Study of Capivasertib and Fulvestrant for Patients with High-Risk Lobular Breast Cancer

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What is this study about?

This clinical trial is focused on studying treatments for primary high-risk lobular breast cancer. The study will evaluate the effectiveness of two medications: Fulvestrant, which is a solution for injection, and Capivasertib, which is a film-coated tablet. Fulvestrant works as a competitive estrogen receptor antagonist, while Capivasertib is a potent and selective oral inhibitor of all three isoforms of the serine/threonine kinase AKT. The purpose of the study is to assess the ability of these treatments to stop the cancer cell cycle completely.

Participants in the study will receive either Fulvestrant alone or a combination of Fulvestrant and Capivasertib. The study will last for approximately 10 weeks, during which the effects of the treatments on the cancer will be closely monitored. The main goal is to see if the treatments can reduce the activity of a protein called Ki67 to less than 2.7%, which indicates a complete cell cycle arrest. This will be assessed by examining breast tissue samples.

Secondary goals of the study include evaluating the absence of any remaining cancer cells in the breast and lymph nodes after treatment, known as a pathological complete response. The study will also look at how long participants remain free from invasive disease and overall survival rates. These outcomes will help determine the effectiveness of the treatments in managing high-risk lobular breast cancer.

1 joining the study

Upon joining the study, the patient will begin the trial with a focus on treating primary high-risk lobular breast cancer.

The study aims to evaluate the effectiveness of two medications: fulvestrant and capivasertib.

2 medication administration

The patient will receive fulvestrant as a 250 mg solution for injection. This medication is administered intramuscularly.

Additionally, the patient will take capivasertib in the form of film-coated tablets, which are taken orally.

3 treatment duration

The treatment period is approximately 10 weeks. During this time, the patient will be monitored for the primary endpoint, which is a reduction in the Ki67 marker to less than 2.7%.

4 monitoring and assessment

Throughout the trial, the patient’s response to the treatment will be assessed through various endpoints, including the absence of tumor cells in resected specimens and overall survival.

The study will also evaluate the patient’s invasive disease-free survival, which measures the time until any recurrence or new cancer development.

5 completion of the trial

The trial is expected to conclude by October 15, 2026. The patient’s progress and outcomes will be documented and analyzed to determine the effectiveness of the treatment.

Who Can Join the Study?

The patient must provide written informed consent before starting any specific procedures related to the study. This means they agree to participate and understand what the study involves.
The patient must be able to attend scheduled visits, receive treatment, and participate in follow-up appointments.
The patient must have normal heart function as confirmed by local medical guidelines.
Laboratory tests must show:
- Enough white blood cells, specifically a type called neutrophils, which should be at least 1.5 x 10⁹ per liter.
- Enough platelets, which help with blood clotting, at least 100 x 10⁹ per liter.
- Hemoglobin, a protein in red blood cells, should be at least 10 grams per deciliter.
- Liver function tests should show:
  - Total bilirubin, a substance made by the liver, should be less than 1.25 times the upper limit of normal (ULN).
  - AST and ALT, enzymes that indicate liver health, should be 1.5 times the ULN or less.
  - Alkaline phosphatase, another enzyme, should be 2.5 times the ULN or less.
- Blood sugar control, measured by HbA1c, should be less than 8.0%.
- Kidney function should show creatinine, a waste product, less than 1.25 times the ULN or a creatinine clearance of at least 50 ml/min.
The patient must complete a full assessment of their cancer before starting treatment, following standard recommendations.
The patient must be a postmenopausal woman, which means:
- She is 60 years or older, or
- She is under 60 but has not had a menstrual period for at least 12 months for reasons other than pregnancy.
- She has had both ovaries removed.
A negative pregnancy test is required within 14 days before starting the study for women 50 years or younger who have not had both ovaries removed.
The patient must have untreated lobular breast cancer, which is a specific type of breast cancer. If cancer is present in both breasts, both must be of the lobular type.
The patient must be willing and able to provide a sample of their tumor tissue, which was taken before starting treatment.
The cancer must be confirmed as HER2-negative and HR-positive, which are specific characteristics of the cancer cells. HER2-negative means the cancer does not have high levels of a protein called HER2, and HR-positive means the cancer grows in response to hormones.
The patient must have a high risk of cancer coming back, defined by specific tumor size and lymph node involvement.
There must be no signs of cancer spreading to distant parts of the body.
The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
The patient should have an estimated life expectancy of at least 5 years, regardless of their breast cancer diagnosis.

