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Study of Capivasertib and Paclitaxel for Patients with Advanced or Metastatic Triple-Negative Breast Cancer

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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 a type of breast cancer known as Triple-Negative Breast Cancer (TNBC). This form of cancer is called "triple-negative" because it does not have any of the three common receptors known to fuel most breast cancer growth. The study is testing a new treatment combination of two drugs: Capivasertib and Paclitaxel. Capivasertib is taken as a film-coated tablet, while Paclitaxel is given as an infusion directly into the bloodstream. Some participants will receive a placebo instead of Capivasertib, but all will receive Paclitaxel.

The purpose of the study is to determine how effective the combination of Capivasertib and Paclitaxel is compared to a placebo and Paclitaxel in treating patients with locally advanced or metastatic TNBC. "Locally advanced" means the cancer has spread to nearby tissues or lymph nodes, and "metastatic" means it has spread to other parts of the body. The study will monitor participants over time to see how long they live and how their cancer responds to the treatment.

Participants in the study will be randomly assigned to receive either the Capivasertib and Paclitaxel combination or the placebo and Paclitaxel. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure the results are unbiased. The trial will continue until enough data is collected to understand the treatment's effectiveness and safety. The main goal is to see if the new treatment can help patients live longer and manage their cancer more effectively.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation is confirmed based on specific criteria, including a diagnosis of triple-negative breast cancer that is either locally advanced or metastatic.
Eligibility is determined through a review of medical history and recent tumor tissue samples.
Step 2
Treatment initiation
The treatment phase begins with the administration of medications. The study involves two groups: one receiving capivasertib and paclitaxel, and the other receiving a placebo and paclitaxel.
Capivasertib is provided in the form of film-coated tablets for oral use. Paclitaxel is administered intravenously.
Step 3
Medication schedule
The dosage and frequency of capivasertib and paclitaxel are determined by the study protocol. The specific schedule will be communicated during the treatment phase.
The duration of medication administration is aligned with the study's objectives and will continue as per the trial's design.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the treatment's effectiveness and safety. This includes evaluations of overall survival and progression-free survival.
Additional assessments involve measuring response rates, duration of response, and clinical benefit rate.
Step 5
Safety evaluations
Safety is evaluated through the collection of vital signs, clinical chemistry, hematology, and glucose metabolism parameters.
Electrocardiograms (ECGs) are performed to monitor heart function, and any adverse events are documented.
Step 6
Quality of life assessments
Quality of life is assessed using specific questionnaires designed for breast cancer patients, including the EORTC QLQ BR23 and EORTC QLQ C30.
These assessments help understand the impact of treatment on daily life and overall well-being.
Step 7
Completion of the study
The study is estimated to conclude by March 18, 2025. Participants will be informed about the study's outcomes and any further steps if applicable.
Final evaluations will be conducted to summarize the treatment's impact and gather comprehensive data for analysis.

Who can join the trial?

8 criteria

The patient must have a type of breast cancer called Triple-negative Breast Cancer (TNBC), confirmed by examining a recent tumor tissue sample.
The cancer must be metastatic (spread to other parts of the body) or locally advanced (grown into nearby areas). If the cancer can be removed with surgery to cure it, the patient cannot join the study.
The patient must have an ECOG/WHO Performance Status of 0-1, which means they are fully active or have some symptoms but can still do light work.
The patient must have cancer that can be measured using specific guidelines called RECIST 1.1, or have certain types of bone lesions that can be seen on a CT or MRI scan.
A FFPE tumor sample from the primary or recurrent cancer must be available. FFPE stands for "formalin-fixed, paraffin-embedded," which is a way of preserving tissue samples.
The patient must be within certain age ranges, specifically adults.
Both female and male patients can participate in the study.
The study may include individuals considered part of a vulnerable population, which means they might need extra protection or care.

Who cannot join the trial?

5 criteria

Patients who do not have triple-negative breast cancer cannot participate. This type of cancer does not have three common receptors known to fuel most breast cancer growth.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of patients.
Patients who are not female or male cannot participate. The study includes both genders.
Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or others who need special protection.

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Verified sites

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Hospital De La Santa Creu I Sant Pau
Barcelona, Spain

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Investigated drugs

Capivasertib
is a medication being studied for its potential to treat triple-negative breast cancer. It is being tested in combination with another drug to see if it can improve the overall survival of patients with this type of cancer.
Paclitaxel
is a chemotherapy drug commonly used to treat various types of cancer, including breast cancer. In this study, it is used in combination with another medication to evaluate its effectiveness in treating triple-negative breast cancer.

What is already known about the treatment

Capivasertib
Capivasertib is administered orally and is currently being studied in clinical trials for its effectiveness in treating triple-negative breast cancer. It is not yet widely used in standard medical practice but shows promise in ongoing research. The main therapeutic indication is for patients with locally advanced or metastatic triple-negative breast cancer. Capivasertib works by inhibiting specific enzymes involved in cancer cell growth and survival, particularly targeting the AKT pathway, which is crucial for cell proliferation. It is classified as a kinase inhibitor in pharmacology.
Paclitaxel
Paclitaxel is administered intravenously and is a well-established medication in the treatment of various cancers, including triple-negative breast cancer. It is widely recognized in medical literature and is commonly used in chemotherapy regimens. The main therapeutic indication is for treating different types of cancer, including breast cancer. Paclitaxel works by stabilizing microtubules, thereby inhibiting cell division and promoting cancer cell death. It is classified as a mitotic inhibitor in pharmacology.

Investigated diseases

Triple-negative Breast Cancer – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The cancer cells in triple-negative breast cancer do not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. It tends to grow and spread more quickly than other types of breast cancer. This type of cancer is more likely to affect younger women and those with a BRCA1 gene mutation. It is often diagnosed at a higher grade and stage, indicating a more advanced disease.