N/A
Completed N=195
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
Source: ClinicalTrials.gov NCT04460898 ↗Enrolled (actual)
195
Serious AEs
—
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants According to Year of Initial Diagnosis of Breast Cancer — 27; 28; 139; 1 Participants
Summary
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants According to Year of Initial Diagnosis of Breast Cancer |
27; 28; 139; 1 | — |
| PRIMARY Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status |
15; 16; 17; 11; 4; 3 | — |
| PRIMARY Number of Participants With Node Status |
44; 44; 14; 10; 6; 4 | — |
| PRIMARY Number of Participants With Menopausal Status |
7; 5; 183 | — |
| PRIMARY Number of Participants With Type of Metastatic Disease |
128; 67 | — |
| PRIMARY Number of Participants With Sites of Metastatic Disease |
8; 12; 141; 2; 47; 1 | — |
| PRIMARY Number of Participants With Total Number of Metastatic Sites |
82; 78; 35 | — |
| PRIMARY Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at the Time of Initiation of First-line Treatment |
68; 107; 17; 3; 0 | — |
| PRIMARY Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment |
25; 6; 9; 7; 4; 3 | — |
| PRIMARY Charlson Comorbidity Index (CCI) Score |
0.52 | — |
| PRIMARY Number of Participants Who Received Chemotherapy (Neo/Adjuvant) and Hormonal Therapy |
31; 51; 25 | — |
| PRIMARY Duration of Adjuvant Therapy |
41.7 | — |
| PRIMARY Time From Discontinuation of Adjuvant Therapy to Initiation of First-line Treatment |
39.32 | — |
| PRIMARY Number of Participants With Different Initial Palbociclib Dose |
166; 26; 1 | — |
| PRIMARY Total Number of Treatment Cycles Received |
13.73 | — |
| PRIMARY Number of Participants With Dose Reductions |
33 | — |
| PRIMARY Number of Participants With Increased Dose Patterns |
— | — |
| PRIMARY Number of Participants With Any Treatment Interruptions |
17 | — |
| PRIMARY Frequency of CBC Testing During First Cycle of Treatment |
2.07 | — |
| PRIMARY Frequency of Electrolyte Testing During First Cycle of First Line Treatment |
1.44 | — |
| PRIMARY Frequency of Liver Function Testing During First Cycle of First Line Treatment |
1.37 | — |
| PRIMARY Percentage of Participants With Progression Free Survival (PFS) at Month 6 |
92.7 | — |
| PRIMARY Percentage of Participants With Progression Free Survival (PFS) at Month 12 |
75.5 | — |
| PRIMARY Percentage of Participants With Progression Free Survival (PFS) at Month 18 |
51.6 | — |
| PRIMARY Percentage of Participants With Progression Free Survival (PFS) at Month 24 |
42.0 | — |
| PRIMARY Overall Survival (OS) |
NA | — |
| PRIMARY Percentage of Participants With Clinical Benefit Rate (CBR) |
83.08 | — |
| PRIMARY Objective Response Rate (ORR) |
65.13 | — |
| PRIMARY Number of Participants With Stable Disease Lasting Greater Than (>) 24 Weeks |
35 | — |
| PRIMARY Number of Participants Who Received Drug Regimen Post Discontinuation of Initial Endocrine-Based Therapy |
44; 28; 4 | — |
| PRIMARY Duration of Discontinued Therapy |
8.48 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Diagnosed with locoregional recurrent or metastatic female breast cancer.
- Pathologically confirmed HR-positive/HER2-negative diagnosis.
- Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:
- Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.
- At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.
- Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.
- ≥18 year old at initiation of palbociclib.
Exclusion Criteria
- No exclusion criteria will be imposed for the selection of patients.
Data sourced from ClinicalTrials.gov (NCT04460898). 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.