Who Cannot Join the Study?

Patients who do not have primary high-risk lobular breast cancer cannot participate. This type of cancer starts in the lobules, which are the glands that produce milk in the breast, and is considered high-risk due to its potential to spread or grow quickly.
Only females are eligible to participate, so males cannot join the study.
Participants must be within certain age ranges, specifically adults and older adults. This means children and teenagers are not eligible.
Individuals who are part of a vulnerable population, such as those who might have difficulty understanding the study or making decisions, are not included.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Klinikum Oldenburg AöR	Oldenburg In Holstein	Germany
Klinikum Frankfurt Hoechst GmbH	Frankfurt	Germany
Haematologie-Onkologie im Zentrum MVZ GmbH	Augsburg	Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH	Schweinfurt	Germany
Kreiskrankenhaus Torgau Johann Kentmann gGmbH	Torgau	Germany
GPR Gesundheits und Pflegezentrum Ruesselsheim gGmbH	Ruesselsheim Am Main	Germany
Mammazentrum Hamburg MVZ GbR	Hamburg	Germany
Praxisklinik Krebsheilkunde Fuer Frauen	Berlin	Germany
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR	Freiburg Im Breisgau	Germany
Robert Bosch Gesellschaft fuer medizinische Forschung mbH	Stuttgart	Germany
Onkologie Rheinsieg Praxisnetzwerk	Troisdorf	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Klinikum Worms gGmbH	Worms	Germany
Klinikum Suedstadt Rostock	Rostock	Germany
Saarland University Hospital	Homburg	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Klinikum Kassel GmbH	Kassel	Germany
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH	Bamberg	Germany
Studienzentrum Onkologie Ravensburg GmbH	Ravensburg	Germany
St. Elisabeth-Krankenhaus Leipzig	Leipzig	Germany
Institut fuer Diabetesforschung Muenster GmbH	Munster	Germany
Kozoeepguticl Rahhffdqxq Gdmt	Reutlingen	Germany
Unutdlanqboqppmlvavzv Entop Akh	Essen	Germany
Hsdeuxyvtykqjsvp im Majpjpl	Bremen	Germany
Omkthlzugoax Sgihyzeqizoivdtmx	Bielefeld	Germany
Kapso Stg Pmzgez Grcb	Dortmund	Germany
Mtusoj Hmgihjqn Wtjddo	Witten	Germany
Kvjjkwba Ekbypbcrikwrkqqcpmtrifzx Hrhxqxytgjdmzhqsb	Essen	Germany
Jdjsfaoret Gzns Jcccxhjkxtulawcbeahbel	Bonn	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	15.07.2024

Trial locations

Investigated drugs:

Capivasertib is a medication being studied for its potential to help stop the growth of cancer cells. It works by targeting specific proteins that are involved in the cell cycle, which is the process that controls cell division and growth. In this trial, capivasertib is being tested to see if it can enhance the effects of another medication, fulvestrant, in treating high-risk lobular breast cancer.

Fulvestrant is a medication used to treat certain types of breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. In this study, fulvestrant is being used alone and in combination with capivasertib to evaluate its effectiveness in stopping cancer cell growth in patients with high-risk lobular breast cancer.

Investigated diseases:

Invasive lobular breast carcinoma

Primary High-Risk Lobular Breast Cancer – This is a type of breast cancer that originates in the lobules, which are the glands responsible for milk production. It is characterized by cancer cells that invade surrounding breast tissue and potentially spread to other parts of the body. Lobular breast cancer is often more difficult to detect on mammograms compared to other types of breast cancer due to its growth pattern. The term “high-risk” indicates that the cancer has features that may lead to a more aggressive progression. This type of cancer may not form a distinct lump, making it challenging to diagnose early. It is important to monitor for changes in breast texture or appearance, as these can be subtle indicators of the disease.

Trial ID:

2023-509292-17-00

Protocol code:

GBG 118

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Capivasertib and Fulvestrant for Patients with High-Risk Lobular Breast Cancer

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