N/A
Completed N=847
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
Breast Cancer Metastatic
Source: ClinicalTrials.gov NCT05155566 ↗
Enrolled (actual)
847
Serious AEs
—
Results posted
Jan 2024
Primary outcomePrimary: Progression Free Rate at Month 6 — 93.4; 91.3 Percentage of participants
Summary
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Rate at Month 6 |
93.4; 91.3 | — |
| PRIMARY Progression Free Rate at Month 12 |
80.9; 76.3 | — |
| PRIMARY Progression Free Rate at Month 18 |
68.8; 66.2 | — |
| PRIMARY Progression Free Rate at Month 24 |
60.9; 56.1 | — |
| PRIMARY Objective Response Rate |
69.8; 67.3 | — |
| PRIMARY Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation |
95.0; 96.9 | — |
| PRIMARY Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation |
83.0; 88.8 | — |
| PRIMARY Clinical Benefit Rate |
94.2; 95.2 | — |
| PRIMARY Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib |
24.5; 23.2 | — |
| PRIMARY Survival Rate at Month 6 |
98.9; 99.6 | — |
| PRIMARY Survival Rate at Month 12 |
95.0; 96.9 | — |
| PRIMARY Survival Rate at Month 18 |
87.7; 91.2 | — |
| PRIMARY Survival Rate at Month 24 |
83.0; 88.8 | — |
| PRIMARY Time From Palbociclib Initiation to Initial Response Recorded |
3.2; 3.0 | — |
| PRIMARY Time From Palbociclib Initiation to Complete Response |
4.5; 4.0 | — |
| PRIMARY Time From Palbociclib Initiation to Partial Response |
3.2; 3.2 | — |
| PRIMARY Follow-up Time Since Palbociclib Initiation |
12.7; 10.7 | — |
| PRIMARY Number of Participants With Supportive Therapies |
246; 88; 232; 88; 100; 79 | — |
| PRIMARY Duration of Ongoing Palbociclib Treatment |
11.2; 8.5 | — |
| PRIMARY Duration of Discontinued Palbociclib Treatment |
8.0; 5.0 | — |
| PRIMARY Number of Participants According to Therapies Received Post Palbociclib Treatment |
0; 34; 0; 2; 0; 1 | — |
| PRIMARY Time From Palbociclib Initiation to First Dose Reduction |
3.7; 3.4 | — |
| PRIMARY Duration of Dose Interruption |
14.0; 21.0 | — |
| PRIMARY Duration of Cycle Delays |
24.5; 21.0 | — |
Eligibility Criteria
Physician inclusion criteria:
- Oncologist or gynecologist.
- Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria.
- Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period.
Patient inclusion criteria:
- HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
- Received palbociclib as a first line therapy.
- No prior or current enrolment in an interventional clinical trial for ABC/MBC.
- Minimum of six months of follow up data since palbociclib initiation.
Physician exclusion criteria:
- Qualified less than 2 years ago or more than 35 years ago.
- Participated in observational research for ABC/MBC in the last 3 months.
- Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.
Data sourced from ClinicalTrials.gov (NCT05155566). 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.