Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt
Trial assesses CDK4/6 inhibitors for advanced breast cancer in Egypt.
Plain English Summary
Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt is a Phase 4 clinical trial sponsored by Beni-Suef University studying Breast Cancer. This trial tests how well CDK4/6 inhibitors work when combined with standard hormone therapy for advanced breast cancer. It is for patients in Egypt with hormone receptor-positive, HER2-negative advanced breast cancer. Participation involves receiving one of three CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) along with standard endocrine therapy. Alternatives may include other cancer treatments or clinical trials, depending on the patient's specific situation and doctor's recommendation. The trial aims to enroll 206 participants.
Official Summary
Cyclin-dependent kinases CDK4/6 inhibitors (CDK4/6i) combined with ET are considered the standard of care for first-line therapy of patients with hormone receptor positive, HER2 negative, advanced BC (HR+/HER2-ABC). CDK4/6 inhibitors are the first ones that were approved by the FDA for clinical treatment. These inhibitors specifically inhibit CDK4/6 and show limited toxicity to normal cells. There are three FDA-approved CDK4/6 inhibitors, and they are palbociclib produced by Pfizer, ribociclib produced by Novartis, and abemaciclib produced by Eli Lilly. Palbociclib is the first and most popular CDK4/6 inhibitor, which reached $2.135 billion in global sales in 2016. Ribociclib is very similar to palbociclib in structure, but abemaciclib is quite different. In vitro studies indicated that palbociclib has an almost equivalent inhibition effect on CDK4 and CDK6, while abemaciclib and ribociclib are more potent against CDK4 than CDK6. CDKs are protein kinases that phosphorylate cellular proteins, causing their activation or inactivation during the G1 cell cycle phase. In a dysregulated cell cycle, CDK4/6 proteins bind to cyclin D1 to form an activated complex, which then phosphorylates and inactivates tumor suppressor retinoblastoma protein and releases E2F transcription factors, thus resulting in cell cycle progression and cancer cell proliferation. Introducing highly selective inhibitors of this pathway into clinical practice as CDK4/6 inhibitors (CDKi), which act by blocking the cyclin D1/CDK4/6 complex and inhibit cell cycle progression to the S phase and cancer proliferation, is very promising. These novel molecular mechanisms provide a theoretical basis for combination therapy with CDK4/6 inhibitors. For instance, CDK4/6 inhibitors combined with the hormone receptor antagonist letrozole have been applied for BC therapy. Many other combination therapies involving CDK4/6 inhibitors are currently under clinical trials for a variety of diseases, including anti-cancer t
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with confirmed invasive breast cancer that is hormone receptor-positive and HER2-negative, and has spread (metastatic). Patients must have complete medical records from January 2020 to December 2024. Patients younger than 18 years old cannot join. Patients who are critically ill with their cancer (visceral crisis) cannot join. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
Progression-free survival means how long patients live without their cancer getting worse, and overall survival means how long they live in total. These measures help determine if the treatment is eff The specific primary outcome measures are: 1- Progression free survival (PFS). (1 year); 2-Overall Survival (1 year); Incidence of Treatment-Related Adverse Events (1 year); Economic outcomes (1 year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial matters because it evaluates the effectiveness and cost of CDK4/6 inhibitors, a crucial treatment for advanced breast cancer, in the Egyptian population, addressing a potential gap in acces This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
The market for CDK4/6 inhibitors is substantial, with several major pharmaceutical companies involved; this trial's focus on pharmacoeconomics in Egypt could signal opportunities for market penetratio This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor about the specific CDK4/6 inhibitor you would receive and how it is given. Discuss potential side effects and how they will be managed. Understand how your medical records will be used and protected. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 206 participants
Interventions
- DRUG: Palbocicilib — Patient receive standard endocrine therapy (ETH) in combination with Palbociclib. palbociclib administered according to standard dosing regimen (125mg /day ) for 3 consecutive weeks , one week off per month
- DRUG: Ribociclib — Ribociclib administered according to standard dosing regimen (600 mg / day ) for 3 consecutive weeks , one week off per month
- DRUG: Abemaciclib — Abemaciclib administered according to standard dosing regimen (300 mg / day ) for 3 consecutive weeks , one week off per month
Primary Outcomes
- 1- Progression free survival (PFS). (1 year)
- 2-Overall Survival (1 year)
- Incidence of Treatment-Related Adverse Events (1 year)
- Economic outcomes (1 year)
Full Eligibility Criteria
* Inclusion criteria * Eligible patients will be who with histologically confirmed invasive breast carcinoma with HR positive and HER2 negative phenotype and clinical or radiological evidence of metastasis. * Only patients with complete medical records from January 2020 December 2024 will be included. * Exclusion criteria * Exclusion criteria will be devised to ensure the collection of authentic real world data excluding patients those with insufficient clinical documentation, unknown clinical outcomes, or those who transferred to another treatment center during their therapy course. * Females younger than 18 years will be excluded. * Patients in visceral crisis .
Trial Locations
- Gustave Roussy International Hospital in Egypt., Cairo, Cairo Governorate, Egypt
Frequently Asked Questions
What is clinical trial NCT07487129?
NCT07487129 is a Phase 4 INTERVENTIONAL study titled "Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt." It is currently completed and is sponsored by Beni-Suef University. The trial targets enrollment of 206 participants.
What conditions does NCT07487129 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT07487129?
The interventions being studied include: Palbocicilib (DRUG), Ribociclib (DRUG), Abemaciclib (DRUG). Patient receive standard endocrine therapy (ETH) in combination with Palbociclib. palbociclib administered according to standard dosing regimen (125mg /day ) for 3 consecutive weeks , one week off per month
What does Phase 4 mean for NCT07487129?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT07487129?
This trial is currently "Completed." It started on 2024-08-25. The estimated completion date is 2025-12-20.
Who is sponsoring NCT07487129?
NCT07487129 is sponsored by Beni-Suef University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07487129?
The trial aims to enroll 206 participants. The trial status is completed.
How is NCT07487129 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07487129?
The primary outcome measures are: 1- Progression free survival (PFS). (1 year); 2-Overall Survival (1 year); Incidence of Treatment-Related Adverse Events (1 year); Economic outcomes (1 year). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07487129 being conducted?
This trial is being conducted at 1 site, including Cairo, Cairo Governorate (Egypt).
Where can I find official information about NCT07487129?
The official record for NCT07487129 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07487129. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07487129 testing in simple terms?
This trial tests how well CDK4/6 inhibitors work when combined with standard hormone therapy for advanced breast cancer. It is for patients in Egypt with hormone receptor-positive, HER2-negative advanced breast cancer.
Why is this trial significant?
This trial matters because it evaluates the effectiveness and cost of CDK4/6 inhibitors, a crucial treatment for advanced breast cancer, in the Egyptian population, addressing a potential gap in acces
What are the potential risks of participating in NCT07487129?
Common side effects can include low white blood cell counts, which can increase the risk of infection, and fatigue. Other potential side effects may include nausea, diarrhea, hair loss, and mouth sores. The trial is not blinded, meaning both patients and doctors will know which treatment is being given, which could influence perceptions of effectiveness or side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07487129?
Ask your doctor about the specific CDK4/6 inhibitor you would receive and how it is given. Discuss potential side effects and how they will be managed. Understand how your medical records will be used and protected. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07487129 signal from an investment perspective?
The market for CDK4/6 inhibitors is substantial, with several major pharmaceutical companies involved; this trial's focus on pharmacoeconomics in Egypt could signal opportunities for market penetratio This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves receiving one of three CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) along with standard endocrine therapy. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.