The objective of this non-interventional multicenter study is to provide prospective, observational data on patients initiating treatment with palbociclib combination to contribute to the knowledge of HR+ HER2-metastatic/locally advanced Breast Cancer (BC) disease management, its treatment pattern, clinical outcomes and quality of life (QoL) in the routine clinical practice in Africa and Middle East countries .
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥18 years or older with diagnosis of adenocarcinoma of the breast with evidence of metastatic /locally advanced disease not amenable to treatment with curative intent.
. Documented HR+ (ER+ and/or PR+) tumor based on local standards
. Documented HER2- tumor based on local standards
. Will initiate treatment with palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s), as first or second line therapy for metastatic/locally advanced BC at enrollment
. Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits
. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study tracked how long patients with HR-positive, HER2-negative metastatic breast cancer stayed progression-free at 6, 12, 18, and 24 months after starting palbociclib — what did the results actually show, and how do those numbers compare to what I might expect from starting palbociclib now?
2Since this was an observational study rather than a randomized trial, it was watching what happened to real patients in practice rather than testing a new treatment — does that mean the findings reflect outcomes I'm more likely to see in a real-world setting, and how should I weigh that against results from controlled clinical trials?
3The study looked at palbociclib in combination with other drugs — which combinations were most common in this study, and based on these real-world results, which combination would you recommend for my specific situation and why?
4The trial also tracked 1-year and 2-year survival rates — can you walk me through what those survival figures looked like and whether my own health profile would put me in a better or worse position than the average patient in this study?
5Since this study is now completed and was observational in nature, are there newer or ongoing trials building on these findings that might be worth considering alongside standard palbociclib-based treatment options for my case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation
Timeframe: At 6 months from the date of palbociclib initiation in routine clinical practice
2
Percentage of Participants Who Were Progression Free at 12 Months Post Palbociclib Initiation
Timeframe: At 12 months from the date of palbociclib initiation in routine clinical practice
3
Percentage of Participants Who Were Progression Free at 18 Months Post Palbociclib Initiation
Timeframe: At 18 months from the date of palbociclib initiation in routine clinical practice
4
Percentage of Participants Who Were Progression Free at 24 Months Post Palbociclib Initiation
Timeframe: At 24 months from the date of palbociclib initiation in routine clinical practice
5
Percentage of Participants Who Were Alive at 1 Year Post Palbociclib Initiation
Timeframe: At 1 year from the date of palbociclib initiation in routine clinical practice
6
Percentage of Participants Who Were Alive at 2 Years Post Palbociclib Initiation
Timeframe: At 2 year from the date of palbociclib initiation in routine clinical practice