Retrospective, Multicenter, Observational Study to Evaluate Real-World Effectiveness of Palbociclib Plus Endocrine Therapy in Japanese Patients With HR+/HER2- Advanced Breast Cancer in First Line or Second Line Settings
Real-world effectiveness of breast cancer drug combination in Japan
Plain English Summary
Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan is a Not Applicable clinical trial sponsored by Pfizer studying Breast Cancer. This study looks at how well a combination of drugs, palbociclib and endocrine therapy, works for advanced breast cancer in real-world patient care in Japan. It is for patients with HR+/HER2- advanced breast cancer who have received or are receiving this drug combination as a first or second treatment. Participation involves reviewing existing medical records; no new treatments or interventions are given as part of this study. Alternatives include other standard breast cancer treatments, chemotherapy, or participation in different clinical trials. The trial aims to enroll 693 participants.
Official Summary
This is a retrospective, multicenter, observational study in Japan by medical record review of advanced breast cancer (ABC) patients who have received palbociclib plus endocrine therapy (ET) as first line or second line setting. For the purposes of this study, analyses will be descriptive in nature. No formal hypothesis testing is planned.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients diagnosed with HR+/HER2- advanced breast cancer. Must be 20 years or older at the time of their advanced breast cancer diagnosis. Must have received palbociclib plus endocrine therapy as their first or second line of treatment. Patients who received chemotherapy as their first treatment are not eligible. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how long patients live without their cancer getting worse (Progression-Free Survival) when treated with palbociclib plus endocrine therapy, giving an idea of the treatment The specific primary outcome measures are: Real-World Progression-Free Survival (rwPFS) of palbociclib plus ET as first line treatment for HR+/HER2- ABC (15 December 2017 to 31 August 2023); rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC (15 December 2017 to 31 August 2023). 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 study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This study matters because it provides insights into how effective a common breast cancer treatment combination is in everyday clinical practice in Japan, helping to fill gaps in understanding beyond This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This observational study by Pfizer on a widely used breast cancer treatment combination in Japan signals continued interest in real-world data to support its established market position and potential The large enrollment target of 693 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if this study is relevant to your treatment and if your medical records will be used. Understand that your participation is based on past or current treatment, and no new study-related procedures will be performed on you. Your medical information will be reviewed anonymously to gather data on treatment effectiveness. The trial is being conducted at 20 sites. 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: OBSERVATIONAL
- Enrollment: 693 participants
Interventions
- DRUG: Palbociclib — Palbociclib plus ET as first-line/second-line treatment for hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) ABC
- DRUG: Endocrine therapy — Palbociclib plus ET as first-line/second-line treatment for HR+/HER2- ABC
Primary Outcomes
- Real-World Progression-Free Survival (rwPFS) of palbociclib plus ET as first line treatment for HR+/HER2- ABC (15 December 2017 to 31 August 2023)
- rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC (15 December 2017 to 31 August 2023)
Secondary Outcomes
- Landmark overall survival (OS) (defined from palbociclib initiation to death) of palbociclib plus ET as first line treatment for HR+/HER2- ABC (15 December 2017 to 31 August 2023)
- Landmark OS (defined from palbociclib initiation to death)of palbociclib plus ET as second line treatment for HR+/HER2- ABC (15 December 2017 to 31 August 2023)
- Landmark OS (defined from treatment initiation of first line to death) when palbociclib plus ET were used as second line treatment for HR+/HER2- ABC (15 December 2017 to 31 August 2023)
- Time to treatment discontinuation (TTD) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC (15 December 2017 to 31 August 2023)
- TTD of first subsequent treatment for HR+/HER2- ABC patients who were treated with palbociclib plus ET (15 December 2017 to 31 August 2023)
Full Eligibility Criteria
Inclusion Criteria: * Diagnosis of HR+/HER2- ABC * Age of 20 years or older at diagnosis of ABC * Patients that received palbociclib plus ET in the first line or second line * Patients who meet the criteria regarding the medical record below: * Patients with any medical records (regardless of palbociclib use) for more than 6 months from palbociclib initiation OR * Patients with any medical records for less than 6 months from palbociclib initiation AND who had specific events (death, disease progression, or treatment discontinuation of palbociclib due to adverse events) in the available records Exclusion Criteria: * Patients who received chemotherapy as first line treatment. * Patients who have previously participated or are participating in any interventional clinical trials that include investigational or marketed products. (Interventional clinical trials for early breast cancer and later line after palbociclib will be acceptable, Besides, patients participating in other investigator-initiated research or noninterventional studies can be included as long as their standard of care is not altered by the study.)
Trial Locations
- Nagoya University Hospital, Nagoya, Aichi-ken, Japan
- National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
- Japan Community Health care Organization Kurume General Hospital, Kurume, Fukuoka, Japan
- Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
- Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa-ken, Japan
- Kitasato University Hospital, Sagamihara, Kanagawa, Japan
- Tohoku University Hospital, Sendai, Miyagi, Japan
- Kaizuka City Hospital, Kaizuka, Osaka, Japan
- Osaka International Cancer Institute, Osaka, Osaka, Japan
- Osaka University Hospital, Suita, Osaka, Japan
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT05399329?
NCT05399329 is a Not Applicable OBSERVATIONAL study titled "Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan." It is currently completed and is sponsored by Pfizer. The trial targets enrollment of 693 participants.
What conditions does NCT05399329 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT05399329?
The interventions being studied include: Palbociclib (DRUG), Endocrine therapy (DRUG). Palbociclib plus ET as first-line/second-line treatment for hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) ABC
What does Not Applicable mean for NCT05399329?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05399329?
This trial is currently "Completed." It started on 2022-04-20. The estimated completion date is 2025-06-27.
Who is sponsoring NCT05399329?
NCT05399329 is sponsored by Pfizer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05399329?
The trial aims to enroll 693 participants. The trial status is completed.
How is NCT05399329 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05399329?
The primary outcome measures are: Real-World Progression-Free Survival (rwPFS) of palbociclib plus ET as first line treatment for HR+/HER2- ABC (15 December 2017 to 31 August 2023); rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC (15 December 2017 to 31 August 2023). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05399329 being conducted?
This trial is being conducted at 20 sites, including Nagoya, Aichi-ken; Matsuyama, Ehime; Kurume, Fukuoka; Sapporo, Hokkaido and 16 more sites (Japan).
Where can I find official information about NCT05399329?
The official record for NCT05399329 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05399329. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05399329 testing in simple terms?
This study looks at how well a combination of drugs, palbociclib and endocrine therapy, works for advanced breast cancer in real-world patient care in Japan. It is for patients with HR+/HER2- advanced breast cancer who have received or are receiving this drug combination as a first or second treatment.
Why is this trial significant?
This study matters because it provides insights into how effective a common breast cancer treatment combination is in everyday clinical practice in Japan, helping to fill gaps in understanding beyond
What are the potential risks of participating in NCT05399329?
The main risks are related to the known side effects of palbociclib and endocrine therapy, which can include low blood cell counts, fatigue, nausea, and hair loss. There is a risk that the cancer may progress despite treatment, or that side effects could lead to stopping the treatment. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05399329?
Ask your doctor if this study is relevant to your treatment and if your medical records will be used. Understand that your participation is based on past or current treatment, and no new study-related procedures will be performed on you. Your medical information will be reviewed anonymously to gather data on treatment effectiveness. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05399329 signal from an investment perspective?
This observational study by Pfizer on a widely used breast cancer treatment combination in Japan signals continued interest in real-world data to support its established market position and potential This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves reviewing existing medical records; no new treatments or interventions are given as part of this study. 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.
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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.