cure it. Women must be postmenopausal, have had their ovaries removed, or be receiving a medication called a luteinizing hormone-releasing hormone (LHRH) analogue. Men must also receive an LHRH-analogue.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
  • Must have signed a document showing they understand the study and agree to participate.
  • Must have a confirmed diagnosis of breast cancer with more than 10% of cells showing estrogen receptor (ER) or progesterone receptor (PR) expression. The cancer must not have a protein called HER2. If HER2 status is unknown, testing must be done.
  • Must have previously been treated with a drug called fulvestrant and shown disease progression. If fulvestrant was stopped, it should not have been more than 12 weeks ago. If fulvestrant was used with a CDK4/6 inhibitor as the last treatment, the patient must have progressed during or shortly after stopping another treatment called adjuvant treatment with an (NS)AI.
  • Must have been treated with a CDK4/6 inhibitor in the advanced stage of the disease.
  • Must have a specific change in the cancer called an activating PIK3CA mutation, preferably found in a metastasis. If a sample from a metastasis is not available, testing can be done on the original tumor or stored tumor material.
  • Must have evaluable disease, meaning the cancer can be measured or assessed according to specific guidelines. If the disease is only in the form of fluid buildup (ascites or pleural effusion), the patient is not considered evaluable. Bone-only disease is considered evaluable.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which indicates how well the patient is able to carry out daily activities.
  • Must have adequate function of organs and bone marrow, which includes specific levels of blood cells and kidney and liver function.
  • Must have recovered from any immediate side effects of previous cancer treatments or surgeries, except for side effects that are not considered a safety risk by the study doctor.

Who Cannot Join the Study?

  • Patients who have not previously been treated with a CDK 4/6 inhibitor. A CDK 4/6 inhibitor is a type of medication used to treat certain types of breast cancer.
  • Patients who do not have a PIK3CA mutation in their tumor. A PIK3CA mutation is a change in a specific gene that can affect how cancer grows.
  • Patients who are not pre- or postmenopausal women or men. This means the study is only for women who have gone through menopause or have not yet reached it, and for men.
  • Patients who do not have HR+HER2- advanced breast cancer. This is a type of breast cancer that tests positive for hormone receptors (HR+) and negative for a protein called HER2.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Frisius Heerenveen The Netherlands

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Amphia Hospital Breda The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Ziekenhuis Amstelland Amstelveen The Netherlands
Maxima Medisch Centrum Veldhoven The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Deventer Ziekenhuis Deventer The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Gelre Hospitals Zutphen The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Rvabfqrls Zqhavfirjs Svfzpkwsb Arnhem The Netherlands
Swoaxpgyr Mpxajhh Zgfcnczsim Groningen The Netherlands
Ajyciehh Df Rwcwez Zakhhobjmr Bygw Goes The Netherlands
Acoybdgab Uiy Amsterdam The Netherlands
Shl Eruffgjha Hpetodrb Tyyilxd Tilburg 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 recruiting
02.06.2022

Trial locations

Investigated drugs:

Fulvestrant is a medication used in the treatment of hormone-receptor positive advanced breast cancer. It works by blocking the effects of estrogen in the body, which can help slow down or stop the growth of certain types of breast cancer cells that need estrogen to grow.

Alpelisib is a medication used in combination with other treatments for advanced breast cancer. It specifically targets and inhibits a protein called PI3K, which is involved in the growth and survival of cancer cells. This medication is particularly used for tumors that have a specific mutation known as PIK3CA, which can make the cancer more aggressive.

Investigated diseases:

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 or seen on an X-ray. 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 tumors growing slowly and others rapidly. Hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer is a subtype that relies on hormones to grow but does not overexpress the HER2 protein. This type of cancer may progress after initial treatments, necessitating further therapeutic strategies. Understanding the genetic mutations, such as PIK3CA, can influence the progression and treatment approach for this disease.

Trial ID:
2024-514965-20-00
Protocol code:
BOOG 2021-01
NCT ID:
NCT05392608
Trial Phase:
Therapeutic exploratory (Phase II)

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