N/A
Completed N=1,250
Palbociclib in Real World Practice
Source: ClinicalTrials.gov NCT03280303 ↗Enrolled (actual)
1,250
Serious AEs
32.2%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants According to Real-World Tumor Response — 72; 310; 499; 223 Participants
Summary
This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants According to Real-World Tumor Response |
72; 310; 499; 223; 146; 58 | — |
| PRIMARY Real-World Tumor Response Rate |
30.6; 33.7; 22.2 | — |
| PRIMARY Real World Progression Free Survival |
18.8; 21.0; 13.2 | — |
| PRIMARY Overall Survival |
42.3; 48.5; 37.2 | — |
| PRIMARY Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only |
0.7 | — |
| PRIMARY ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only |
0.7 | — |
| PRIMARY ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only |
0.7 | — |
| PRIMARY ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only |
0.7 | — |
| PRIMARY ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only |
0.8 | — |
| PRIMARY ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only |
0.8 | — |
| PRIMARY ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only |
0.8 | — |
| PRIMARY ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only |
0.8 | — |
| PRIMARY ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only |
0.7 | — |
| PRIMARY ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only |
0.8 | — |
| PRIMARY ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only |
0.7 | — |
| PRIMARY ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only |
0.9 | — |
| PRIMARY ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only |
0.9 | — |
| PRIMARY ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only |
0.9 | — |
| PRIMARY ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only |
0.6 | — |
| PRIMARY ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only |
0.4 | — |
| PRIMARY ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only |
0.5 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only |
13.4 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only |
13.3 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only |
13.4 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only |
13.4 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only |
13.5 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only |
13.7 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only |
13.7 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only |
13.6 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only |
13.4 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only |
13.4 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only |
13.5 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only |
13.3 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only |
13.1 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only |
13.3 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only |
14.1 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only |
13.5 | — |
| PRIMARY Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only |
13.0 | — |
| PRIMARY Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline |
3.5; -1.9; -0.9; -4.5; -1.7; 0.5 | — |
| PRIMARY Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline |
2.5; -1.8; -3.1; -5.1; -1.9; 0.1 | — |
| PRIMARY Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline |
2.5; 0.4; -3.5; -4.7; -1.4; 0.8 | — |
| PRIMARY Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only |
17.6 | — |
| PRIMARY Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only |
17.6 | — |
| PRIMARY Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only |
17.7 | — |
| PRIMARY Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only |
17.6 | — |
| PRIMARY Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only |
17.6 | — |
| PRIMARY Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only |
17.6 | — |
| PRIMARY Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only |
17.4 | — |
| PRIMARY Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only |
17.5 | — |
| PRIMARY Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only |
17.6 | — |
| PRIMARY Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only |
17.7 | — |
| PRIMARY Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only |
17.6 | — |
| PRIMARY Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only |
17.5 | — |
| PRIMARY Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only |
17.3 | — |
| PRIMARY Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only |
17.5 | — |
| PRIMARY Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only |
17.3 | — |
| PRIMARY Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only |
17.3 | — |
| PRIMARY Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only |
16.5 | — |
| PRIMARY Number of Participants With Adverse Events |
1123 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
403 | — |
| PRIMARY Number of Participants With Any Clinical Laboratory Abnormalities |
1170 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years or older.
- Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or 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.
- Physician has determined that treatment with palbociclib is indicated.
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per standard of care practice at the site.
Exclusion Criteria
- Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment.
- Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study).
- Patients on active treatment for malignancies other than ABC at the time of enrollment.
- Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.
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Data sourced from ClinicalTrials.gov (NCT03280303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.